Clinical trial NCT03464019: Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT).
Official title: Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia. NODE 301 and RAPID Studies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Paroxysmal Supraventricular Tachycardia
Keywords: Paroxysmal supraventricular tachycardia
cardiac monitoring
atrioventricular nodal reentrant tachycardia
atrioventricular reciprocating tachycardia
calcium channel blocker administered at home
conversion rate
Lead sponsor: Milestone Pharmaceuticals Inc.
Sponsor class: OTHER
Collaborators: name: Medpace, Inc.
name: IQVIA Biotech
First posted: 2018-03-13
Enrollment: 1097
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: NODE-301 study comprised 6 arms:

* 2 arms consisting of participants enrolled in Part 1 that treated a perceived episode of PSVT with randomized study drug (etripamil NS 70 mg or placebo) in a 2:1 ratio.
* 1 arm consisting of participants that only received the Test Dose in Part 1.
* 2 arms consisting of participants enrolled in Parts 2 and 3 that treated a perceived episode of PSVT with randomized study drug (etripamil NS 70 mg with optional second dose of 70 mg etripamil or placebo) in a 1:1 ratio and could be enrolled in the open-label period to treat an additional PSVT episode with etripamil
* 1 arm consisting of participants that only received the Test Dose in Parts 2 and 3.
Primary purpose: TREATMENT

Brief summary: This was a three-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray (NS) self-administered by participants who experienced an episode of paroxysmal supraventricular tachycardia (PSVT) in an at-home setting.

NODE-301 Part 1 included participants that received the randomized study drug to treat an episode of PSVT until the 150th positively adjudicated PSVT episode. Part 2 (also referred as the RAPID study) included participants that did not receive the randomized study drug in Part 1 and newly enrolled participants until the 180th positively adjudicated PSVT episode in Part 2. The study continued for approximately 6 months after the 180th positively adjudicated PSVT episode in Part 2 and this extension is referred to as Part 3 (also referred to as RAPID Extension).

Detailed description: NODE-301 was a three-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil NS self-administered by participants who experienced an episode of PSVT in an at-home setting. Each episode was documented by an ambulatory Cardiac Monitoring System (CMS) that was placed on the chest by the participants or caregiver when symptoms begin and recorded at least 5 hours of continuous electrocardiogram (ECG).

This was an event-driven study. The study comprised of three parts: Parts 1, 2, and 3.

NODE-301 Part 1 included participants that received the randomized study drug to treat an episode of PSVT until the 150th positively adjudicated PSVT episode (January 15th, 2020). Participants were randomized to etripamil 70 mg or placebo in a 2:1 ratio. Participants had a Test Dose Randomization Visit where they received 70 mg etripamil in sinus rhythm and a Treatment Period during which they could administer the randomized study drug during a perceived episode of PSVT.

Part 2 (also referred as the RAPID study) included participants that did not use the randomized study drug to treat a perceived episode of PSVT before the Part 1 data cutoff and newly enrolled participants. Before randomization in the RAPID study, all participants received a Test Dose of etripamil consisting of an initial dose of etripamil 70 mg followed by a second dose of etripamil 70 mg 10 minutes later to evaluate tolerability and to train participants on the study procedures. After a successful Test Dose, participants in Part 2 were randomized to etripamil or placebo in a 1:1 ratio. When experiencing a PSVT episode, participants were instructed to administer a first dose of randomized study drug (70 mg etripamil or placebo) followed 10 minutes later, if PSVT symptoms persisted, by a second dose of study drug (70 mg etripamil or placebo). After having administered the randomized study drug for a perceived episode of PSVT, participants could enter an open-label period during which they had the possibility to treat a second episode of PSVT with open-label etripamil (70 mg etripamil with optional second dose of 70 mg etripamil).

Part 2 continued until the 180th positively adjudicated PSVT episode (the data on which the primary efficacy analysis of RAPID was conducted) (July 20th 2022). The study continued for approximately 6 months after the 180th positively adjudicated PSVT episode in Part 2 and this extension is referred to as Part 3 (also referred to as RAPID Extension). The design of Parts 2 and 3 were the same and therefore their results are combined in this publication.

NODE-301 study comprised 6 arms:

* 2 arms consisting of participants enrolled in Part 1 that treated a perceived episode of PSVT with randomized study drug (etripamil NS 70 mg or placebo) in a 2:1 ratio.
* 1 arm consisting of participants that only received the Test Dose in Part 1.
* 2 arms consisting of participants enrolled in Parts 2 and 3 that treated a perceived episode of PSVT with randomized study drug (etripamil NS 70 mg with optional second dose of 70 mg etripamil or placebo) in a 1:1 ratio and could be enrolled in the open-label period to treat an additional PSVT episode with etripamil
* 1 arm consisting of participants that only received the Test Dose in Parts 2 and 3.

Eligibility criteria: Inclusion Criteria:

Participants who met all of the following criteria were eligible to participate in the study:

1. Male or female participants at least 18 years of age;
2. Electrographically documented history of PSVT (e.g., electrocardiogram \[ECG\] obtained during an episode of PSVT, Holter monitoring, loop recorder, etc). If participant had a prior ablation for PSVT, participant had to have documented ECG evidence of PSVT post-ablation;
3. History of sustained episodes of PSVT (i.e., typically lasting approximately 20 minutes or longer);
4. Females of childbearing potential who were sexually active with a male partner who were not surgically sterile (i.e., vasectomy) had to agree to use a highly effective form of contraception from the time of signed informed consent until 30 days after the last administration of study drug. Females of childbearing potential had to have a negative serum pregnancy test result at the Screening Visit and at the Final Study Visit, a negative urine pregnancy test at the Test Dose Randomization Visit and had to use a highly effective form of contraception between the visits.

   The following categories defined females who were NOT considered to be of childbearing potential:
   * Premenopausal females with 1 of the following:

     1. Documented hysterectomy,
     2. Documented bilateral salpingectomy or tubal ligation; or
     3. Documented bilateral oophorectomy, or
   * Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause;
5. Male participants, except those who were surgically sterile, had to use an approved highly effective form of contraception during the 3 days after any study drug administration; and
6. Signed written informed consent.

Exclusion Criteria:

Participants who met any of the following criteria were excluded from participation in the study:

1. Systolic blood pressure \<90 mmHg after a 5-minute rest in sitting position at the Screening Visit or before the Test Dose. In participants treated with a chronic prophylactic drug for PSVT (e.g., beta-blockers, verapamil, and diltiazem), the drug could be stopped for at least the equivalent of 5 half-lives, participants could be rescreened once, and chronic use of the drug could not be restarted after randomization;
2. History of severe symptoms of hypotension, especially syncope, during episodes of PSVT;
3. History of atrial arrhythmia that did not involve the AV node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, intra-atrial tachycardia);
4. History of allergic reaction to verapamil;
5. Current therapy with digoxin or any Class I or III antiarrhythmic drug, except if these drugs were stopped at least the equivalent of 5 half-lives before the Test Dose Randomization Visit;
6. Current chronic therapy with oral amiodarone, or had taken oral amiodarone within 30 days prior to the Test Dose Randomization Visit;
7. Evidence of ventricular pre-excitation (e.g., delta waves, short PR interval \<100 msec, Wolff-Parkinson-White syndrome) on the ECG performed at the Screening Visit or before the Test Dose administration;
8. Evidence of a second- or third-degree AV block on the ECG performed at the Screening Visit or before the Test Dose administration;
9. History or evidence of severe ventricular arrhythmia (e.g., torsades de pointes, ventricular fibrillation, or ventricular tachycardia);
10. Current congestive heart failure defined by the New York Heart Association Class II to IV;
11. History of Acute Coronary Syndrome or stroke within 6 months of screening;
12. Evidence of hepatic dysfunction defined as alanine aminotransferase or aspartate aminotransferase \>3 × the upper limit of normal (ULN) or total bilirubin \>2 × ULN at the Screening Visit, unless due to Gilbert syndrome;
13. Evidence of End-Stage Renal Disease as determined by an estimated glomerular filtration rate assessed at the Screening Visit of \<15 mL/min/1.73m2, or requiring hemodialysis;
14. Females who were pregnant or lactating;
15. Evidence or history of any significant physical or psychiatric condition including drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of participants, or affect their participation in the study. Additionally, the Investigator had the ability to exclude a participant if for any reason the Investigator judged the participant was not a good candidate for the study or would not be able to follow study procedures;
16. Participation in any investigational drug or device study or the use of any investigational drug or device within 30 days of the Screening Visit; or
17. Previously enrolled in a clinical trial for etripamil and received study drug during a perceived episode of PSVT.

Before randomization in the study, all participants received a Test Dose of an etripamil NS dosing regimen (etripamil 70 NS mg in Part 1 and in Parts 2 and 3 an initial dose of etripamil NS 70 mg followed by a second dose of etripamil NS 70 mg not earlier than 10 minutes and not later than 15 minutes after the first dose) to evaluate tolerability and to train participants on the study procedures. Participants who passed the Test Dose were randomized in the NODE-301 (2:1) or RAPID and RAPID Extension (2:1) study. A failure of the Test Dose was considered if participants met any of the following criteria occurring after administration of the either the first or second dose of etripamil NS 70 mg:

1. Any symptoms consistent with clinically severe hypotension such as pre-syncope, medically significant lightheadedness, syncope, nausea, or vomiting;
2. For participants with a pre-Test Dose Systolic Blood Pressure above 100 mmHg:

   1. Decrease in SBP ≥40 mmHg after Test Dose; or
   2. Post-Test Dose SBP \<80 mmHg;
3. For participants with a pre-Test Dose SBP between 90 mmHg and 100 mmHg (inclusive):

   a) Post-Test Dose SBP \<75 mmHg;
4. Third-degree AV block, Mobitz II second-degree AV block, or Wenckebach with bradycardia ≤40 bpm;
5. New, significant sinus bradycardia Heart Rate ≤40 bpm or sinus pauses (≤3 seconds), if considered by the Investigator to put the participant's safety at risk if either were to occur while not under medical supervision;
6. Any new ventricular arrhythmia considered significant by the Investigator; or
7. Atrial fibrillation, atrial flutter or atrial tachycardia (event lasting longer than 30 seconds);
8. Refusal of second dose of etripamil Test Dose regimen.

Participants who failed the Test Dose proceeded in the study as follows:

* If the Investigator identified a possible reversible cause of the initial Test Dose failure (e.g., concomitant medication such as beta-blocker), a re-challenge with a new Test Dose of etripamil dose regimen was possible after elimination of the reversible cause (e.g., withdrawal of concomitant therapy with the appropriate washout period). Participants could be randomized if they passed the second Test Dose and the cause of the Test Dose failure was eliminated for the duration of the study; or
* If the Investigator could not identify a reversible cause of the initial Test Dose failure, or if the potential cause could not be modified (e.g., necessary antihypertensive drug to control blood pressure), participants could not be randomized and completed a Final Study Visit. Participants who failed the Test Dose are part of the Test Dose Only Population.

Primary outcomes:
measure: The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration.
timeFrame: NODE-301 Part 1: Within 5 hours of start of study drug dosing. NODE-301 Parts 2 and 3: Within 30 minutes of start of study drug dosing.
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arrhythmia Research Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Cardiology
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Cerritos
country: United States
facility: Medvin Clinical Research
state: California
city: Encinitas
country: United States
facility: North Coast Cardiolog
state: California
city: Encinitas
country: United States
facility: Titan Medical Research - Oceanside
state: California
city: Los Alamitos
country: United States
facility: Los Alamitos Cardiovascular
state: California
city: Northridge
country: United States
facility: Amicis Research Center - Northridge
state: California
city: Palm Springs
country: United States
facility: RESPIRE Research
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates, P.C
state: Colorado
city: Norwalk
country: United States
facility: Cardiology Associates of Fairfield County
state: Connecticut
city: Boca Raton
country: United States
facility: FWD Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health Ambulatory Services d/b/a
state: Florida
city: Miami
country: United States
facility: United Health Research, LLC
state: Florida
city: Columbus
country: United States
facility: IACT Health
state: Georgia
city: Fayetteville
country: United States
facility: Piedmont Heart Institute- Fayetteville
state: Georgia
city: Fayetteville
country: United States
facility: Piedmont Heart Institute-Fayetteville
state: Georgia
city: Macon
country: United States
facility: Georgia Arrythmia Consultants&Research Institute
state: Georgia
city: Boise
country: United States
facility: St. Luke's Idaho Cardiology Associates
state: Idaho
city: Idaho Falls
country: United States
facility: Idaho Catalyst Clinical Research
state: Idaho
city: Elk Grove Village
country: United States
facility: AMITA Health Medical Group Heart & Vascular Elk Grpve Village
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Physicians Group - Cardiology
state: Indiana
city: West Des Moines
country: United States
facility: Mercy One Iowa Heart Center
state: Iowa
city: West Monroe
country: United States
facility: Clinical Trials of America, LLC - Monroe, LA
state: Louisiana
city: Baltimore
country: United States
facility: MedStar Health Research Institute - Chesapeake Cardiovascular Associates
state: Maryland
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Southgate
country: United States
facility: Revival Research Institute, LLC - Southgate, MI
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Research
state: Missouri
city: Elmer
country: United States
facility: Cardiovascular Associates of the Delaware Valley - Elmer
state: New Jersey
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System - Morristown Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: Cary
country: United States
facility: Cary Research Group, LLC
state: North Carolina
city: Charlotte
country: United States
facility: Sanger Heart and Vascular Institute
state: North Carolina
city: Charlotte
country: United States
facility: The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute
state: North Carolina
city: Cincinnati
country: United States
facility: Hatton Institute for Research & Education, Trihealth, Inc. - Cardiology
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University (OSU) Wexner Medical Center
state: Ohio
city: Marion
country: United States
facility: Rama Research LLC
state: Ohio
city: Springfield
country: United States
facility: Heart House Research Foundation, LLC
state: Ohio
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Columbia
country: United States
facility: Prisma Health Midlands
state: South Carolina
city: Rapid City
country: United States
facility: Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc
state: South Dakota
city: Allen
country: United States
facility: North Texas Research Associates
state: Texas
city: Denton
country: United States
facility: Cardiovascular Clinic of North Texas
state: Texas
city: Denton
country: United States
facility: Revival Research Institute, LLC
state: Texas
city: Fort Worth
country: United States
facility: Apex Trials Group
state: Texas
city: Houston
country: United States
facility: Angiocardiac Care of Texas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital: Baylor Scott & White Research Institute
state: Texas
city: Webster
country: United States
facility: Bay Area Heart
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Arlon
country: Belgium
facility: Clinique Du Sud- Luxembourg
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Bruxelles
country: Belgium
facility: UVC Brugmann University Hospital - Centre Hospitalier Universitaire (CHU)
city: Bruxelles
country: Belgium
facility: Universite Libre de Bruxelles (ULB) - Hopital Erasme
city: Edegem
country: Belgium
facility: Antwerp University Hospital (UZA)
city: Gilly
country: Belgium
facility: Grand Hopital de Charleroi (GHdC) - Site Saint-Joseph
city: Hasselt
country: Belgium
facility: Pharmacy Campus Virga Jesse (losplaats 7)
city: Leuven
country: Belgium
facility: University Hospital (UZ) Leuven
city: Liège
country: Belgium
facility: Regional Hospital Centre Citadelle
city: Mons
country: Belgium
facility: CHU Ambroise Pare
city: Yvoir
country: Belgium
facility: CHU UCL Namur - Site Godinne
city: Calgary
country: Canada
facility: Libin Cardiovascular Institute of Alberta - University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: North Vancouver
country: Canada
facility: Medical Arts Health Research Group - North Vancouver
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver Coastal Health Research
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Cardiac Arrhythmia Trials, Inc.
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba, St Boniface General Hospital
state: Manitoba
city: Halifax
country: Canada
facility: Dalhousie University - QEII Health Sciences Centre
state: Nova Scotia
city: Cambridge
country: Canada
facility: Cambridge Cardiac Care Centre
state: Ontario
city: Guelph
country: Canada
facility: Dawson Road Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Newmarket
country: Canada
facility: Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: The Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: CHUM Recherche Cardiologie
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Center - Research Institute
state: Quebec
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie De Quebec
state: Quebec
city: Saint-Jean-sur-Richelieu
country: Canada
facility: CardioVasc HR
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS
state: Quebec
city: Terrebonne
country: Canada
facility: CSSS du Sud de Lanaudiere - Hopital Pierre Le Gardeur
state: Quebec
city: Besançon
country: France
facility: CHRU Besancon - Hopital Jean Minjoz
state: Besancon
city: La Tronche
country: France
facility: CHU Grenoble-Alpes - Hopital Michallon
state: Grenoble
city: Brest
country: France
facility: CHRU de Brest - Hopital de la Cavale Blanche
city: Bron
country: France
facility: HCL Hopital Louis Pradel
city: La Rochelle
country: France
facility: Hopital Saint-Louis de La Rochelle
city: Lille
country: France
facility: CHU de Lille - Institut Cœur Poumon
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Lüdenscheid
country: Germany
facility: Maerkische Gesundheitsholding GmbH - Klinikum Luedenscheid
state: Ludenscheid
city: München
country: Germany
facility: Peter Osypka Herzzentrum Munchen
state: Munchen
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukoelln
city: Dresden
country: Germany
facility: FAZ Dresden-Neustadt GbR
city: Dresden
country: Germany
facility: Kardiologische Praxis
city: Papenburg
country: Germany
facility: Kardiologische Gemeinschaftspraxis Papenburg
city: Siegen
country: Germany
facility: Zentrum fuer Praevention und Rehabilitation
city: Bekescsaba
country: Hungary
facility: Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo
state: Bekescaba
city: Debrecen
country: Hungary
facility: Nehezlegzes Ambulancia
state: Debrecon
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai
city: Encs
country: Hungary
facility: CRU Hungary Kft.
city: Zalaegerszeg
country: Hungary
facility: Belvarosi Egeszseghaz
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum - Locatie Amersfoort
city: Arnhem
country: Netherlands
facility: Ziekenhuis Rijnstate - Locatie Arnhem
city: Beverwijk
country: Netherlands
facility: Rode Kruis Ziekenhuis
city: Blaricum
country: Netherlands
facility: Tergooiziekenhuizen Blaricum
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis - Locatie Breda Molengracht
city: Capelle Aan Den IJssel
country: Netherlands
facility: IJsselland ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Doetinchem
country: Netherlands
facility: Slingeland Ziekenhuis
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Hardenberg
country: Netherlands
facility: Ropcke-Zweers Ziekenhuis
city: Hoogeveen
country: Netherlands
facility: Treant Zorggroep
city: Leiderdorp
country: Netherlands
facility: Alrijne Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Schiedam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland - Locatie Vlietland
city: Utrecht
country: Netherlands
facility: Diakonessenhuis - Locatie Utrecht
city: Utrecht
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Kędzierzyn-Koźle
country: Poland
facility: American Heart of Poland S.A., IV Oddzial Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii
state: Kedzierzyn Kozle
city: Kraków
country: Poland
facility: Gabinety Daszmed
state: Krakov
city: Łódź
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi
state: Lodz
city: Łódź
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
state: Lodz
city: Rzeszów
country: Poland
facility: Kliniczny Szpital Wojewódzki nr 2, Rzeszów
state: Rzeszow
city: Bydgoszcz
country: Poland
facility: MICS Centrum Medyczne Torun
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Kermed
city: Katowice
country: Poland
facility: Specjalistyczna Praktyka Lekarska
city: Libiąż
country: Poland
facility: Prywatny Specjalistyczny Gabinet Internistyczny
city: Oswiecim
country: Poland
facility: MEDICOME Sp. z o.o.
city: Puławy
country: Poland
facility: SP ZOZ Szpital Specjalistyczny w Pulawach
city: Sopot
country: Poland
facility: NZOZ Pro Cordis Sopockie Centrum Badan Kardiologicznych
city: Toruń
country: Poland
facility: Osrodek Badan Klinicznych CLINSANTE S.C.
city: Tychy
country: Poland
facility: X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji
city: Warsaw
country: Poland
facility: Kardiosystem
city: Granada
country: Spain
facility: Martínez Hervás Cardiólogos
state: Andalucia
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia (HGUV)
state: Comunidad Valenciana
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Cordoba
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Malaga
city: El Palmar
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca
state: Murcia
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
state: Pontevedra
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Granada
country: Spain
facility: Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
city: Santiago De Compostela
country: Spain
facility: Hospital Universitario la Paz Rua Choupana
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Clínico Lozano Blesa
Study officials:
affiliation: Milestone Pharmaceuticals
name: David Bharucha, MD
role: STUDY_DIRECTOR
References: