MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing

NCT ID: NCT02006069

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5850 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2021-05-30

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MPP ON

MPP ON: feature is enabled

Group Type: EXPERIMENTAL

MPP

Intervention Type: DEVICE

All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device.

The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").

MPP OFF

MPP OFF: feature not enabled

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MPP

All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device.

The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe Leclercq

Role: STUDY_CHAIR

Centre Cardio-Pneumologique, CHU Pontchaillou

Locations

Heart Center Research, LLC.

Huntsville, Alabama, United States

Cardiovascular Associates of Mesa

Mesa, Arizona, United States

Phoenix Cardiovascular Research Group

Phoenix, Arizona, United States

Comprehensive Cardiovascular

Bakersfield, California, United States

Glendale Adventist Medical Center

Glendale, California, United States

Scripps Health

La Jolla, California, United States

Eisenhower Medical Center

Rancho Mirage, California, United States

Cardiac Rhythm Specialists, Inc.

Reseda, California, United States

San Diego Cardiac Center

San Diego, California, United States

Colorado Heart & Vascular, P.C.

Lakewood, Colorado, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Coliseum Medical Centers

Macon, Georgia, United States

Redmond Regional Medical Center

Rome, Georgia, United States

St. Elizabeth Medical Center - South Unit

Edgewood, Kentucky, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

McLaren Health Care Corporation

Auburn Hills, Michigan, United States

MidMichigan Medical Center-Midland

Midland, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

CHI Health Creighton University Medical Center-Bergan Mercy

Omaha, Nebraska, United States

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Cardiology Associates of Fairfield County, PC

Haddon Heights, New Jersey, United States

Samaritan Heart & Vascular Institute - Cardiology Dept.

Corvallis, Oregon, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

St. Francis Hospital

Greenville, South Carolina, United States

Erlanger Medical Center

Chattanooga, Tennessee, United States

Methodist University Hospital

Memphis, Tennessee, United States

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Baylor All Saints Medical Center at Fort Worth

Fort Worth, Texas, United States

Memorial Katy Cardiology Associates

Houston, Texas, United States

Vivek Mangla, MD

Lufkin, Texas, United States

EP Heart

The Woodlands, Texas, United States

Royal Adelaide Hospital

Adelaide, , Australia

Flinders Medical Centre

Bedford Park, , Australia

St. Andrews War Memorial Hospital

Brisbane, , Australia

The Alfred Hospital

Melbourne, , Australia

Westmead Hospital

Westmead, , Australia

Krankenhaus der Stadt St. Poelten

Sankt Pölten, , Austria

Krankenhaus Hietzing

Vienna, , Austria

Wilhelminenspital

Vienna, , Austria

Hopital Erasme

Brussels, , Belgium

St. Joseph Gilly

Gilly, , Belgium

Foothills Medical Centre

Calgary, , Canada

Royal Alexandra Hospital

Edmonton, , Canada

QEII Health Sciences

Halifax, , Canada

Kingston General Hospital

Kingston, , Canada

Hôtel Dieu de CHUM

Montreal, , Canada

Institut de Cardiologie de Montreal

Montreal, , Canada

McGill University Health Centre General Hospital

Montreal, , Canada

Institut de Cardiologie de Quebec

Sainte-Foy, , Canada

CHUS Fleurimont

Sherbrooke, , Canada

HSC, Eastern Health

St. Johns, , Canada

Rouge Valley Centenary

Toronto, , Canada

St. Paul's Hospital

Vancouver, , Canada

Prince of Wales Hospital

Hong Kong, , China

Angiografia Clinica de Occidente

Cali, , Colombia

Clínica Cardio VID

Medellín, , Colombia

Odense University Hospital

Odense, Fyn, Denmark

Aalborg Sygehus Syd

Aalborg, North Denmark, Denmark

Skejby University Hospital

Aarhus, , Denmark

Keski-Suomi Central Hospital

Jyväskylä, , Finland

Turku University Hospital

Turku, , Finland

Hôpital Clairval

Marseille, Alpes, France

CHU Cavale Blanche

Brest, , France

CHU Trousseau

Chambray-lès-Tours, , France

CHU François Mitterrand Dijon Bourgogne

Dijon, , France

CHRU Albert Michallon

Grenoble, , France

CHRU Lille

Lille, , France

Hopital Saint Philibert

Lomme, , France

Hôpital Saint Joseph

Marseille, , France

Centre Hospitalier de Belfort-Montbeliard

Montbéliard, , France

CHU Montpellier

Montpellier, , France

CHU de Nancy - Hopital de Brabois

Nancy, , France

CHU Hopital G. & R. Laënnec

Nantes, , France

Nouvelles cliniques Nantaises

Nantes, , France

Centre Cardiologique Du Nord

Paris, , France

Hopital Pitiè Salpetrière

Paris, , France

Institute Cardio. Paris-Sud - Institut Jacques Cartier

Paris, , France

CHRU Hôpital de Pontchaillou

Rennes, , France

CHRU Rouen Hospital Charles Nicolle

Rouen, , France

CHR de La Reunion - Site du CHFG

Saint-Denis, , France

Centre Hospitalier de Valence

Valence, , France

Clinique du Tonkin

Villeurbanne, , France

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, Germany

Hegau-Bodensee-Hochrhein-Kliniken GmbH

Singen, Baden-Wurttemberg, Germany

Kerckhoff-Klinik gGmbH

Bad Nauheim, Hesse, Germany

Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem

Göttingen, Lower Saxony, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Medizinische Einrichtungen der Universität zu Köln

Cologne, North Rhine-Westphalia, Germany

Evangelisches Krankenhaus Kalk gGmbH

Cologne, North Rhine-Westphalia, Germany

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, , Germany

Schuchtermann-Schillersche Kliniken

Bad Rothenfelde, , Germany

Charite Campus Virchow Klinikum

Berlin, , Germany

Universitatsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, , Germany

Klinikum Bielefeld

Bielefeld, , Germany

Berufsgenossenschaftliche Kliniken Bergmannsheil

Bochum, , Germany

Klinikum Coburg

Coburg, , Germany

St. Vinzenz-Hospital

Cologne, , Germany

Helios-Klinikum Erfurt GmbH

Erfurt, , Germany

Kliniken der Friedrich-Alexander-Universität

Erlangen, , Germany

Elisabeth-Krankenhaus Essen GmbH

Essen, , Germany

Universitätsmedizin Göttingen Georg-August-Universität

Göttingen, , Germany

Universitatsklinikum Greifswald

Greifswald, , Germany

Klinikum Gütersloh gGmbH

Gütersloh, , Germany

Albertinen-Krankenhaus Hamburg

Hamburg, , Germany

Klinikum Ingolstadt

Ingolstadt, , Germany

Klinikum St. Georg gGMbH

Leipzig, , Germany

Universitatsklinikum Leipzig

Leipzig, , Germany

Klinikum Ludenscheid

Lüdenscheid, , Germany

St.-Marien-Hospital GmbH

Lünen, , Germany

Deutsches Herzzentrum München des Freistaates Bayern

München, , Germany

Universitatsklinikum Muenster

Münster, , Germany

Klinikum Oldenburg

Oldenburg, , Germany

Krankenhaus der Barmherzigen Bruder

Trier, , Germany

Kliniken Villingen-Schwenningen

Villingen-Schwenningen, , Germany

Universitätsklinikum Würzburg

Würzburg, , Germany

The Onassis Cardiac Center

Athens, , Greece

Medanta - The Medicity Hospital

Gurgaon, Haryana, India

Fortis Hospital

Bangalore, Karnataka, India

Care Institute of Medical Sciences

Ahmedabad, , India

Postgraduate Institute of Medical Education & Research

Chandigarh, , India

Apollo Hospital

Chennai, , India

CARE Banjara

Hyderabad, , India

Medanta Medicity Hospital

New Delhi, , India

Escorts Heart Institute and Research Centre

New Delhi, , India

Rabin Medical Center

Petah Tikva, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Tel Aviv Medical Center

Tel Aviv, , Israel

Az.Osp.Universitaria Consorziale Policlinico

Bari, , Italy

Azienda Ospedaliera Di Venere

Bari, , Italy

Policlinico S.Orsola Malpighi

Bologna, , Italy

Az. Osp. Spedali Civili di Brescia

Brescia, , Italy

Azienda Ospedaliera S. Anna e S Sebastiano

Caserta, , Italy

Presidio Osp. Vito Fazzi

Lecce, , Italy

Clinica Mediterranea

Naples, , Italy

Ospedale dei Pellegrini

Naples, , Italy

Ospedale S. Giovanni Bosco

Naples, , Italy

Az Osp.Universitaria Maggiore della Carità

Novara, , Italy

Università degli Studi di Padova

Padua, , Italy

Casa di Cura Dott. Pederzoli

Peschiera del Garda, , Italy

Az. Osp. Universitaria Pisana-Presidio Santa Chiara

Pisa, , Italy

Ospedale di Portogruaro

Portogruaro, , Italy

Azienda Ospedaliera "Civile - Maria Paternò Arezzo"

Ragusa, , Italy

Ospedale Madre G. Vannini

Roma, , Italy

Policlinico Casilino

Roma, , Italy

Ospedale S. Giovanni Calibita Fatebenefratelli di Roma

Rome, , Italy

Azienda Ospedaliera S. Anna

San Fermo della Battaglia, , Italy

Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Ospedale Civile Maggiore di Verona Borgo Trento

Verona, , Italy

American University of Beirut Medical Center

Beirut, , Lebanon

Institut Jantung Negara

Kuala Lumpur, , Malaysia

Mater Dei Hospital

Paola, , Malta

Twee Steden Ziekenhuis

Tilburg, North Brabant, Netherlands

Amsterdam Academic Medical Center (AMC)

Amsterdam, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

Medisch Spectrum Twente

Enschede, , Netherlands

Isala Ziekenhuis

Zwolle, , Netherlands

Szpital Kliniczny Premienienia Panskiego

Poznan, Greater Poland Voivodeship, Poland

Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca

Katowice, Silesian Voivodeship, Poland

Slaskie Centrum Chorob Serca

Zabrze, Silesian Voivodeship, Poland

Wojewodzki Specjalistyczny Szpital im. Bieganskiego

Lodz, , Poland

Hospital de Braga

Braga, , Portugal

Centro Hospitalar do Alto Ave, Unidade de Guimarães

Creixomil, , Portugal

Hospital de Santa Cruz

Lisbon, , Portugal

Hospital Garcia de Orta, EPE

Lisbon, , Portugal

Santa Maria Hospital

Lisbon, , Portugal

Centro Hospitalar Vila Nova Gaia

Vila Nova de Gaia, , Portugal

Arrhythmia Group

Ponce, , Puerto Rico

Heart Rhythm Management

San Juan, , Puerto Rico

King Fahad Armed Forces Hospital

Jeddah, , Saudi Arabia

King Fahad Medical City

Riyadh, , Saudi Arabia

National University Hospital

Singapore, , Singapore

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

Seoul St. Mary's Hospital

Seoul, Seocho-gu, South Korea

Sejong General Hospital

Bucheon-si, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Yonsei University Health System

Seoul, , South Korea

Hospital Universitario A Coruña

A Coruña, , Spain

Hospital Universitario Infanta Cristina

Badajoz, , Spain

Hospital de la Santa Creu y Sant Pau

Barcelona, , Spain

Hospital Universitario Virgen de la Nieves

Granada, , Spain

Complexo Hospitalario Universitario de Santiago

Madrid, , Spain

Fundación Jiménez Díaz

Madrid, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Hospital Ramon y Cajal

Madrid, , Spain

Hospital Universitario Doce de Octubre

Madrid, , Spain

Hospital Universitario Puerta de Hierro

Madrid, , Spain

HCU Virgen de la Victoria

Málaga, , Spain

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Hospital Alvaro Cunqueiro

Vigo, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Karolinska University Hospital Huddinge

Stockholm, , Sweden

Hopital Cantonal Universitaire de Geneva

Geneva, , Switzerland

National Taiwan University

Taipei City, Taipei, Taiwan

Chang Gung Memorial Hospital

Linkou District, , Taiwan

Wansbeck General Hospital

Ashington, , United Kingdom

Queen Elizabeth Hospital

Birmingham, , United Kingdom

The Royal Sussex Country Hospital

Brighton, , United Kingdom

Golden Jubilee National Hospital

Glasgow, , United Kingdom

Kings College Hospital

London, , United Kingdom

St. Thomas Hospital

London, , United Kingdom

Manchester Heart Center, Manchester Royal Infirmary

Manchester, , United Kingdom

John Radcliffe Hospital

Oxford, , United Kingdom

Southampton General Hospital

Southampton, , United Kingdom

The Great Western Hospital

Swindon, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Canada; China; Colombia; Denmark; Finland; France; Germany; Greece; India; Israel; Italy; Lebanon; Malaysia; Malta; Netherlands; Poland; Portugal; Puerto Rico; Saudi Arabia; Singapore; South Korea; Spain; Sweden; Switzerland; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30859220 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30616009 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-13-006-ID-HF

Identifier Type: -

Identifier Source: org_study_id