Clinical trial NCT02006069: MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing
Official title: MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: CRT, non responders, MultiPoint Pacing (MPP)
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 5850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.

Detailed description: This study is designed as a prospective, randomized, multi-center trial. Data will be collected at enrollment, baseline, implant procedure, patient classification, 6 months and 12 months of follow-up. During the 6-month visit, the patient's response to CRT will be evaluated according to LVESV reduction. Patients with an LVESV reduction of at least 15% will be classified as responders. These patients will terminate their participation in the study and return to the center's standard practice. Patients with an LVESV reduction less than 15% will be classified as non-responders and the MPP feature will be activated according to randomization result and they will be followed until the 12-month visit.

Eligibility criteria: Inclusion Criteria:

* Meets the current ESC Guidelines or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber ICDs)
* Must be willing and able to comply with study requirements
* Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form

Exclusion Criteria:

* Already had a CRT device implanted
* Myocardial Infarction, unstable angina within 40 days prior the enrollment
* Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
* Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
* Primary valvular disease
* Atrial Fibrillation:

  * Persistent AF at the time of enrollment
  * Permanent AF not treated with AV node ablation within 2 weeks from the CRT implant
  * History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment
* Unable to comply with the follow up schedule
* Less than 18 years of age
* Pregnant or are planning to become pregnant during the duration of the investigation
* Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
* Undergone a cardiac transplantation
* Life expectancy \< 12 months
* Currently participating in any other clinical investigation

Primary outcomes:
measure: Percentage of Non-responder Patients Who Converted to Responders
timeFrame: Non-responder to responder conversion rate between randomization at 6 months and 12 months
Secondary outcomes:
measure: Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase
timeFrame: Baseline vs 6 Months
measure: Clinical Composite Score Evaluation
timeFrame: Baseline vs 12 Months
measure: Reverse Left Ventricular (LV) Remodeling
timeFrame: Baseline vs 12 Months
measure: NYHA Class Changes
timeFrame: Baseline vs 12 Months
measure: 6MWT Changes
timeFrame: Baseline vs 12 Months
measure: Patient's QoL Score Changes (MLWHF)
timeFrame: Baseline vs 12 Months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC.
state: Alabama
city: Mesa
country: United States
facility: Cardiovascular Associates of Mesa
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: Bakersfield
country: United States
facility: Comprehensive Cardiovascular
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Reseda
country: United States
facility: Cardiac Rhythm Specialists, Inc.
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: Lakewood
country: United States
facility: Colorado Heart & Vascular, P.C.
state: Colorado
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Macon
country: United States
facility: Coliseum Medical Centers
state: Georgia
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Edgewood
country: United States
facility: St. Elizabeth Medical Center - South Unit
state: Kentucky
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Auburn Hills
country: United States
facility: McLaren Health Care Corporation
state: Michigan
city: Midland
country: United States
facility: MidMichigan Medical Center-Midland
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Omaha
country: United States
facility: CHI Health Creighton University Medical Center-Bergan Mercy
state: Nebraska
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Haddon Heights
country: United States
facility: Cardiology Associates of Fairfield County, PC
state: New Jersey
city: Corvallis
country: United States
facility: Samaritan Heart & Vascular Institute - Cardiology Dept.
state: Oregon
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: St. Francis Hospital
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Fort Worth
country: United States
facility: Baylor All Saints Medical Center at Fort Worth
state: Texas
city: Houston
country: United States
facility: Memorial Katy Cardiology Associates
state: Texas
city: Lufkin
country: United States
facility: Vivek Mangla, MD
state: Texas
city: The Woodlands
country: United States
facility: EP Heart
state: Texas
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Brisbane
country: Australia
facility: St. Andrews War Memorial Hospital
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Westmead
country: Australia
facility: Westmead Hospital
city: St. Poelten
country: Austria
facility: Krankenhaus der Stadt St. Poelten
city: Vienna
country: Austria
facility: Krankenhaus Hietzing
city: Vienna
country: Austria
facility: Wilhelminenspital
city: Brussels
country: Belgium
facility: Hopital Erasme
city: Gilly
country: Belgium
facility: St. Joseph Gilly
city: Calgary
country: Canada
facility: Foothills Medical Centre
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
city: Halifax
country: Canada
facility: QEII Health Sciences
city: Kingston
country: Canada
facility: Kingston General Hospital
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal
city: Montréal
country: Canada
facility: Hôtel Dieu de CHUM
city: Montréal
country: Canada
facility: McGill University Health Centre General Hospital
city: Sainte-Foy
country: Canada
facility: Institut de Cardiologie de Quebec
city: Sherbrooke
country: Canada
facility: CHUS Fleurimont
city: St. Johns
country: Canada
facility: HSC, Eastern Health
city: Toronto
country: Canada
facility: Rouge Valley Centenary
city: Vancouver
country: Canada
facility: St. Paul's Hospital
city: Hong Kong
country: China
facility: Prince of Wales Hospital
city: Cali
country: Colombia
facility: Angiografia Clinica de Occidente
city: Medellín
country: Colombia
facility: Clínica Cardio VID
city: Odense
country: Denmark
facility: Odense University Hospital
state: Fyn
city: Aalborg
country: Denmark
facility: Aalborg Sygehus Syd
state: Nordjylland
city: Aarhus
country: Denmark
facility: Skejby University Hospital
city: Jyvaskyla
country: Finland
facility: Keski-Suomi Central Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Marseille
country: France
facility: Hôpital Clairval
state: Alpes
city: Brest
country: France
facility: CHU Cavale Blanche
city: Chambray-lès-Tours
country: France
facility: CHU Trousseau
city: Dijon
country: France
facility: CHU François Mitterrand Dijon Bourgogne
city: Grenoble
country: France
facility: CHRU Albert Michallon
city: Lille
country: France
facility: CHRU Lille
city: Lomme
country: France
facility: Hopital Saint Philibert
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Montbéliard
country: France
facility: Centre Hospitalier de Belfort-Montbeliard
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: CHU de Nancy - Hopital de Brabois
city: Nantes
country: France
facility: CHU Hopital G. & R. Laënnec
city: Nantes
country: France
facility: Nouvelles cliniques Nantaises
city: Paris
country: France
facility: Centre Cardiologique Du Nord
city: Paris
country: France
facility: Hopital Pitiè Salpetrière
city: Paris
country: France
facility: Institute Cardio. Paris-Sud - Institut Jacques Cartier
city: Rennes
country: France
facility: CHRU Hôpital de Pontchaillou
city: Rouen
country: France
facility: CHRU Rouen Hospital Charles Nicolle
city: Saint-Denis Cedex
country: France
facility: CHR de La Reunion - Site du CHFG
city: Valence
country: France
facility: Centre Hospitalier de Valence
city: Villeurbanne
country: France
facility: Clinique du Tonkin
city: Singen
country: Germany
facility: Hegau-Bodensee-Hochrhein-Kliniken GmbH
state: Baden-Wurttemberg
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen
state: Baden-Württemberg
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik gGmbH
state: Hessen
city: Göttingen
country: Germany
facility: Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem
state: Niedersachsen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Köln
country: Germany
facility: Medizinische Einrichtungen der Universität zu Köln
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Evangelisches Krankenhaus Kalk gGmbH
state: Nordrhein-Westfalen
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabetes Zentrum NRW
city: Bad Rothenfelde
country: Germany
facility: Schuchtermann-Schillersche Kliniken
city: Berlin
country: Germany
facility: Charite Campus Virchow Klinikum
city: Berlin
country: Germany
facility: Universitatsmedizin Berlin - Campus Benjamin Franklin (CBF)
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld
city: Bochum
country: Germany
facility: Berufsgenossenschaftliche Kliniken Bergmannsheil
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Erfurt
country: Germany
facility: Helios-Klinikum Erfurt GmbH
city: Erlangen
country: Germany
facility: Kliniken der Friedrich-Alexander-Universität
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen GmbH
city: Greifswald
country: Germany
facility: Universitatsklinikum Greifswald
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen Georg-August-Universität
city: Gütersloh
country: Germany
facility: Klinikum Gütersloh gGmbH
city: Hamburg
country: Germany
facility: Albertinen-Krankenhaus Hamburg
city: Ingolstadt
country: Germany
facility: Klinikum Ingolstadt
city: Köln
country: Germany
facility: St. Vinzenz-Hospital
city: Leipzig
country: Germany
facility: Klinikum St. Georg gGMbH
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Ludenscheid
country: Germany
facility: Klinikum Ludenscheid
city: Lünen
country: Germany
facility: St.-Marien-Hospital GmbH
city: Muenster
country: Germany
facility: Universitatsklinikum Muenster
city: München
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Bruder
city: Villingen-Schwenningen
country: Germany
facility: Kliniken Villingen-Schwenningen
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Athens
country: Greece
facility: The Onassis Cardiac Center
city: Gurgaon
country: India
facility: Medanta - The Medicity Hospital
state: Haryana
city: Bangalore
country: India
facility: Fortis Hospital
state: Karnataka
city: Ahmedabad
country: India
facility: Care Institute of Medical Sciences
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education & Research
city: Chennai
country: India
facility: Apollo Hospital
city: Hyderabad
country: India
facility: CARE Banjara
city: New Delhi
country: India
facility: Medanta Medicity Hospital
city: New Delhi
country: India
facility: Escorts Heart Institute and Research Centre
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
city: Bari
country: Italy
facility: Az.Osp.Universitaria Consorziale Policlinico
city: Bari
country: Italy
facility: Azienda Ospedaliera Di Venere
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi
city: Brescia
country: Italy
facility: Az. Osp. Spedali Civili di Brescia
city: Caserta
country: Italy
facility: Azienda Ospedaliera S. Anna e S Sebastiano
city: Lecce
country: Italy
facility: Presidio Osp. Vito Fazzi
city: Naples
country: Italy
facility: Clinica Mediterranea
city: Naples
country: Italy
facility: Ospedale dei Pellegrini
city: Naples
country: Italy
facility: Ospedale S. Giovanni Bosco
city: Novara
country: Italy
facility: Az Osp.Universitaria Maggiore della Carità
city: Padova
country: Italy
facility: Università degli Studi di Padova
city: Peschiera del Garda
country: Italy
facility: Casa di Cura Dott. Pederzoli
city: Pisa
country: Italy
facility: Az. Osp. Universitaria Pisana-Presidio Santa Chiara
city: Portogruaro
country: Italy
facility: Ospedale di Portogruaro
city: Ragusa
country: Italy
facility: Azienda Ospedaliera "Civile - Maria Paternò Arezzo"
city: Roma
country: Italy
facility: Ospedale Madre G. Vannini
city: Roma
country: Italy
facility: Policlinico Casilino
city: Rome
country: Italy
facility: Ospedale S. Giovanni Calibita Fatebenefratelli di Roma
city: San Fermo della Battaglia
country: Italy
facility: Azienda Ospedaliera S. Anna
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza
city: Verona
country: Italy
facility: Ospedale Civile Maggiore di Verona Borgo Trento
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Seocho-gu
city: Bucheon-si
country: Korea, Republic of
facility: Sejong General Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Paola
country: Malta
facility: Mater Dei Hospital
city: Tilburg
country: Netherlands
facility: Twee Steden Ziekenhuis
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam Academic Medical Center (AMC)
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Zwolle
country: Netherlands
facility: Isala Ziekenhuis
city: Katowice
country: Poland
facility: Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca
state: Slaskie
city: Zabrze
country: Poland
facility: Slaskie Centrum Chorob Serca
state: Slask
city: Poznan
country: Poland
facility: Szpital Kliniczny Premienienia Panskiego
state: Wielkopolskie
city: Lodz
country: Poland
facility: Wojewodzki Specjalistyczny Szpital im. Bieganskiego
city: Braga
country: Portugal
facility: Hospital de Braga
city: Creixomil
country: Portugal
facility: Centro Hospitalar do Alto Ave, Unidade de Guimarães
city: Lisboa
country: Portugal
facility: Hospital Garcia de Orta, EPE
city: Lisbon
country: Portugal
facility: Hospital de Santa Cruz
city: Lisbon
country: Portugal
facility: Santa Maria Hospital
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova Gaia
city: Ponce
country: Puerto Rico
facility: Arrhythmia Group
city: San Juan
country: Puerto Rico
facility: Heart Rhythm Management
city: Jeddah
country: Saudi Arabia
facility: King Fahad Armed Forces Hospital
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
city: Singapore
country: Singapore
facility: National University Hospital
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu y Sant Pau
city: Granada
country: Spain
facility: Hospital Universitario Virgen de la Nieves
city: Madrid
country: Spain
facility: Complexo Hospitalario Universitario de Santiago
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Doce de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Malaga
country: Spain
facility: HCU Virgen de la Victoria
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
city: Geneva
country: Switzerland
facility: Hopital Cantonal Universitaire de Geneva
city: Taipei City
country: Taiwan
facility: National Taiwan University
state: Taipei
city: LinKou
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Ashington
country: United Kingdom
facility: Wansbeck General Hospital
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Brighton
country: United Kingdom
facility: The Royal Sussex Country Hospital
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: St. Thomas Hospital
city: Manchester
country: United Kingdom
facility: Manchester Heart Center, Manchester Royal Infirmary
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Swindon
country: United Kingdom
facility: The Great Western Hospital
Study officials:
affiliation: Centre Cardio-Pneumologique, CHU Pontchaillou
name: Christophe Leclercq
role: STUDY_CHAIR
References:
citation: Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Calo L, Vicentini A, Concha JF, Thibault B. Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I. Eur Heart J. 2019 Sep 14;40(35):2979-2987. doi: 10.1093/eurheartj/ehz109.
citation: Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Cohorn C, Thibault B; MORE-CRT MPP Investigators. Rationale and design of a randomized clinical trial to assess the safety and efficacy of multipoint pacing therapy: MOre REsponse on Cardiac Resynchronization Therapy with MultiPoint Pacing (MORE-CRT MPP-PHASE II). Am Heart J. 2019 Mar;209:1-8. doi: 10.1016/j.ahj.2018.12.004. Epub 2018 Dec 8.