AdaptResponse Clinical Trial | NCT02205359 | Trialant

AdaptResponse Clinical Trial | NCT02205359 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

CardioVascular Associates of Mesa

Mesa, Arizona 85206, United States

Phoenix Cardiovascular Research Group, LLC

Phoenix, Arizona 85018-3956, United States

Saint Vincent Heart Clinic Arkansas

Little Rock, Arkansas 72205-6202, United States

Scripps Green Hospital Scripps Clinic Torrey Pines

La Jolla, California 92037-1027, United States

Cedars-Sinai Medical Center

Los Angeles, California 90048-5913, United States

Coggins & Levy Medical Associates

San Jose, California 95124, United States

Stanford Hospital & Clinics

Stanford, California 94305-2200, United States

Saint Joseph's Medical Center

Stockton, California 95204, United States

Penrose Hospital

Colorado Springs, Colorado 80907-6863, United States

Medical Center of the Rockies

Loveland, Colorado 80528, United States

Bridgeport Hospital

Bridgeport, Connecticut 06606-4284, United States

Washington Hospital Center

Washington D.C., District of Columbia 20010-3017, United States

Heart & Vascular Institute of Florida

Clearwater, Florida 33756-3367, 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 32256-6954, United States

Cardiovascular Research Center of South Florida

Miami, Florida, United States

AdventHealth Cardiovascular Research Institute

Orlando, Florida 32803-1248, United States

Cardiology Institute of Northwest Florida

Panama City, Florida 32401-3665, United States

University of South Florida Health (USF)

Tampa, Florida 33606, United States

Emory University Hospital Midtown

Atlanta, Georgia 30308-2225, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Northwerstern University

Chicago, Illinois 60611, United States

Prairie Education and Research Cooperative

Springfield, Illinois 62769-0002, United States

Saint Francis Medical Group Indiana Heart Physician

Indianapolis, Indiana 46237-6345, United States

Ochsner Medical Center

New Orleans, Louisiana 70121-2429, United States

MedStar Health Research Institute

Baltimore, Maryland 21237-3958, United States

Massachusetts General Hospital (Boston MA)

Boston, Massachusetts 02114-2621, United States

University of Michigan

Ann Arbor, Michigan 48109-5853, United States

Sparrow Clinical Research Institute

Lansing, Michigan 48912, United States

William Beaumont Hospital

Troy, Michigan 48098-6375, United States

Michigan Heart

Ypsilanti, Michigan 48197-8633, United States

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota 55455, United States

North Memorial Heart and Vascular Institute

Robbinsdale, Minnesota 55422-2926, United States

United Heart and Vascular Clinic

Saint Paul, Minnesota 55102-2568, United States

Mid America Heart Institute (MAHI)

Kansas City, Missouri 64132, United States

Washington University School of Medicine

St Louis, Missouri 63110-1010, United States

Glacier View Research Institute Cardiology

Kalispell, Montana 59901, United States

Lourdes Cardiology Services

Voorhees Township, New Jersey 08043-4322, United States

Presbyterian Heart Group

Albuquerque, New Mexico 87106-4921, 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

Bruges, Belgium

Ziekenhuis Oost Limburg - Campus St.-Jan

Genk, Belgium

London Health Sciences Centre - University Campus

London, Canada

McGill Universtiy Health Centre (MUHC)

Montreal, Canada

Southlake Regional Health Centre

Newmarket, Canada

University of Ottawa Heart Institute

Ottawa, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, Canada

Royal Columbian Hospital

Vancouver, Canada

Vancouver General Hospital

Vancouver, Canada

Odense Universitetshospital

Odense C, 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, France

Nouvelles Cliniques Nantaises

Nantes, France

CMC-Clinique Ambroise Pare

Neuilly-sur-Seine, France

Hôpital Pontchaillou - CHU de Rennes

Rennes, France

CHU Toulouse - Hôpital Rangueil

Toulouse, France

Immanuel Diakonie Group - Evangelisch-Freikirchlichen Krankenhaus und Herzzentrum Brandenburg

Bernau bei Berlin, Germany

Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

Bochum, Germany

MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz

Chemnitz, Germany

Klinikum Coburg GmbH

Coburg, Germany

Praxisklinik Herz und Gefässe - Akademische Lehrpraxisklinik der TU Dresden

Dresden, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Universitätskliniken des Saarlandes

Homburg/Saar, Germany

Universitätsklinikum Jena - Friedrich Schiller Universität

Jena, Germany

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Germany

Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid

Lüdenscheid, 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

Mantua, Italy

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Hirosaki University Hospital

Hirosaki, Aomori, Japan

Chiba University Hospital

Chiba, Japan

Kokura Memorial Hospital

Kitakyushu, Japan

Kyorin University Hospital

Mitaka-Shi, Japan

Nagoya University Hospital

Nagoya, Japan

Sakakibara Heart Institute of Okayama

Okayama, Japan

Saitama Medical Center Jichi Medical University

Shimonoseki-Shi, Japan

National Cerebral and Cardiovascular Center

Suita-Shi, Japan

Fujita Health University Hospital

Toyoake, Japan

University of Fukui Hospital

Tsukuba, Japan

Hospital Angeles Leon

León, Guanajuato, Mexico

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Amphia Ziekenhuis - Locatie Molengracht Breda

Breda, 4818 CK, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Canisius-Wilhelmina ziekenhuis

Nijmegen, Netherlands

Maasstad Ziekenhuis

Rotterdam, 3078 HT, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Isala Klinieken - Locatie Weezenlanden

Zwolle, 8011 JW, 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, 3041-801, Portugal

Hospital de Espírito Santo E.P.E.

Evora, 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, Russia

EN Meshalkin National medical research center of the Ministry of Health of the Russian Federation

Novosibirsk, Russia

Almazov National Medical Research Centre

Saint Petersburg, Russia

King Abdul Aziz University Hospital

Jeddah, Saudi Arabia

King Fahad Armed Forces Hospital

Jeddah, Saudi Arabia

King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia

The College of Medicine & King Khalid University Hospital, King Saud University

Riyadh, Saudi Arabia

Stredoslovensky ustav srdcovych a cievnych chorob a.s

Banská Bystrica, Slovakia

NUSCH, a.s.

Bratislava, 83348, Slovakia

Keimyung University Dongsan Medical Center

Daegu, South Korea

Yeungnam University Medical Center

Daegu, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Kyung Hee University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Hospital Universitario Infanta Cristina

Badajoz, Spain

Nuevo Hospital de Burgos

Burgos, Spain

Hospital Virgen de la Arrixaca

El Palmar, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Hospital Clínico Virgen de la Victoria

Málaga, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Complexo Hospitalario Universitario de Vigo - Hospital Xeral Cíes

Vigo, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Karolinska Universitetssjukhuset

Solna, Sweden

Akademiska Sjukhuset

Uppsala, Sweden

Universitätsspital Basel

Basel, 4031, Switzerland

HFR Fribourg - Hôpital cantonal

Fribourg, Switzerland

Kantonsspital St.Gallen

Sankt 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