Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
3797 participants
INTERVENTIONAL
2014-08-31
2022-11-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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aCRT ON
The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise
aCRT ON
CRT device with AdaptivCRT enabled (AdaptivBiV and LV)
aCRT OFF
Standard CRT
aCRT OFF
CRT device with AdaptivCRT disabled
Interventions
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aCRT ON
CRT device with AdaptivCRT enabled (AdaptivBiV and LV)
aCRT OFF
CRT device with AdaptivCRT disabled
Eligibility Criteria
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Inclusion Criteria
* Subject is indicated for a CRT device according to local guidelines.
* Sinus Rhythm at time of enrollment
* Complete Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior to enrollment). Strauss Criteria used for LBBB.
* Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or equal to 200ms (within 30 days prior to enrollment).
* Left ventricular ejection fraction less than or equal to 35% (documented within 180 days prior to enrollment).
* NYHA class II, III or IV (documented within 30 days prior to enrollment) despite optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose of Beta-blockers and a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist.
Exclusion Criteria
* Subject is not expected to remain available for at least 2 years of follow-up visits.
* Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
* Subject is, or previously has been, receiving cardiac resynchronization therapy.
* Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
* Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 30 days prior to enrollment.
* Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study.
* Subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded).
* Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study.
* Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to device implant).
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Bruce Wilkoff, MD
Role: STUDY_CHAIR
The Cleveland Clinic
Locations
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CardioVascular Associates of Mesa
Mesa, Arizona, United States
Phoenix Cardiovascular Research Group, LLC
Phoenix, Arizona, United States
Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, United States
Scripps Green Hospital Scripps Clinic Torrey Pines
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Coggins & Levy Medical Associates
San Jose, California, United States
Stanford Hospital & Clinics
Stanford, California, United States
Saint Joseph's Medical Center
Stockton, California, United States
Penrose Hospital
Colorado Springs, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Heart & Vascular Institute of Florida
Clearwater, Florida, United States
Florida Heart Rhythm Specialists PLLC
Fort Lauderdale, Florida, United States
The Cardiac & Vascular Institute
Gainesville, Florida, United States
First Coast Cardiovascular Institute PA
Jacksonville, Florida, United States
Cardiovascular Research Center of South Florida
Miami, Florida, United States
AdventHealth Cardiovascular Research Institute
Orlando, Florida, United States
Cardiology Institute of Northwest Florida
Panama City, Florida, United States
University of South Florida Health (USF)
Tampa, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Northwerstern University
Chicago, Illinois, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
Saint Francis Medical Group Indiana Heart Physician
Indianapolis, Indiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
MedStar Health Research Institute
Baltimore, Maryland, United States
Massachusetts General Hospital (Boston MA)
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
William Beaumont Hospital
Troy, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States
North Memorial Heart and Vascular Institute
Robbinsdale, Minnesota, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, United States
Mid America Heart Institute (MAHI)
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Glacier View Research Institute Cardiology
Kalispell, Montana, United States
Lourdes Cardiology Services
Voorhees Township, New Jersey, United States
Presbyterian Heart Group
Albuquerque, New Mexico, United States
New York Methodist Hospital
Brooklyn, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
NYU Langone Medical Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Hudson Valley Heart Center
Poughkeepsie, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Central New York Cardiology
Utica, New York, United States
Asheville Cardiology Associate PA
Asheville, North Carolina, United States
Duke University Medical Center (DUMC)
Durham, North Carolina, United States
Wake Forest Baptist Health High Point Medical Center
High Point, North Carolina, United States
Raleigh Cardiology Associates
Raleigh, North Carolina, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
The Lindner Research Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
OhioHealth Research Institute
Columbus, Ohio, United States
Mount Carmel East
Columbus, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
North Ohio Heart-Elyria
Elyria, Ohio, United States
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, United States
Sacred Heart Medical Center
Eugene, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Capital Area Research
Camp Hill, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Mercer Bucks Cardiology
Newtown, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Great Valley Cardiology
Scranton, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Sutherland Cardiology Clinic
Memphis, Tennessee, United States
Centennial Heart Cardiovascular Consultants LLC
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, United States
The University of Texas (UT) Southwestern Medical Center
Dallas, Texas, United States
CHI St. Luke's Heath Baylor College of Medicine Medical Center
Houston, Texas, United States
Baylor Research Institute
Plano, Texas, United States
EP Heart LLC
The Woodlands, Texas, United States
Tyler Cardiovascular Consultants
Tyler, Texas, United States
University of Utah
Salt Lake City, Utah, United States
The University of Vermont Medical Center Inc
Burlington, Vermont, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Cardiovascular Specialists PC
Richmond, Virginia, United States
Virginia Commonwealth University Health System
Richmond, Virginia, United States
Swedish Medical Center Cherry Hill
Seattle, Washington, United States
Providence Spokane Cardiology
Spokane, Washington, United States
CAMC Health Education & Research Institute Inc
Charleston, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, United States
John Hunter Hospital
New Lambton, New South Wales, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Saint Vincent's Hospital (Sydney)
Sydney, , Australia
Landeskrankenhaus Innsbruck - Universitätskliniken
Innsbruck, , Austria
Allgemeines Krankenhaus der Stadt Linz
Linz, , Austria
AZ Sint-Jan Brugge-Oostende av
Bruges, , Belgium
Ziekenhuis Oost Limburg - Campus St.-Jan
Genk, , Belgium
London Health Sciences Centre - University Campus
London, , Canada
McGill Universtiy Health Centre (MUHC)
Montreal, , Canada
Southlake Regional Health Centre
Newmarket, , Canada
University of Ottawa Heart Institute
Ottawa, , Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, , Canada
Royal Columbian Hospital
Vancouver, , Canada
Vancouver General Hospital
Vancouver, , Canada
Odense Universitetshospital
Odense C, , Denmark
Keski-Suomen Keskussairaala
Jyväskylä, , Finland
Satakunnan keskussairaala
Pori, , Finland
Centre Hospitalier Universitaire de Amiens - Hôpital SU
Amiens, , France
CHRU Tours - Hôpital Trousseau
Chambray-lès-Tours, , France
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
Clermont-Ferrand, , France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, , France
CHRU La Rochelle
La Rochelle, , France
Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon
La Tronche, , France
CHRU de Lille
Lille, , France
groupe Hospitalier de L'Institut Catholique de Lille - Hôpital Saint-Philibert
Lomme, , France
Hopital prive Clairval - Ramsay Sante
Marseille, , France
Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille
Marseille, , France
Institut Hospitalier Jacques Cartier
Massy, , France
CHR Metz-Thionville Hôpital de Mercy
Metz, , France
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, , France
Nouvelles Cliniques Nantaises
Nantes, , France
CMC-Clinique Ambroise Pare
Neuilly-sur-Seine, , France
Hôpital Pontchaillou - CHU de Rennes
Rennes, , France
CHU Toulouse - Hôpital Rangueil
Toulouse, , France
Immanuel Diakonie Group - Evangelisch-Freikirchlichen Krankenhaus und Herzzentrum Brandenburg
Bernau bei Berlin, , Germany
Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
Bochum, , Germany
MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz
Chemnitz, , Germany
Klinikum Coburg GmbH
Coburg, , Germany
Praxisklinik Herz und Gefässe - Akademische Lehrpraxisklinik der TU Dresden
Dresden, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätskliniken des Saarlandes
Homburg/Saar, , Germany
Universitätsklinikum Jena - Friedrich Schiller Universität
Jena, , Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, , Germany
Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid
Lüdenscheid, , Germany
Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
Lüdenscheid, , Germany
Otto von Guericke Universität - Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, , Germany
Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus
Mönchengladbach, , Germany
Klinikum der Universität München - Campus Großhadern
München, , Germany
Herz Riesa, Gemeinschaftspraxis
Riesa, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Magyar Honvédség Honvédkorház
Budapest, , Hungary
Semmelweis Egyetem AOK
Budapest, , Hungary
Medanta - The Medicity
Gurgaon, , India
Fortis Escorts Heart Institute
New Delhi, , India
Policlinico Sant' Orsola - Malpighi
Bologna, , Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
Ospedale Civile Madonna Della Navicella
Chioggia, , Italy
Azienda Ospedaliera Carlo Poma
Mantova, , Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, , Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Hirosaki University Hospital
Hirosaki, Aomori, Japan
Chiba University Hospital
Chiba, , Japan
Kokura Memorial Hospital
Kitakyushu, , Japan
Kyorin University Hospital
Mitaka-Shi, , Japan
Nagoya University Hospital
Nagoya, , Japan
Sakakibara Heart Institute of Okayama
Okayama, , Japan
Saitama Medical Center Jichi Medical University
Shimonoseki-Shi, , Japan
National Cerebral and Cardiovascular Center
Suita-Shi, , Japan
Fujita Health University Hospital
Toyoake, , Japan
University of Fukui Hospital
Tsukuba, , Japan
Hospital Angeles Leon
León, Guanajuato, Mexico
Academisch Medisch Centrum
Amsterdam, , Netherlands
Amphia Ziekenhuis - Locatie Molengracht Breda
Breda, , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
Canisius-Wilhelmina ziekenhuis
Nijmegen, , Netherlands
Maasstad Ziekenhuis
Rotterdam, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Isala Klinieken - Locatie Weezenlanden
Zwolle, , Netherlands
Helse Bergen HF - Haukeland Universitetssjukehus
Bergen, , Norway
Wojewódzki Szpital Zespolony im. Ludwika Perzyny w Kaliszu
Kalisz, , Poland
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, , Poland
Regional Hospital Szpital Wojewodski
Kielce, , Poland
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
Lublin, , Poland
Spital Wojewodzki nr 2
Rzeszów, , Poland
Slaskie Centrum Chorob Serca
Zabrze, , Poland
Unidade Local de Saude do Baixo Alentejo, EPE - Hospital José Joaquim Fernandes
Beja, , Portugal
Centro Hospitalar de Coimbra
Coimbra, , Portugal
Hospital de Espírito Santo E.P.E.
Evora, , Portugal
The Arrhythmia Group
Coto Laurel, , Puerto Rico
Cardiovascular Center
San Juan, , Puerto Rico
AV Vishnevsky Institute of Surgery of the Ministry of Health of the Russian Federation
Moscow, , Russia
EN Meshalkin National medical research center of the Ministry of Health of the Russian Federation
Novosibirsk, , Russia
Almazov National Medical Research Centre
Saint Petersburg, , Russia
King Abdul Aziz University Hospital
Jeddah, , Saudi Arabia
King Fahad Armed Forces Hospital
Jeddah, , Saudi Arabia
King Faisal Specialist Hospital & Research Center
Riyadh, , Saudi Arabia
The College of Medicine & King Khalid University Hospital, King Saud University
Riyadh, , Saudi Arabia
Stredoslovensky ustav srdcovych a cievnych chorob a.s
Banská Bystrica, , Slovakia
NUSCH, a.s.
Bratislava, , Slovakia
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hospital Universitario Infanta Cristina
Badajoz, , Spain
Nuevo Hospital de Burgos
Burgos, , Spain
Hospital Virgen de la Arrixaca
El Palmar, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Clínico Virgen de la Victoria
Málaga, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Complexo Hospitalario Universitario de Vigo - Hospital Xeral Cíes
Vigo, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Karolinska Universitetssjukhuset
Solna, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Universitätsspital Basel
Basel, , Switzerland
HFR Fribourg - Hôpital cantonal
Fribourg, , Switzerland
Kantonsspital St.Gallen
Sankt Gallen, , Switzerland
National Taiwan University Hospital Hsin Chu Branch
Hsinchu, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Golden Jubilee National Hospital - NHS Trust
Glasgow, , United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, , United Kingdom
University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital
Liverpool, , United Kingdom
Royal Brompton & Harefield NHS Foundation Trust - Royal Brompton Hospital
London, , United Kingdom
Manchester University NHS Foundation Trust - Wythenshawe Hospital
Manchester, , United Kingdom
Countries
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References
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Wilkoff BL, Filippatos G, Leclercq C, Gold MR, Hersi AS, Kusano K, Mullens W, Felker GM, Kantipudi C, El-Chami MF, Essebag V, Pierre B, Philippon F, Perez-Gil F, Chung ES, Sotomonte J, Tung S, Singh B, Bozorgnia B, Goel S, Ebert HH, Varma N, Quan KJ, Salerno F, Gerritse B, van Wel J, Schaber DE, Fagan DH, Birnie D; AdaptResponse investigators. Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial. Lancet. 2023 Sep 30;402(10408):1147-1157. doi: 10.1016/S0140-6736(23)00912-1. Epub 2023 Aug 24.
Wilkoff BL, Birnie D, Gold MR, Hersi AS, Jacobs S, Gerritse B, Kusano K, Leclercq C, Mullens W, Filippatos G. Differences in clinical characteristics and reported quality of life of men and women undergoing cardiac resynchronization therapy. ESC Heart Fail. 2020 Oct;7(5):2972-2982. doi: 10.1002/ehf2.12914. Epub 2020 Aug 13.
Filippatos G, Birnie D, Gold MR, Gerritse B, Hersi A, Jacobs S, Kusano K, Leclercq C, Mullens W, Wilkoff BL; AdaptResponse Investigators. Rationale and design of the AdaptResponse trial: a prospective randomized study of cardiac resynchronization therapy with preferential adaptive left ventricular-only pacing. Eur J Heart Fail. 2017 Jul;19(7):950-957. doi: 10.1002/ejhf.895.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AdaptResponse
Identifier Type: -
Identifier Source: org_study_id