AdaptResponse Clinical Trial

The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).

Study Overview

• Status: Completed
• Conditions: Heart Failure With Left Bundle Branch Block
• Intervention / Treatment: Device: aCRT OFF; Device: aCRT ON

• Study Type: Interventional
• Enrollment (Actual): 3797
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia
    • Saint Vincent's Hospital (Sydney)
  • New South Wales
    • New Lambton, New South Wales, Australia
      • John Hunter Hospital
  • Victoria
    • Heidelberg, Victoria, Australia
      • Austin Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia
      • Fiona Stanley Hospital
• Austria
  • Innsbruck, Austria
    • Landeskrankenhaus Innsbruck - Universitätskliniken
  • Linz, Austria
    • Allgemeines Krankenhaus der Stadt Linz
• Belgium
  • Brugge, Belgium
    • AZ Sint-Jan Brugge-Oostende AV
  • Genk, Belgium
    • Ziekenhuis Oost Limburg - Campus St.-Jan
• Canada
  • London, Canada
    • London Health Sciences Centre - University Campus
  • Montreal, Canada
    • McGill Universtiy Health Centre (MUHC)
  • Newmarket, Canada
    • Southlake Regional Health Centre
  • Ottawa, Canada
    • University of Ottawa Heart Institute
  • Quebec, Canada
    • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
  • Vancouver, Canada
    • Royal Columbian Hospital
  • Vancouver, Canada
    • Vancouver General Hospital
• Denmark
  • Odense C, Denmark, 5000
    • Odense Universitetshospital
• Finland
  • Jyväskylä, Finland
    • Keski-Suomen Keskussairaala
  • Pori, Finland
    • Satakunnan Keskussairaala
• France
  • Amiens, France
    • Centre Hospitalier Universitaire de Amiens - Hôpital SU
  • Chambray lès tours, France
    • CHRU Tours - Hopital Trousseau
  • Clermont-Ferrand, France
    • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
  • Corbeil-Essonnes, France
    • Centre Hospitalier Sud Francilien
  • La Rochelle, France, 17019
    • CHRU La Rochelle
  • La Tronche, France
    • Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon
  • Lille, France
    • CHRU de Lille
  • Lomme, France
    • groupe Hospitalier de L'Institut Catholique de Lille - Hôpital Saint-Philibert
  • Marseille, France
    • Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille
  • Marseille, France
    • Hopital prive Clairval - Ramsay Sante
  • Massy, France
    • Institut Hospitalier Jacques Cartier
  • Metz, France
    • CHR Metz-Thionville Hopital de Mercy
  • Montpellier Cedex 5, France
    • CHRU de Montpellier - Hôpital Arnaud de Villeneuve
  • Nantes, France
    • Nouvelles Cliniques Nantaises
  • Neuilly-sur-Seine, France
    • CMC-Clinique Ambroise Pare
  • Rennes Cedex 9, France
    • Hopital Pontchaillou - CHU de Rennes
  • Toulouse Cedex 9, France
    • CHU Toulouse - Hopital Rangueil
• Germany
  • Bernau bei Berlin, Germany
    • Immanuel Diakonie Group - Evangelisch-Freikirchlichen Krankenhaus und Herzzentrum Brandenburg
  • Bochum, Germany
    • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
  • Chemnitz, Germany
    • MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz
  • Coburg, Germany
    • Klinikum Coburg GmbH
  • Dresden, Germany
    • Praxisklinik Herz und Gefässe - Akademische Lehrpraxisklinik der TU Dresden
  • Düsseldorf, Germany
    • Universitatsklinikum Dusseldorf
  • Heidelberg, Germany
    • Universitatsklinikum Heidelberg
  • Homburg/Saar, Germany
    • Universitätskliniken des Saarlandes
  • Jena, Germany
    • Universitätsklinikum Jena - Friedrich Schiller Universität
  • Lübeck, Germany
    • Universitätsklinikum Schleswig-Holstein - Campus Lübeck
  • Lüdenscheid, Germany, 58515
    • Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid
  • Lüdenscheid, Germany
    • Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
  • Magdeburg, Germany, 39120
    • Otto von Guericke Universität - Universitätsklinikum Magdeburg A.ö.R.
  • Mönchengladbach, Germany
    • Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus
  • München, Germany
    • Klinikum der Universität München - Campus Grosshadern
  • Riesa, Germany
    • Herz Riesa, Gemeinschaftspraxis
  • Ulm, Germany, 89801
    • Universitatsklinikum Ulm
• Hungary
  • Budapest, Hungary
    • Semmelweis Egyetem AOK
  • Budapest, Hungary
    • Magyar Honvédség Honvédkorház
• India
  • Gurgaon, India
    • Medanta - The Medicity
  • New Delhi, India
    • Fortis Escorts Heart Institute
• Italy
  • Bologna, Italy
    • Policlinico Sant' Orsola - Malpighi
  • Brescia, Italy
    • Azienda Ospedaliera Spedali Civili di Brescia
  • Chioggia, Italy
    • Ospedale Civile Madonna Della Navicella
  • Mantova, Italy
    • Azienda Ospedaliera Carlo Poma
  • Parma, Italy
    • Azienda Ospedaliero-Universitaria di Parma
  • Verona, Italy
    • Azienda Ospedaliera Universitaria Integrata Verona
• Japan
  • Chiba-Shi, Japan
    • Chiba University Hospital
  • Kitakyushu, Japan
    • Kokura Memorial Hospital
  • Mitaka-Shi, Japan
    • Kyorin University Hospital
  • Nagoya, Japan
    • Nagoya University Hospital
  • Okayama-Shi, Japan
    • Sakakibara Heart Institute of Okayama
  • Shimonoseki-Shi, Japan
    • Saitama Medical Center Jichi Medical University
  • Suita-Shi, Japan
    • National Cerebral and Cardiovascular Center
  • Toyoake, Japan
    • Fujita Health University Hospital
  • Tsukuba, Japan
    • University of Fukui Hospital
  • Aomori Prefecture
    • Hirosaki, Aomori Prefecture, Japan
      • Hirosaki University Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of
    • Yeungnam University Medical Center
  • Gyeonggi-Do, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Kyung Hee University Hospital
• Mexico
  • Guanajuato
    • Leon, Guanajuato, Mexico
      • Hospital Angeles Leon
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis - Locatie Molengracht Breda
  • Leeuwarden, Netherlands
    • Medisch Centrum Leeuwarden
  • Nijmegen, Netherlands
    • Canisius-Wilhelmina Ziekenhuis
  • Rotterdam, Netherlands
    • Erasmus Medisch Centrum
  • Rotterdam, Netherlands, 3078 HT
    • Maasstad Ziekenhuis
  • Utrecht, Netherlands
    • Universitair Medisch Centrum Utrecht
  • Zwolle, Netherlands, 8011 JW
    • Isala Klinieken - Locatie Weezenlanden
• Norway
  • Bergen, Norway
    • Helse Bergen HF - Haukeland Universitetssjukehus
• Poland
  • Kalisz, Poland
    • Wojewódzki Szpital Zespolony im. Ludwika Perzyny w Kaliszu
  • Katowice, Poland
    • Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
  • Kielce, Poland
    • Regional Hospital Szpital Wojewodski
  • Lublin, Poland
    • Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
  • Rzeszów, Poland
    • Spital Wojewodzki nr 2
  • Zabrze, Poland
    • Slaskie Centrum Chorob Serca
• Portugal
  • Beja, Portugal
    • Unidade Local de Saude do Baixo Alentejo, EPE - Hospital José Joaquim Fernandes
  • Coimbra, Portugal, 3041-801
    • Centro Hospitalar de Coimbra
  • Évora, Portugal, 7000
    • Hospital de Espírito Santo E.P.E.
• Puerto Rico
  • Coto Laurel, Puerto Rico
    • The Arrhythmia Group
  • San Juan, Puerto Rico
    • Cardiovascular Center
• Russian Federation
  • Moscow, Russian Federation
    • AV Vishnevsky Institute of Surgery of the Ministry of Health of the Russian Federation
  • Novosibirsk, Russian Federation
    • EN Meshalkin National medical research center of the Ministry of Health of the Russian Federation
  • St Petersburg, Russian Federation
    • Almazov National Medical Research Centre
• Saudi Arabia
  • Jeddah, Saudi Arabia
    • King Abdul Aziz University Hospital
  • Jeddah, Saudi Arabia
    • King Fahad Armed Forces Hospital
  • Riyadh, Saudi Arabia
    • King Faisal Specialist Hospital & Research Center
  • Riyadh, Saudi Arabia
    • The College of Medicine & King Khalid University Hospital, King Saud University
• Slovakia
  • Banska Bystrica, Slovakia
    • Stredoslovensky ustav srdcovych a cievnych chorob a.s
  • Bratislava 37, Slovakia, 83348
    • NUSCH, a.s.
• Spain
  • Badajoz, Spain
    • Hospital Universitario Infanta Cristina
  • Burgos, Spain
    • Nuevo Hospital de Burgos
  • El Palmar, Spain
    • Hospital Virgen de la Arrixaca
  • Granada, Spain
    • Hospital Universitario Virgen De Las Nieves
  • Málaga, Spain
    • Hospital Clínico Virgen de la Victoria
  • Salamanca, Spain
    • Hospital Clinico Universitario de Salamanca
  • Santa Cruz de Tenerife, Spain
    • Hospital Universitario Nuestra Señora de Candelaria
  • Sevilla, Spain
    • Hospital Universitario Virgen del Rocio
  • Vigo, Spain
    • Complexo Hospitalario Universitario de Vigo - Hospital Xeral Cíes
  • Zaragoza, Spain
    • Hospital Universitario Miguel Servet
• Sweden
  • Solna, Sweden
    • Karolinska Universitetssjukhuset
  • Uppsala, Sweden
    • Akademiska sjukhuset
• Switzerland
  • Basel, Switzerland, 4031
    • Universitätsspital Basel
  • Fribourg, Switzerland
    • HFR Fribourg - Hôpital Cantonal
  • Saint Gallen, Switzerland
    • Kantonsspital St.Gallen
• Taiwan
  • Hsinchu, Taiwan, 30059
    • National Taiwan University Hospital Hsin Chu Branch
  • Taipei, Taiwan
    • National Taiwan University Hospital
• United Kingdom
  • Glasgow, United Kingdom
    • Golden Jubilee National Hospital - NHS Trust
  • Liverpool, United Kingdom
    • Liverpool Heart and Chest Hospital NHS Foundation Trust
  • Liverpool, United Kingdom
    • University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital
  • London, United Kingdom
    • Royal Brompton & Harefield NHS Foundation Trust - Royal Brompton Hospital
  • Manchester, United Kingdom
    • Manchester University NHS Foundation Trust - Wythenshawe Hospital
• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • CardioVascular Associates of Mesa
    • Phoenix, Arizona, United States, 85018-3956
      • Phoenix Cardiovascular Research Group, LLC
  • Arkansas
    • Little Rock, Arkansas, United States, 72205-6202
      • Saint Vincent Heart Clinic Arkansas
  • California
    • La Jolla, California, United States, 92037-1027
      • Scripps Green Hospital Scripps Clinic Torrey Pines
    • Los Angeles, California, United States, 90048-5913
      • Cedars-Sinai Medical Center
    • San Jose, California, United States, 95124
      • Coggins & Levy Medical Associates
    • Stanford, California, United States, 94305-2200
      • Stanford Hospital & Clinics
    • Stockton, California, United States, 95204
      • Saint Joseph's Medical Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80907-6863
      • Penrose Hospital
    • Loveland, Colorado, United States, 80528
      • Medical Center of the Rockies
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606-4284
      • Bridgeport Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010-3017
      • Washington Hospital Center
  • Florida
    • Clearwater, Florida, United States, 33756-3367
      • Heart & Vascular Institute of Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Florida Heart Rhythm Specialists PLLC
    • Gainesville, Florida, United States
      • The Cardiac & Vascular Institute
    • Jacksonville, Florida, United States, 32256-6954
      • First Coast Cardiovascular Institute PA
    • Miami, Florida, United States
      • Cardiovascular Research Center of South Florida
    • Orlando, Florida, United States, 32803-1248
      • AdventHealth Cardiovascular Research Institute
    • Panama City, Florida, United States, 32401-3665
      • Cardiology Institute of Northwest Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida Health (USF)
  • Georgia
    • Atlanta, Georgia, United States, 30308-2225
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States
      • Piedmont Heart Institute
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwerstern University
    • Springfield, Illinois, United States, 62769-0002
      • Prairie Education and Research Cooperative
  • Indiana
    • Indianapolis, Indiana, United States, 46237-6345
      • Saint Francis Medical Group Indiana Heart Physician
  • Louisiana
    • New Orleans, Louisiana, United States, 70121-2429
      • Ochsner Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21237-3958
      • Medstar Health Research Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02114-2621
      • Massachusetts General Hospital (Boston MA)
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5853
      • University of Michigan
    • Lansing, Michigan, United States, 48912
      • Sparrow Clinical Research Institute
    • Troy, Michigan, United States, 48098-6375
      • William Beaumont Hospital
    • Ypsilanti, Michigan, United States, 48197-8633
      • Michigan Heart
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center Fairview
    • Robbinsdale, Minnesota, United States, 55422-2926
      • North Memorial Heart and Vascular Institute
    • Saint Paul, Minnesota, United States, 55102-2568
      • United Heart and Vascular Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • Mid America Heart Institute (MAHI)
    • Saint Louis, Missouri, United States, 63110-1010
      • Washington University School of Medicine
  • Montana
    • Kalispell, Montana, United States, 59901
      • Glacier View Research Institute Cardiology
  • New Jersey
    • Voorhees, New Jersey, United States, 08043-4322
      • Lourdes Cardiology Services
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106-4921
      • Presbyterian Heart Group
  • New York
    • Brooklyn, New York, United States
      • New York Methodist Hospital
    • New York, New York, United States
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States
      • Weill Medical College of Cornell University
    • New York, New York, United States
      • NYU Langone Medical Center
    • Poughkeepsie, New York, United States
      • Hudson Valley Heart Center
    • Stony Brook, New York, United States
      • Stony Brook University Medical Center
    • Utica, New York, United States
      • Central New York Cardiology
  • North Carolina
    • Asheville, North Carolina, United States
      • Asheville Cardiology Associate PA
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center (DUMC)
    • High Point, North Carolina, United States
      • Wake Forest Baptist Health High Point Medical Center
    • Raleigh, North Carolina, United States
      • Raleigh Cardiology Associates
  • Ohio
    • Cincinnati, Ohio, United States
      • The Lindner Research Center
    • Cincinnati, Ohio, United States
      • Bethesda North Hospital
    • Cleveland, Ohio, United States
      • Cleveland Clinic
    • Cleveland, Ohio, United States
      • University Hospitals Case Medical Center
    • Columbus, Ohio, United States, 43214
      • OhioHealth Research Institute
    • Columbus, Ohio, United States
      • The Ohio State University
    • Columbus, Ohio, United States
      • Mount Carmel East
    • Elyria, Ohio, United States
      • North Ohio Heart-Elyria
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Oklahoma Heart Hospital Research Foundation
  • Oregon
    • Eugene, Oregon, United States
      • Sacred Heart Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States
      • Lehigh Valley Hospital
    • Camp Hill, Pennsylvania, United States
      • Capital Area Research
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Hospital
    • Newtown, Pennsylvania, United States
      • Mercer Bucks Cardiology
    • Philadelphia, Pennsylvania, United States
      • Thomas Jefferson University Hospital
    • Philadelphia, Pennsylvania, United States
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States
      • University of Pittsburgh Medical Center UPMC Presbyterian
    • Scranton, Pennsylvania, United States, 18510
      • Great Valley Cardiology
  • South Carolina
    • Charleston, South Carolina, United States
      • Medical University of South Carolina (MUSC)
  • Tennessee
    • Memphis, Tennessee, United States
      • Sutherland Cardiology Clinic
    • Nashville, Tennessee, United States
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States
      • Centennial Heart Cardiovascular Consultants LLC
  • Texas
    • Austin, Texas, United States
      • Texas Cardiac Arrhythmia Research
    • Dallas, Texas, United States
      • The University of Texas (UT) Southwestern Medical Center
    • Houston, Texas, United States
      • CHI St. Luke's Heath Baylor College of Medicine Medical Center
    • Plano, Texas, United States, 75093
      • Baylor Research Institute
    • The Woodlands, Texas, United States
      • EP Heart LLC
    • Tyler, Texas, United States
      • Tyler Cardiovascular Consultants
  • Utah
    • Salt Lake City, Utah, United States
      • University of Utah
  • Vermont
    • Burlington, Vermont, United States
      • The University of Vermont Medical Center Inc
  • Virginia
    • Charlottesville, Virginia, United States
      • University of Virginia Medical Center
    • Norfolk, Virginia, United States
      • Sentara Norfolk General Hospital
    • Richmond, Virginia, United States
      • Virginia Commonwealth University Health System
    • Richmond, Virginia, United States
      • Virginia Cardiovascular Specialists PC
  • Washington
    • Seattle, Washington, United States
      • Swedish Medical Center Cherry Hill
    • Spokane, Washington, United States
      • Providence Spokane Cardiology
  • West Virginia
    • Charleston, West Virginia, United States
      • CAMC Health Education & Research Institute Inc
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Cardiovascular Services
    • Milwaukee, Wisconsin, United States, 53211
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject is willing to sign and date the study Patient Informed Consent Form.
• 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 less than 18 years of age (or has not reached minimum age per local law).
• 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).
• Subject meets any exclusion criteria required by local law.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aCRT ON; The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise	Device: aCRT ON; CRT device with AdaptivCRT enabled (AdaptivBiV and LV)
Active Comparator: aCRT OFF; Standard CRT	Device: aCRT OFF; CRT device with AdaptivCRT disabled

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation	The first occurrence of death or intervention for heart failure decompensation (defined as an event requiring invasive intervention or inpatient hospitalization).	from subject randomization until the first occurrence of death or intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Mortality	All-cause mortality in the aCRT ON group vs the aCRT OFF group	from subject randomization until the occurrence of death, median follow-up 4.9 years (max. follow-up 8.1 years)
Percent of Patients With Interventions for Heart Failure Decompensation	First occurence of intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.	from subject randomization until the first occurrence of intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years)
Clinical Composite Score	The Clinical Composite Score (CCS) classifies patients according their clinical status at 6 months post randomization into categories Improved, Unchanged, and Worsened. A patient is classified Worsened in case of death, hospitalization for worsening heart failure, worsened NYHA class (using last observation carried forward), or worsened status on the Global Assessment Score. Also patients that exit the study or cross over because of worsening heart failure are classified Worsened. A patient is classified Improved when not Worsened and there is an improvement in NYHA class or Global Assessment Score. Patients that are not Worsened or Improved are Unchanged.	CCS at 6 month post randomization
Atrial Fibrillation	Occurrence of atrial fibrillation lasting >6 hours in one day	from subject randomization until the first occurrence of atrial fibrillation lasting >6 hours in one day, median follow-up 4.9 years (max. follow-up 8.1 years)
Change in Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	The overall summary score of the Kansas City Cardiomyopathy Questionnaire will be analyzed. The KCCQ measures Quality of Life on a 0-100 scale with higher scores indicating better QoL	from baseline to 24M follow up
Change in Quality of Life Measured by the EQ-5D	The EQ-5D descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems (labelled 1-3). We calculated the EQ-5D summary index by applying a specific formula providing a valuation to the health states (Shaw et al. Medical Care 2005). For the summary index, value 0 represents health that is valued as equal to death and value 1 represents best possible health.	from baseline to 24M follow up
All-cause Re-admissions Within 30 Days After a Heart Failure Admission Per 100 Patient Years	All-cause hospital re-admissions within 30 days after discharge from a heart failure admission are reported as number of cases per 100 patient years	from subject randomization until study exit, median follow-up 4.9 years (max. follow-up 8.1 years)

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Study Chair: Bruce Wilkoff, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): November 2, 2022
• Study Completion (Actual): November 2, 2022

Study Registration Dates

• First Submitted: July 18, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (Estimated): July 31, 2014

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: AdaptivCRT; aCRT
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Bundle-Branch Block
• Other Study ID Numbers: AdaptResponse