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).
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.
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There are 58 Locations for this study
Mesa Arizona, 85206, United States
Phoenix Arizona, 85018, United States
Little Rock Arkansas, 72205, United States
La Jolla California, 92037, United States
Los Angeles California, 90048, United States
San Jose California, 95124, United States
Stanford California, 94305, United States
Stockton California, 95204, United States
Colorado Springs Colorado, 80907, United States
Loveland Colorado, 80528, United States
Bridgeport Connecticut, 06606, United States
Washington District of Columbia, 20010, United States
Clearwater Florida, 33756, United States
Fort Lauderdale Florida, 33308, United States
Gainesville Florida, , United States
Jacksonville Florida, 32256, United States
Miami Florida, , United States
Orlando Florida, 32803, United States
Panama City Florida, 32401, United States
Tampa Florida, 33606, United States
Atlanta Georgia, 30308, United States
Atlanta Georgia, , United States
Chicago Illinois, 60611, United States
Springfield Illinois, 62769, United States
Indianapolis Indiana, 46237, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21237, United States
Boston Massachusetts, 02114, United States
Ann Arbor Michigan, 48109, United States
Lansing Michigan, 48912, United States
Troy Michigan, 48098, United States
Ypsilanti Michigan, 48197, United States
Minneapolis Minnesota, 55455, United States
Robbinsdale Minnesota, 55422, United States
Saint Paul Minnesota, 55102, United States
Kansas City Missouri, 64132, United States
Saint Louis Missouri, 63110, United States
Kalispell Montana, 59901, United States
Voorhees New Jersey, 08043, United States
Albuquerque New Mexico, 87106, United States
Brooklyn New York, , United States
New York New York, , United States
New York New York, , United States
New York New York, , United States
Poughkeepsie New York, , United States
Stony Brook New York, , United States
Utica New York, , United States
Asheville North Carolina, , United States
Durham North Carolina, 27705, United States
High Point North Carolina, , United States
Raleigh North Carolina, , United States
Cincinnati Ohio, , United States
Cincinnati Ohio, , United States
Cleveland Ohio, , United States
Cleveland Ohio, , United States
Columbus Ohio, 43214, United States
Columbus Ohio, , United States
Columbus Ohio, , United States
Elyria Ohio, , United States
Oklahoma City Oklahoma, , United States
Eugene Oregon, , United States
Allentown Pennsylvania, , United States
Camp Hill Pennsylvania, , United States
Lancaster Pennsylvania, 17602, United States
Newtown Pennsylvania, , United States
Philadelphia Pennsylvania, , United States
Philadelphia Pennsylvania, , United States
Pittsburgh Pennsylvania, , United States
Scranton Pennsylvania, 18510, United States
Charleston South Carolina, , United States
Memphis Tennessee, , United States
Nashville Tennessee, , United States
Nashville Tennessee, , United States
Austin Texas, , United States
Dallas Texas, , United States
Houston Texas, , United States
Plano Texas, 75093, United States
The Woodlands Texas, , United States
Tyler Texas, , United States
Salt Lake City Utah, , United States
Burlington Vermont, , United States
Charlottesville Virginia, , United States
Norfolk Virginia, , United States
Richmond Virginia, , United States
Richmond Virginia, , United States
Seattle Washington, , United States
Spokane Washington, , United States
Charleston West Virginia, , United States
Milwaukee Wisconsin, 53211, United States
Milwaukee Wisconsin, 53215, United States
New Lambton New South Wales, , Australia
Heidelberg Victoria, , Australia
Murdoch Western Australia, , Australia
Sydney , , Australia
Innsbruck , , Austria
Linz , , Austria
Brugge , , Belgium
Genk , , Belgium
London , , Canada
Montreal , , Canada
Newmarket , , Canada
Ottawa , , Canada
Quebec , , Canada
Vancouver , , Canada
Vancouver , , Canada
Odense C , 5000, Denmark
Jyväskylä , , Finland
Pori , , Finland
Amiens , , France
Chambray lès tours , , France
Clermont-Ferrand , , France
Corbeil-Essonnes , , France
La Rochelle , 17019, France
La Tronche , , France
Lille , , France
Lomme , , France
Marseille , , France
Marseille , , France
Massy , , France
Metz , , France
Montpellier Cedex 5 , , France
Nantes , , France
Neuilly-sur-Seine , , France
Rennes Cedex 9 , , France
Toulouse Cedex 9 , , France
Bernau bei Berlin , , Germany
Bochum , , Germany
Chemnitz , , Germany
Coburg , , Germany
Dresden , , Germany
Düsseldorf , , Germany
Heidelberg , , Germany
Homburg/Saar , , Germany
Jena , , Germany
Lübeck , , Germany
Lüdenscheid , 58515, Germany
Lüdenscheid , , Germany
Magdeburg , 39120, Germany
Mönchengladbach , , Germany
München , , Germany
Riesa , , Germany
Ulm , 89801, Germany
Budapest , , Hungary
Budapest , , Hungary
Gurgaon , , India
New Delhi , , India
Bologna , , Italy
Brescia , , Italy
Chioggia , , Italy
Mantova , , Italy
Parma , , Italy
Verona , , Italy
Hirosaki Aomori Prefecture, , Japan
Chiba-Shi , , Japan
Kitakyushu , , Japan
Mitaka-Shi , , Japan
Nagoya , , Japan
Okayama-Shi , , Japan
Shimonoseki-Shi , , Japan
Suita-Shi , , Japan
Toyoake , , Japan
Tsukuba , , Japan
Daegu , , Korea, Republic of
Daegu , , Korea, Republic of
Gyeonggi-Do , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Leon Guanajuato, , Mexico
Amsterdam , 1105 , Netherlands
Breda , 4818 , Netherlands
Leeuwarden , , Netherlands
Nijmegen , , Netherlands
Rotterdam , 3078 , Netherlands
Rotterdam , , Netherlands
Utrecht , , Netherlands
Zwolle , 8011 , Netherlands
Bergen , , Norway
Kalisz , , Poland
Katowice , , Poland
Kielce , , Poland
Lublin , , Poland
Rzeszów , , Poland
Zabrze , , Poland
Beja , , Portugal
Coimbra , 3041-, Portugal
Évora , 7000, Portugal
Coto Laurel , , Puerto Rico
San Juan , , Puerto Rico
Moscow , , Russian Federation
Novosibirsk , , Russian Federation
St Petersburg , , Russian Federation
Jeddah , , Saudi Arabia
Jeddah , , Saudi Arabia
Riyadh , , Saudi Arabia
Riyadh , , Saudi Arabia
Banska Bystrica , , Slovakia
Bratislava 37 , 83348, Slovakia
Badajoz , , Spain
Burgos , , Spain
El Palmar , , Spain
Granada , , Spain
Málaga , , Spain
Salamanca , , Spain
Santa Cruz de Tenerife , , Spain
Sevilla , , Spain
Vigo , , Spain
Zaragoza , , Spain
Solna , , Sweden
Uppsala , , Sweden
Basel , 4031, Switzerland
Fribourg , , Switzerland
Saint Gallen , , Switzerland
Hsinchu , 30059, Taiwan
Taipei , , Taiwan
Glasgow , , United Kingdom
Liverpool , , United Kingdom
Liverpool , , United Kingdom
London , , United Kingdom
Manchester , , United Kingdom
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