Heart Failure Clinical Trial

AdaptResponse Clinical Trial

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).

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Heart Failure

Estimated Enrollment:

3797

Study ID:

NCT02205359

Recruitment Status:

Completed

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 58 Locations for this study

See Locations Near You

CardioVascular Associates of Mesa
Mesa Arizona, 85206, United States
Phoenix Cardiovascular Research Group, LLC
Phoenix Arizona, 85018, United States
Saint Vincent Heart Clinic Arkansas
Little Rock Arkansas, 72205, United States
Scripps Green Hospital Scripps Clinic Torrey Pines
La Jolla California, 92037, United States
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
Coggins & Levy Medical Associates
San Jose California, 95124, United States
Stanford Hospital & Clinics
Stanford California, 94305, United States
Saint Joseph's Medical Center
Stockton California, 95204, United States
Penrose Hospital
Colorado Springs Colorado, 80907, United States
Medical Center of the Rockies
Loveland Colorado, 80528, United States
Bridgeport Hospital
Bridgeport Connecticut, 06606, United States
Washington Hospital Center
Washington District of Columbia, 20010, United States
Heart & Vascular Institute of Florida
Clearwater Florida, 33756, United States
Florida Heart Rhythm Specialists PLLC
Fort Lauderdale Florida, 33308, United States
The Cardiac & Vascular Institute
Gainesville Florida, , United States
First Coast Cardiovascular Institute PA
Jacksonville Florida, 32256, United States
Cardiovascular Research Center of South Florida
Miami Florida, , United States
AdventHealth Cardiovascular Research Institute
Orlando Florida, 32803, United States
Cardiology Institute of Northwest Florida
Panama City Florida, 32401, United States
University of South Florida Health (USF)
Tampa Florida, 33606, United States
Emory University Hospital Midtown
Atlanta Georgia, 30308, United States
Piedmont Heart Institute
Atlanta Georgia, , United States
Northwerstern University
Chicago Illinois, 60611, United States
Prairie Education and Research Cooperative
Springfield Illinois, 62769, United States
Saint Francis Medical Group Indiana Heart Physician
Indianapolis Indiana, 46237, United States
Ochsner Medical Center
New Orleans Louisiana, 70121, United States
MedStar Health Research Institute
Baltimore Maryland, 21237, United States
Massachusetts General Hospital (Boston MA)
Boston Massachusetts, 02114, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Sparrow Clinical Research Institute
Lansing Michigan, 48912, United States
William Beaumont Hospital
Troy Michigan, 48098, United States
Michigan Heart
Ypsilanti Michigan, 48197, United States
University of Minnesota Medical Center Fairview
Minneapolis Minnesota, 55455, United States
North Memorial Heart and Vascular Institute
Robbinsdale Minnesota, 55422, United States
United Heart and Vascular Clinic
Saint Paul Minnesota, 55102, United States
Mid America Heart Institute (MAHI)
Kansas City Missouri, 64132, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Glacier View Research Institute Cardiology
Kalispell Montana, 59901, United States
Lourdes Cardiology Services
Voorhees New Jersey, 08043, United States
Presbyterian Heart Group
Albuquerque New Mexico, 87106, 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, 27705, 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, 43214, 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, 17602, 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, 18510, 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, 75093, 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, 53211, United States
Aurora Cardiovascular Services
Milwaukee Wisconsin, 53215, 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
Brugge , , 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)
Quebec , , Canada
Royal Columbian Hospital
Vancouver , , Canada
Vancouver General Hospital
Vancouver , , Canada
Odense Universitetshospital
Odense C , 5000, 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 , 17019, 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 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
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 , 58515, Germany
Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
Lüdenscheid , , Germany
Otto von Guericke Universität - Universitätsklinikum Magdeburg A.ö.R.
Magdeburg , 39120, 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 , 89801, 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 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
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
Hospital Angeles Leon
Leon Guanajuato, , Mexico
Academisch Medisch Centrum
Amsterdam , 1105 , Netherlands
Amphia Ziekenhuis - Locatie Molengracht Breda
Breda , 4818 , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden , , Netherlands
Canisius-Wilhelmina ziekenhuis
Nijmegen , , Netherlands
Maasstad Ziekenhuis
Rotterdam , 3078 , Netherlands
Erasmus Medisch Centrum
Rotterdam , , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht , , Netherlands
Isala Klinieken - Locatie Weezenlanden
Zwolle , 8011 , 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 , 3041-, Portugal
Hospital de Espírito Santo E.P.E.
Évora , 7000, 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 , , Russian Federation
EN Meshalkin National medical research center of the Ministry of Health of the Russian Federation
Novosibirsk , , Russian Federation
Almazov National Medical Research Centre
St Petersburg , , Russian Federation
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
Banska Bystrica , , Slovakia
NUSCH, a.s.
Bratislava 37 , 83348, Slovakia
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
Hospital Universitario Miguel Servet
Zaragoza , , Spain
Karolinska Universitetssjukhuset
Solna , , Sweden
Akademiska Sjukhuset
Uppsala , , Sweden
Universitätsspital Basel
Basel , 4031, Switzerland
HFR Fribourg - Hôpital cantonal
Fribourg , , Switzerland
Kantonsspital St.Gallen
Saint Gallen , , Switzerland
National Taiwan University Hospital Hsin Chu Branch
Hsinchu , 30059, 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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

3797

Study ID:

NCT02205359

Recruitment Status:

Completed

Sponsor:


Medtronic Cardiac Rhythm and Heart Failure

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider