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AdaptResponse Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02205359
Recruitment Status : Active, not recruiting
First Posted : July 31, 2014
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Heart Failure With Left Bundle Branch Block Device: aCRT ON Device: aCRT OFF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: AdaptResponse Clinical Trial
Study Start Date : July 2014
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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

Active Comparator: aCRT OFF
Standard CRT
Device: aCRT OFF
CRT device with AdaptivCRT disabled




Primary Outcome Measures :
  1. Combined endpoint of all-cause mortality and intervention for heart failure decompensation [ Time Frame: 2 years post randomization ]
    Intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 2 years post randomization ]
  2. Percent of patients with interventions for heart failure decompensation [ Time Frame: 2 years post randomization ]
    Intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.

  3. Clinical Composite Score [ Time Frame: 6 months post randomization ]
    The Clinical Composite Score 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.

  4. Atrial fibrillation [ Time Frame: 2 years post randomization ]
    Incidence of atrial fibrillation lasting >6 hours in one day

  5. Change in Quality of Life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline to 2 years post randomization ]
    The overall summary score of the Kansas City Cardiomyopathy Questionnaire will be analyzed.

  6. Change in Quality of Life measured by the EQ-5D [ Time Frame: Baseline to 2 years post randomization ]
    The EQ-5D index score will be analyzed.

  7. All-cause re-admissions within 30-days after a heart failure admission [ Time Frame: 2 years post randomization ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205359


Locations
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United States, Arizona
CardioVascular Associates of Mesa
Mesa, Arizona, United States, 85206
Phoenix Cardiovascular Research Group, LLC
Phoenix, Arizona, United States, 85018-3956
United States, Arkansas
Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, United States, 72205-6202
United States, California
Scripps Green Hospital Scripps Clinic Torrey Pines
La Jolla, California, United States, 92037-1027
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048-5913
Coggins & Levy Medical Associates
San Jose, California, United States, 95124
Stanford Hospital & Clinics
Stanford, California, United States, 94305-2200
Saint Joseph's Medical Center
Stockton, California, United States, 95204
United States, Colorado
Penrose Hospital
Colorado Springs, Colorado, United States, 80907-6863
Medical Center of the Rockies
Loveland, Colorado, United States, 80528
United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06606-4284
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010-3017
United States, Florida
Heart & Vascular Institute of Florida
Clearwater, Florida, United States, 33756-3367
Florida Heart Rhythm Specialists PLLC
Fort Lauderdale, Florida, United States, 33308
The Cardiac & Vascular Institute
Gainesville, Florida, United States
First Coast Cardiovascular Institute PA
Jacksonville, Florida, United States, 32256-6954
Cardiovascular Research Center of South Florida
Miami, Florida, United States
Florida Hospital Cardiovascular Research Institute
Orlando, Florida, United States, 32803-1248
Cardiology Institute of Northwest Florida
Panama City, Florida, United States, 32401-3665
University of South Florida Health (USF)
Tampa, Florida, United States, 33606
United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308-2225
Piedmont Heart Institute
Atlanta, Georgia, United States
United States, Illinois
Northwerstern University
Chicago, Illinois, United States, 60611
Prairie Education and Research Cooperative
Springfield, Illinois, United States, 62769-0002
United States, Indiana
Saint Francis Medical Group Indiana Heart Physician
Indianapolis, Indiana, United States, 46237-6345
United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121-2429
United States, Maryland
MedStar Health Research Institute
Baltimore, Maryland, United States, 21237-3958
United States, Massachusetts
Massachusetts General Hospital (Boston MA)
Boston, Massachusetts, United States, 02114-2621
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-5853
Sparrow Clinical Research Institute
Lansing, Michigan, United States, 48912
William Beaumont Hospital
Troy, Michigan, United States, 48098-6375
Michigan Heart
Ypsilanti, Michigan, United States, 48197-8633
United States, Minnesota
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States, 55455
North Memorial Heart and Vascular Institute
Robbinsdale, Minnesota, United States, 55422-2926
United Heart and Vascular Clinic
Saint Paul, Minnesota, United States, 55102-2568
United States, Missouri
Mid America Heart Institute (MAHI)
Kansas City, Missouri, United States, 64132
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110-1010
United States, Montana
Glacier View Research Institute Cardiology
Kalispell, Montana, United States, 59901
United States, New Jersey
Lourdes Cardiology Services
Voorhees, New Jersey, United States, 08043-4322
United States, New Mexico
Presbyterian Heart Group
Albuquerque, New Mexico, United States, 87106-4921
United States, New York
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
United States, North Carolina
Asheville Cardiology Associate PA
Asheville, North Carolina, United States
Duke University Medical Center (DUMC)
Durham, North Carolina, United States, 27705
Carolina Cardiology Cornerstone
High Point, North Carolina, United States
Raleigh Cardiology Associates
Raleigh, North Carolina, United States
United States, Ohio
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, 43214
Mount Carmel East
Columbus, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
North Ohio Heart-Elyria
Elyria, Ohio, United States
United States, Oklahoma
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, United States
United States, Oregon
Sacred Heart Medical Center
Eugene, Oregon, United States
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Capital Area Research
Camp Hill, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17602
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, 18510
United States, South Carolina
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
United States, Tennessee
Sutherland Cardiology Clinic
Memphis, Tennessee, United States
Centennial Heart Cardiovascular Consultants LLC
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
United States, Texas
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, 75093
EP Heart LLC
The Woodlands, Texas, United States
Tyler Cardiovascular Consultants
Tyler, Texas, United States
United States, Utah
University of Utah
Salt Lake City, Utah, United States
United States, Vermont
The University of Vermont Medical Center Inc
Burlington, Vermont, United States
United States, Virginia
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
United States, Washington
Swedish Medical Center Cherry Hill
Seattle, Washington, United States
Providence Spokane Cardiology
Spokane, Washington, United States
United States, West Virginia
CAMC Health Education & Research Institute Inc
Charleston, West Virginia, United States
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53211
Aurora Cardiovascular Services
Milwaukee, Wisconsin, United States, 53215
Australia, New South Wales
John Hunter Hospital
New Lambton, New South Wales, Australia
Australia, Victoria
Austin Hospital
Heidelberg, Victoria, Australia
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Australia
Saint Vincent's Hospital (Sydney)
Sydney, Australia
Austria
Landeskrankenhaus Innsbruck - Universitätskliniken
Innsbruck, Austria
Allgemeines Krankenhaus der Stadt Linz
Linz, Austria
Belgium
Ziekenhuis Oost Limburg - Campus St.-Jan
Genk, Belgium
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)
Quebec, Canada
Royal Columbian Hospital
Vancouver, Canada
Vancouver General Hospital
Vancouver, Canada
Denmark
Odense Universitetshospital
Odense C, Denmark, 5000
Finland
Keski-Suomen Keskussairaala
Jyväskylä, Finland
Satakunnan keskussairaala
Pori, Finland
France
Centre Hospitalier Universitaire de Amiens - Hôpital SU
Amiens, France
CHRU Tours - Hôpital Trousseau
Chambray lès tours, France
CHRU La Rochelle
La Rochelle, France, 17019
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
Institut Hospitalier Jacques Cartier
Massy, France
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier Cedex 5, France
Nouvelles Cliniques Nantaises
Nantes, France
CMC-Clinique Ambroise Pare
Neuilly-sur-Seine, France
Hôpital Pontchaillou - CHU de Rennes
Rennes Cedex 9, France
CHU Toulouse - Hôpital Rangueil
Toulouse Cedex 9, France
Germany
Immanuel Diakonie Group - Evangelisch-Freikirchlichen Krankenhaus und Herzzentrum Brandenburg
Bernau bei Berlin, 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 Schleswig-Holstein - Campus Lübeck
Lübeck, Germany
Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid
Lüdenscheid, Germany, 58515
Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
Lüdenscheid, Germany
Otto von Guericke Universität - Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, Germany, 39120
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, 89801
Hungary
Semmelweis Egyetem AOK
Budapest, Hungary
India
Medanta - The Medicity
Gurgaon, India
Fortis Escorts Heart Institute
New Delhi, India
Max Devki Devi Heart and Vascular Institute
New Delhi, India
Italy
Policlinico Sant' Orsola - Malpighi
Bologna, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy
Azienda Ospedaliera Carlo Poma
Mantova, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Japan
Hirosaki University Hospital
Hirosaki, Aomori Prefecture, Japan
Chiba University Hospital
Chiba-Shi, Japan
Kokura Memorial Hospital
Kitakyushu, Japan
Kyorin University Hospital
Mitaka-Shi, Japan
Nagoya University Hospital
Nagoya, Japan
Sakakibara Heart Institute of Okayama
Okayama-Shi, 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
Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Yeungnam University Medical Center
Daegu, Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-Do, Korea, Republic of
Kyung Hee University Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Mexico
Hospital Angeles Leon
Leon, Guanajuato, Mexico
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Amphia Ziekenhuis - Locatie Molengracht Breda
Breda, Netherlands, 4818 CK
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Canisius-Wilhelmina ziekenhuis
Nijmegen, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands, 3078 HT
Erasmus Medisch Centrum
Rotterdam, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Isala Klinieken - Locatie Weezenlanden
Zwolle, Netherlands, 8011 JW
Norway
Helse Bergen HF - Haukeland Universitetssjukehus
Bergen, Norway
Portugal
Centro Hospitalar de Coimbra
Coimbra, Portugal, 3041-801
Hospital de Espírito Santo E.P.E.
Évora, Portugal, 7000
Puerto Rico
The Arrhythmia Group
Coto Laurel, Puerto Rico
Cardiovascular Center
San Juan, Puerto Rico
Saudi Arabia
King Abdul Aziz University 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
Slovakia
Stredoslovensky ustav srdcovych a cievnych chorob a.s
Banska Bystrica, Slovakia
NUSCH, a.s.
Bratislava 37, Slovakia, 83348
Spain
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
Sevilla, Spain
Complexo Hospitalario Universitario de Vigo - Hospital Xeral Cíes
Vigo, Spain
Sweden
Akademiska Sjukhuset
Uppsala, Sweden
Switzerland
Universitätsspital Basel
Basel, Switzerland, 4031
Kantonsspital St.Gallen
Saint Gallen, Switzerland
Taiwan
National Taiwan University Hospital Hsin Chu Branch
Hsinchu, Taiwan, 30059
National Taiwan University Hospital
Taipei, Taiwan
United Kingdom
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
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Study Chair: Bruce Wilkoff, MD The Cleveland Clinic
Study Director: David Steinhaus, MD Medtronic Cardiac Rhythm and Heart Failure

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02205359    
Other Study ID Numbers: AdaptResponse
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
AdaptivCRT
aCRT
Additional relevant MeSH terms:
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Bundle-Branch Block
Heart Diseases
Cardiovascular Diseases
Heart Block
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes