Clinical trial NCT02066467: Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY® X4 - RALLY X4 Study
Official title: Maximizing CRT Delivery by Using Multipolar Coronary Sinus Lead Family ACUITY® X4
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heartfailure
Keywords: Phrenic Nerve Stimulation
Heartfailure treatment
CRT-D therapy
Quadripolar lead
Lead related complication free rate
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2014-02-19
Enrollment: 863
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The BSC Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for subjects with art failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:

* Moderate to severe heart failure (New York Heart Association (NYHA) Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms
* Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure BSCCRT-Ds are also intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

Brief summary: The objective of this study is to collect clinical data on safety and performance of ACUITY X4® leads when used in a standard clinical setting.

It is a prospective, non-randomized, observational multicenter study evaluating standard of care.

For Post Market Clinical Follow up (PMCF) purposes the 3 month implant success rate, adverse events and basic parameters of the lead will be assessed. The cohort of subjects included in this evaluation will be the first 200 subjects which are indicated for PMCF in Rally X4 to receive an ACUITY X4® lead implant.

Study endpoints:

Phrenic Nerve Stimulation (PNS) related CFR through 6 months post-implant (Defined as: rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold) Lead-related Complication-Free Rate (CFR) from Implant through 3 months post-implant.

Detailed description: Clinic visits will occur at:

* Enrollment and Consenting Clinic Visit (≤ 30 days prior to implant procedure)
* Implant Procedure (Day 0; all future follow ups based on this date)
* Pre-Discharge Clinic Visit (≤ 7 days post implant procedure) (Required)
* One to 6 Month Clinic Visit (20 to 180 days post implant procedure) (Required)
* Interim Visit(s) (Any time between the 1 to 6 Month Clinic Visit and Close-out Clinic Visit) (Following study center specific standard of care) (Device follow up optional) AE - reporting required
* Close-out Clinic Visit (30 months ± 90 days, OR 180 days ± 90 days after the study is closed to enrollment, whichever comes first) (Required)
* During the trial all AEs, deaths, and changes in the device system must be reported
* Devices of subjects who have received a Latitude device will be followed by the Boston Scientific (BSC) Latitude team. Device Data as defined in the Clinical Investigation Plan (CIP), device alerts, and diagnostic data from the standard Latitude database may be collected and entered into the study database at any time.

Eligibility criteria: Inclusion Criteria:

1. Subject is willing and capable of providing informed consent
2. Subject is planned to be implanted with an ACUITY X4® lead for left-ventricular pacing and sensing via the coronary venous system in conjunction with a compatible BSC pulse generator
3. Subject is willing and capable of participating in all visits associated with this study at an approved clinical study center and at the intervals defined by this CIP
4. Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

1. Subjects with a hypersensitivity to a maximum single dose of 0.51 mg dexamethasone acetate
2. Subject is enrolled in any other concurrent study without prior written approval from BSC, with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:

   * Schedule of procedures for the RALLY X4 Study (i.e. should not cause additional or missed visits);
   * RALLY X4 Study outcome (i.e. involve medications that could affect the heart rate of the subject);
   * Conduct of the RALLY X4 Study per GCP/ ISO 14155:2011/ local regulations as applicable
3. Per the implanting physician's discretion, the subject is not a suitable candidate to receive the study device as determined during the implant procedure
4. Women of childbearing potential who are or might be pregnant at the time of study enrollment or ACUITY X4® lead implant.
5. Subject is unwilling or unable to participate in all scheduled study follow up visits at an approved study center
6. Subject does not anticipate being a resident of the area for the scheduled duration of the trial
7. Subject's physician does not allow participation

   -

Primary outcomes:
measure: Phrenic Nerve Complication Free Rate
timeFrame: 6 months post-implant
Secondary outcomes:
measure: 3 Month Lead-related Complication-Free Rate (CFR)
timeFrame: 3 months post-implant
Other outcomes:
measure: 3 Month Implant Success Rate for Indicated Subjects
timeFrame: 3 months post-implant
Locations:
city: St.Pölten
country: Austria
facility: Landesklinikum St.Pölten
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Diegem
country: Belgium
facility: Guidant Europe SA / NV a Boston Scientific Company
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Bogota
country: Colombia
facility: Fundation Cardioinfantil
city: Cali
country: Colombia
facility: Fundación Valle del Lili
city: Medellin
country: Colombia
facility: Clinica Medellin
city: Copenhagen
country: Denmark
facility: Gentofte Hospital
city: Skejby
country: Denmark
facility: Aarhus University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Amiens
country: France
facility: CHU Amiens
city: Annecy
country: France
facility: Centre Hospitalier d'Annecy
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Marseille
country: France
facility: Hôpital de la Timone
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CH de Rouen
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bad Oeynhausen
country: Germany
facility: Herzzentrum Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Gera
country: Germany
facility: Waldklinikum Gera
city: Göttingen
country: Germany
facility: Herz-und Gefäßzentrum Göttingen
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Landshut
country: Germany
facility: Krankenhaus Landshut-Achdorf
city: Magdeburg
country: Germany
facility: University Magdeburg
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Waterford
country: Ireland
facility: Waterfort Hospital
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Petah Tikva
country: Israel
facility: Beilinson Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Rechovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola-Malpighi
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Catania
country: Italy
facility: Policlinico Vittorio Emanuele
city: Catanzaro
country: Italy
facility: Ospedale Pugliese Ciaccio
city: Como
country: Italy
facility: Azienda Ospedaliera Spedale Sant'Anna di Como
city: Mercogliano
country: Italy
facility: Clinica Montevergine
city: Rovigo
country: Italy
facility: Ospedale Santa Maria Misericordia
city: Verona
country: Italy
facility: Ospedale Borgo Trento
city: Amagasaki-Shi
country: Japan
facility: Kansai Rosai Hospital
city: Isehara-Shi
country: Japan
facility: Tokai University Hospital
city: Kamakura-Shi
country: Japan
facility: Shonan Kamakura General Hospital
city: Kitakyushu-Shi
country: Japan
facility: Kokura Memorial Hospital
city: Mitaka-Shi
country: Japan
facility: Kyorin University Hospital
city: Osaka-Shi
country: Japan
facility: Osaka General Medical Center
city: Osaka-Shi
country: Japan
facility: Osaka Police Hospital
city: Osaka-Shi
country: Japan
facility: Sakurabashi Watanabe Hospital
city: Sakai-Shi
country: Japan
facility: Osaka Rosai Hospital
city: Suita-Shi
country: Japan
facility: Osaka University Hospital
city: Yokohama-Shi
country: Japan
facility: Yokohama City University Hospital
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Arnheim
country: Netherlands
facility: Hospital Rijnstate
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Zwolle
country: Netherlands
facility: Isala
city: Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia
city: Guimaraes
country: Portugal
facility: Centro Hospitalar do Alto Ave
city: Lisbon
country: Portugal
facility: Hospital Santa Cruz
city: Lisbon
country: Portugal
facility: Hospital Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: National Heart Centre
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Madrid
country: Spain
facility: Doce De Octubre University Hospital
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Toledo
country: Spain
facility: Hospital Vírgen de la Salud
city: Valladolid
country: Spain
facility: Hospital Clinico Valladolid
city: Geneva
country: Switzerland
facility: Hôpital Cantonal de Genève
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: St. Gallen
country: Switzerland
facility: Institution Kantonsspital St. Gallen
city: Birmingham
country: United Kingdom
facility: Queen Elisabeth Hospital
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
Study officials:
affiliation: Hôpital Cantonal de Genève
name: Haran Burri, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Scientific Corporation
name: Torsten Kayser
role: STUDY_CHAIR
References: