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AdaptResponse Clinical Trial

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ClinicalTrials.gov Identifier: NCT02205359
Recruitment Status : Recruiting
First Posted : July 31, 2014
Last Update Posted : August 20, 2018
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

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 2022
Estimated Study Completion Date : March 2023

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.


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


Contacts
Contact: AdaptResponse Trial Leader medtronicCRMtrials@medtronic.com

  Hide Study Locations
Locations
United States, Alabama
Baptist Medical Center South Withdrawn
Montgomery, Alabama, United States, 36116
United States, Arizona
CardioVascular Associates of Mesa Recruiting
Mesa, Arizona, United States, 85206
Phoenix Cardiovascular Research Group, LLC Recruiting
Phoenix, Arizona, United States, 85018-3956
Contact: Marwan Bahu         
United States, Arkansas
Saint Vincent Heart Clinic Arkansas Recruiting
Little Rock, Arkansas, United States, 72205-6202
Contact: Thomas Wallace         
United States, California
Scripps Green Hospital Scripps Clinic Torrey Pines Recruiting
La Jolla, California, United States, 92037-1027
Contact: Thomas Heywood, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048-5913
Contact: Donna Gallik         
Coggins & Levy Medical Associates Recruiting
San Jose, California, United States, 95124
Stanford Hospital & Clinics Recruiting
Stanford, California, United States, 94305-2200
Contact: Mohan Viswanathan         
Saint Joseph's Medical Center Recruiting
Stockton, California, United States, 95204
Contact: Chien Walter         
Principal Investigator: Chien Walter         
United States, Colorado
Penrose Hospital Recruiting
Colorado Springs, Colorado, United States, 80907-6863
Contact: Christopher Cole         
Medical Center of the Rockies Recruiting
Loveland, Colorado, United States, 80528
Contact: Rob Kiser         
United States, Connecticut
Bridgeport Hospital Recruiting
Bridgeport, Connecticut, United States, 06606-4284
Contact: Adam Lottick         
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010-3017
Contact: Susan O'Donoghue         
United States, Florida
Heart & Vascular Institute of Florida Recruiting
Clearwater, Florida, United States, 33756-3367
Contact: Jonathan Hobson         
Florida Heart Rhythm Specialists PLLC Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Osman Ahmed         
The Cardiac & Vascular Institute Recruiting
Gainesville, Florida, United States
Contact: Timothy Wessel         
First Coast Cardiovascular Institute PA Recruiting
Jacksonville, Florida, United States, 32256-6954
Contact: Satish Goel         
Cardiovascular Research Center of South Florida Recruiting
Miami, Florida, United States
Contact: Efrain Gonzalez         
Florida Hospital Cardiovascular Research Institute Recruiting
Orlando, Florida, United States, 32803-1248
Contact: George Monir         
Cardiology Institute of Northwest Florida Recruiting
Panama City, Florida, United States, 32401-3665
Contact: Hari Baddigam         
University of South Florida Health (USF) Recruiting
Tampa, Florida, United States, 33606
Contact: Bengt Herweg         
United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308-2225
Contact: Angel Leon         
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States
Contact: Stephen Prater         
United States, Illinois
Northwerstern University Recruiting
Chicago, Illinois, United States, 60611
Rockford Cardiovascular Associates Withdrawn
Rockford, Illinois, United States, 61107-5059
Prairie Education and Research Cooperative Recruiting
Springfield, Illinois, United States, 62769-0002
Contact: Ziad Issa         
United States, Indiana
Saint Francis Medical Group Indiana Heart Physician Recruiting
Indianapolis, Indiana, United States, 46237-6345
Contact: Smriti Banthia         
United States, Kansas
Midwest Heart & Vascular Withdrawn
Overland Park, Kansas, United States, 64132
United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121-2429
Contact: Glenn Polin         
United States, Maryland
MedStar Health Research Institute Recruiting
Baltimore, Maryland, United States, 21237-3958
Contact: Glenn Meininger         
United States, Massachusetts
Massachusetts General Hospital (Boston MA) Recruiting
Boston, Massachusetts, United States, 02114-2621
Contact: Theofanie Mela         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109-5853
Contact: Thomas Crawford         
Sparrow Clinical Research Institute Recruiting
Lansing, Michigan, United States, 48912
Contact: David Rhine         
William Beaumont Hospital Recruiting
Troy, Michigan, United States, 48098-6375
Contact: Brian Williamson         
Michigan Heart Recruiting
Ypsilanti, Michigan, United States, 48197-8633
Contact: Timothy Shinn         
United States, Minnesota
University of Minnesota Medical Center Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Henri Roukoz         
North Memorial Heart and Vascular Institute Recruiting
Robbinsdale, Minnesota, United States, 55422-2926
Contact: Douglas Hodgkin         
United Heart and Vascular Clinic Recruiting
Saint Paul, Minnesota, United States, 55102-2568
Contact: Alan Bank         
United States, Missouri
Mid America Heart Institute (MAHI) Recruiting
Kansas City, Missouri, United States, 64132
Contact: Brian Ramza         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110-1010
Contact: Marye Gleva         
Missouri Baptist Medical Center Withdrawn
Saint Louis, Missouri, United States
United States, Montana
Glacier View Research Institute Cardiology Recruiting
Kalispell, Montana, United States, 59901
Contact: Ilyas Colombowala         
United States, New Jersey
Lourdes Cardiology Services Recruiting
Voorhees, New Jersey, United States, 08043-4322
Contact: Devender Akula         
United States, New Mexico
Presbyterian Heart Group Recruiting
Albuquerque, New Mexico, United States, 87106-4921
Contact: Lawrence Nair         
United States, New York
New York Methodist Hospital Recruiting
Brooklyn, New York, United States
Contact: Gioia Turitto         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States
Contact: Jacob Koruth         
NYU Langone Medical Center Recruiting
New York, New York, United States
Contact: Charles Love         
Weill Medical College of Cornell University Recruiting
New York, New York, United States
Contact: Chris Liu         
Hudson Valley Heart Center Recruiting
Poughkeepsie, New York, United States
Contact: Sankar Varanasi         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States
Contact: Eric Rashba         
Central New York Cardiology Recruiting
Utica, New York, United States
Contact: Thor Markwood         
United States, North Carolina
Asheville Cardiology Associate PA Recruiting
Asheville, North Carolina, United States
Contact: Joseph Souza         
Duke University Medical Center (DUMC) Recruiting
Durham, North Carolina, United States, 27705
Contact: Jason Koontz         
Carolina Cardiology Cornerstone Recruiting
High Point, North Carolina, United States
Contact: David Fitzgerald         
Raleigh Cardiology Associates Recruiting
Raleigh, North Carolina, United States
Contact: Marc Silver         
United States, Ohio
Bethesda North Hospital Recruiting
Cincinnati, Ohio, United States
Contact: Gaurang Gandhi         
The Lindner Research Center Recruiting
Cincinnati, Ohio, United States
Contact: Eugene Chung         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States
Contact: Niraj Varma         
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States
Contact: Judith Mackall         
OhioHealth Research Institute Recruiting
Columbus, Ohio, United States, 43214
Mount Carmel East Recruiting
Columbus, Ohio, United States
Contact: Joshua Silverstein         
The Ohio State University Recruiting
Columbus, Ohio, United States
Contact: Mahmoud Houmsse         
North Ohio Heart-Elyria Recruiting
Elyria, Ohio, United States
Contact: Kara Quan         
United States, Oklahoma
Oklahoma Heart Hospital Research Foundation Recruiting
Oklahoma City, Oklahoma, United States
Contact: Charles Te         
United States, Oregon
Sacred Heart Medical Center Recruiting
Eugene, Oregon, United States
Contact: Ramakota Reddy         
United States, Pennsylvania
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States
Contact: Gregory Altemose         
Capital Area Research Recruiting
Camp Hill, Pennsylvania, United States
Contact: Venkatesh Nadar         
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17602
Contact: Sandeep Bansal         
Mercer Bucks Cardiology Recruiting
Newtown, Pennsylvania, United States
Contact: Scott Burke         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States
Contact: Daniel Frisch         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States
Contact: David Frankel, MD         
Principal Investigator: David Frankel, MD         
University of Pittsburgh Medical Center UPMC Presbyterian Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Evan Adelstein         
Great Valley Cardiology Recruiting
Scranton, Pennsylvania, United States, 18510
Contact: Vitaly Geyfman         
United States, South Carolina
Medical University of South Carolina (MUSC) Recruiting
Charleston, South Carolina, United States
Contact: Michael Gold         
Principal Investigator: Frank Cuoco         
United States, Tennessee
Diagnostic Cardiology Group Withdrawn
Chattanooga, Tennessee, United States
Sutherland Cardiology Clinic Enrolling by invitation
Memphis, Tennessee, United States
Centennial Heart Cardiovascular Consultants LLC Recruiting
Nashville, Tennessee, United States
Contact: Peter Borek         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States
Contact: Dan Lenihan         
United States, Texas
Texas Cardiac Arrhythmia Research Recruiting
Austin, Texas, United States
Contact: Robert Canby         
The University of Texas (UT) Southwestern Medical Center Recruiting
Dallas, Texas, United States
Contact: James Daniels         
CHI St. Luke's Heath Baylor College of Medicine Medical Center Recruiting
Houston, Texas, United States
Contact: John Seger         
Houston Arrhythmia Associates PA Withdrawn
Houston, Texas, United States
Houston Methodist Hospital Withdrawn
Houston, Texas, United States
Baylor Research Institute Recruiting
Plano, Texas, United States, 75093
Contact: Hafiza Khan         
EP Heart LLC Enrolling by invitation
The Woodlands, Texas, United States
Tyler Cardiovascular Consultants Recruiting
Tyler, Texas, United States
Contact: Raul Torres         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States
Contact: Roger Freedman         
United States, Vermont
The University of Vermont Medical Center Inc Recruiting
Burlington, Vermont, United States
Contact: Joseph Winget         
United States, Virginia
University of Virginia Medical Center Recruiting
Charlottesville, Virginia, United States
Contact: Kenneth Bilchick         
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States
Contact: Allen Ciuffo         
Principal Investigator: Jon Grammes         
Virginia Cardiovascular Specialists PC Recruiting
Richmond, Virginia, United States
Contact: Robert Sperry         
Virginia Commonwealth University Health System Recruiting
Richmond, Virginia, United States
Contact: Kenneth Ellenbogen         
Principal Investigator: Richard Shepard         
United States, Washington
Swedish Medical Center Cherry Hill Recruiting
Seattle, Washington, United States
Contact: Darryl Wells         
Providence Spokane Cardiology Active, not recruiting
Spokane, Washington, United States
United States, West Virginia
CAMC Health Education & Research Institute Inc Recruiting
Charleston, West Virginia, United States
Contact: Brett Faulknier         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53211
Aurora Cardiovascular Services Recruiting
Milwaukee, Wisconsin, United States, 53215
Principal Investigator: Atul Bhatia         
Australia, New South Wales
John Hunter Hospital Recruiting
New Lambton, New South Wales, Australia
Contact: Malcolm Barlow         
Australia, Victoria
Austin Hospital Recruiting
Heidelberg, Victoria, Australia
Contact: David O'Donnell         
Australia, Western Australia
Fiona Stanley Hospital Recruiting
Murdoch, Western Australia, Australia
Contact: Timothy Gattorna         
Australia
Saint Vincent's Hospital (Sydney) Recruiting
Sydney, Australia
Contact: Christopher S.H. Hayward         
Austria
Landeskrankenhaus Innsbruck - Universitätskliniken Recruiting
Innsbruck, Austria
Contact: Wolfgang Dichtl         
Allgemeines Krankenhaus der Stadt Linz Recruiting
Linz, Austria
Contact: Clemens Steinwender         
Belgium
Ziekenhuis Oost Limburg - Campus St.-Jan Recruiting
Genk, Belgium
Contact: Wilfried Mullens         
Canada
McGill Universtiy Health Centre (MUHC) Recruiting
Montreal, Canada
Contact: Vidal Essebag         
Southlake Regional Health Centre Recruiting
Newmarket, Canada
Contact: Yaariv Khaykin         
University of Ottawa Heart Institute Recruiting
Ottawa, Canada
Contact: David Birnie         
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) Recruiting
Quebec, Canada
Contact: Francois Philippon         
Royal Columbian Hospital Recruiting
Vancouver, Canada
Contact: Stanley Tung         
Vancouver General Hospital Recruiting
Vancouver, Canada
Contact: Matt Bennett         
Denmark
Odense Universitetshospital Recruiting
Odense C, Denmark, 5000
Aarhus Universitetshospital - Skejby Withdrawn
Århus N, Denmark
Finland
Keski-Suomen Keskussairaala Recruiting
Jyväskylä, Finland
Contact: Kai Nyman         
Satakunnan keskussairaala Recruiting
Pori, Finland
Contact: Pasi P. Karjalainen         
France
Centre Hospitalier Universitaire de Amiens - Hôpital SU Recruiting
Amiens, France
Contact: Jean Sylvain Hermida         
CHRU Tours - Hôpital Trousseau Recruiting
Chambray lès tours, France
Contact: Bertrand Pierre         
CHRU La Rochelle Recruiting
La Rochelle, France, 17019
Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon Recruiting
La Tronche, France
Contact: Pascal Defaye         
CHRU de Lille Recruiting
Lille, France
Contact: Laurence Guedon-Moreau         
groupe Hospitalier de L'Institut Catholique de Lille - Hôpital Saint-Philibert Recruiting
Lomme, France
Contact: Yves Guyomar         
Institut Hospitalier Jacques Cartier Recruiting
Massy, France
Contact: Fiorella Salerno         
CHRU de Montpellier - Hôpital Arnaud de Villeneuve Recruiting
Montpellier Cedex 5, France
Contact: Jean Marc Davy         
Nouvelles Cliniques Nantaises Recruiting
Nantes, France
Contact: Daniel Gras         
Principal Investigator: Jean-Pierre Cebron         
CMC-Clinique Ambroise Pare Recruiting
Neuilly-sur-Seine, France
Contact: Christine Alonso         
Hôpital Pontchaillou - CHU de Rennes Recruiting
Rennes Cedex 9, France
Contact: Christophe Leclercq         
CHU Toulouse - Hôpital Rangueil Recruiting
Toulouse Cedex 9, France
Contact: Pierre Mondoly         
Germany
Immanuel Diakonie Group - Evangelisch-Freikirchlichen Krankenhaus und Herzzentrum Brandenburg Recruiting
Bernau bei Berlin, Germany
Contact: Christian Butter         
Klinikum Coburg GmbH Recruiting
Coburg, Germany
Contact: Johannes Brachmann         
Praxisklinik Herz und Gefässe - Akademische Lehrpraxisklinik der TU Dresden Recruiting
Dresden, Germany
Contact: Stefan G Spitzer         
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany
Contact: Dong-In Shin         
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany
Contact: Edgar Zitron         
Universitätskliniken des Saarlandes Recruiting
Homburg/Saar, Germany
Contact: Christian Ukena         
Universitätsklinikum Schleswig-Holstein - Campus Lübeck Recruiting
Lübeck, Germany
Contact: Frank Bode         
Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid Recruiting
Lüdenscheid, Germany, 58515
Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH Recruiting
Lüdenscheid, Germany
Contact: Axel Kloppe         
Otto von Guericke Universität - Universitätsklinikum Magdeburg A.ö.R. Recruiting
Magdeburg, Germany, 39120
Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus Recruiting
Mönchengladbach, Germany
Contact: Istvan Szendey         
Klinikum der Universität München - Campus Großhadern Recruiting
München, Germany
Contact: Stephanie Fichtner         
Herz Riesa, Gemeinschaftspraxis Recruiting
Riesa, Germany
Contact: Hans-Holger Ebert         
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89801
Hungary
Semmelweis Egyetem AOK Recruiting
Budapest, Hungary
Contact: Bela Merkely         
India
Medanta - The Medicity Recruiting
Gurgaon, India
Contact: Balbir Singh         
Fortis Escorts Heart Institute Recruiting
New Delhi, India
Contact: Anil Saxena         
Max Devki Devi Heart and Vascular Institute Recruiting
New Delhi, India
Contact: Vanita Arora         
Italy
Policlinico Sant' Orsola - Malpighi Recruiting
Bologna, Italy
Contact: Igor Diemberger         
Azienda Ospedaliera Spedali Civili di Brescia Recruiting
Brescia, Italy
Contact: Antonio Curnis         
Azienda Ospedaliera Carlo Poma Recruiting
Mantova, Italy
Contact: Albino Reggiani         
Azienda Ospedaliera Universitaria Integrata Verona Recruiting
Verona, Italy
Contact: Giovanni Morani         
Japan
Hirosaki University Hospital Recruiting
Hirosaki, Aomori Prefecture, Japan
Contact: Shingo Sasaki         
Chiba University Hospital Recruiting
Chiba-Shi, Japan
Contact: Marehiko Ueda         
Kameda Medical Center Withdrawn
Kamogawa-Shi, Japan
Kokura Memorial Hospital Recruiting
Kitakyushu, Japan
Contact: Kenji Ando         
Kyorin University Hospital Recruiting
Mitaka-Shi, Japan
Contact: Kyoko Soejima         
Nagoya University Hospital Recruiting
Nagoya, Japan
Contact: Yasuya Inden         
Sakakibara Heart Institute of Okayama Terminated
Okayama-Shi, Japan
Tohoku University Hospital Withdrawn
Sendai-Shi, Japan
Saitama Medical Center Jichi Medical University Recruiting
Shimonoseki-Shi, Japan
Contact: Takeshi Mitsuhashi         
National Cerebral and Cardiovascular Center Recruiting
Suita-Shi, Japan
Contact: Kengo Kusano         
Fujita Health University Hospital Recruiting
Toyoake, Japan
Contact: Eiichi Watanabe         
University of Fukui Hospital Recruiting
Tsukuba, Japan
Contact: Hiroshi Tada         
Korea, Republic of
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Hyoung-Seob Park         
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Dong-Gu Shin         
Seoul National University Bundang Hospital Recruiting
Gyeonggi-Do, Korea, Republic of
Contact: Il-Young Oh         
Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jin-Bae Kim         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-Jung Park         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Se-ll Oh         
Mexico
Hospital Angeles Leon Recruiting
Leon, Guanajuato, Mexico
Contact: susano Lara Vaca         
Netherlands
Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Joris Rogier de Groot         
Amphia Ziekenhuis - Locatie Molengracht Breda Recruiting
Breda, Netherlands, 4818 CK
Contact: Antonio Marco Willem Alings         
Medisch Centrum Leeuwarden Recruiting
Leeuwarden, Netherlands
Contact: Margriet Feenema-Aardema         
Canisius-Wilhelmina ziekenhuis Recruiting
Nijmegen, Netherlands
Contact: Erwin Sebastiaan Zegers         
Maasstad Ziekenhuis Recruiting
Rotterdam, Netherlands, 3078 HT
Contact: B.K. Dijkman         
Erasmus Medisch Centrum Recruiting
Rotterdam, Netherlands
Contact: Tamas Szili-Torok         
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands
Contact: Darryl Wells         
Isala Klinieken - Locatie Weezenlanden Recruiting
Zwolle, Netherlands, 8011 JW
Contact: Peter Paul Henri Marie Delnoy         
Norway
Helse Bergen HF - Haukeland Universitetssjukehus Recruiting
Bergen, Norway
Contact: Svein Faerestrand         
Portugal
Centro Hospitalar de Coimbra Recruiting
Coimbra, Portugal, 3041-801
Hospital de Espírito Santo E.P.E. Recruiting
Évora, Portugal, 7000
Puerto Rico
The Arrhythmia Group Recruiting
Coto Laurel, Puerto Rico
Contact: Francisco Perez-Gil         
Cardiovascular Center Recruiting
San Juan, Puerto Rico
Contact: Juan Sotomonte         
Saudi Arabia
King Abdul Aziz University Hospital Recruiting
Jeddah, Saudi Arabia
Contact: Naeem Al Shoaibi         
King Faisal Specialist Hospital & Research Center Recruiting
Riyadh, Saudi Arabia
Contact: Azam Shafquat         
The College of Medicine & King Khalid University Hospital, King Saud University Recruiting
Riyadh, Saudi Arabia
Contact: Ahmad Hersi         
Slovakia
Stredoslovensky ustav srdcovych a cievnych chorob a.s Recruiting
Banska Bystrica, Slovakia
Contact: Gabriela Kaliska         
NUSCH, a.s. Recruiting
Bratislava 37, Slovakia, 83348
Spain
Hospital Universitario Infanta Cristina Recruiting
Badajoz, Spain
Contact: Joaquin Fernández de la Concha-Castañeda         
Nuevo Hospital de Burgos Recruiting
Burgos, Spain
Contact: Javier Garcia Fernandez         
Hospital Virgen de la Arrixaca Recruiting
El Palmar, Spain
Contact: Arcadio García Alberola         
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain
Contact: Luis Tercedor         
Hospital Clínico Virgen de la Victoria Recruiting
Málaga, Spain
Contact: Francisco Javier Alzueta         
Hospital Clinico Universitario de Salamanca Recruiting
Salamanca, Spain
Contact: Jimenez Candil         
Hospital Universitario Nuestra Señora de Candelaria Recruiting
Santa Cruz de Tenerife, Spain
Contact: Rafael romero Garrido         
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain
Contact: Alonso Pedrote Martinez         
Complexo Hospitalario Universitario de Vigo - Hospital Xeral Cíes Recruiting
Vigo, Spain
Contact: Enrique Garcia Campo         
Sweden
Sahlgrenska Universitetssjukhuset Withdrawn
Göteborg, Sweden
Akademiska Sjukhuset Recruiting
Uppsala, Sweden
Contact: Carina Blomström-Lundqvist         
Switzerland
Universitätsspital Basel Recruiting
Basel, Switzerland, 4031
Kantonsspital St.Gallen Recruiting
Saint Gallen, Switzerland
Contact: Peter Ammann         
Taiwan
National Taiwan University Hospital Hsin Chu Branch Recruiting
Hsinchu, Taiwan, 30059
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Jiunn-Lee Lin         
United Kingdom
Golden Jubilee National Hospital - NHS Trust Recruiting
Glasgow, United Kingdom
Contact: Roy Gardner         
Liverpool Heart and Chest Hospital NHS Foundation Trust Recruiting
Liverpool, United Kingdom
Contact: Archana Rao         
University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital Recruiting
Liverpool, United Kingdom
Contact: Ashish Patwala         
Royal Brompton & Harefield NHS Foundation Trust - Royal Brompton Hospital Recruiting
London, United Kingdom
Contact: Rakesh Sharma         
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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):
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02205359     History of Changes
Other Study ID Numbers: AdaptResponse
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
AdaptivCRT
aCRT

Additional relevant MeSH terms:
Heart Failure
Bundle-Branch Block
Heart Diseases
Cardiovascular Diseases
Heart Block
Arrhythmias, Cardiac
Pathologic Processes