Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
522 participants
INTERVENTIONAL
2009-10-01
2012-03-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)
NCT01475175
AdaptResponse Clinical Trial
NCT02205359
Resynchronization/Defibrillation for Ambulatory Heart Failure Trial
NCT00251251
Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
NCT00683696
Cardiac Resynchronization Therapy (CRT)-Narrow-dp/Dt-Study
NCT00821938
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* to demonstrate that over 6-month follow-up, the proportion of the patients improved in the aCRT arm is at least as high as in the Echo arm
* to demonstrate that cardiac function is similar when using aCRT versus echo-optimized settings
* to demonstrate that aCRT does not result in inappropriate AV or VV delay settings
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adaptive CRT (aCRT) arm
Intervention: Cardiac resynchronization therapy (CRT-D) with Adaptive CRT algorithm ON
Adaptive CRT (aCRT)
Adaptive CRT (aCRT) is an algorithm, which provides ambulatory adjustment of pacing configuration (LV-only or BiV) and AV and VV delays based on periodic automatic evaluation of electrical conduction to optimize cardiac function
Echo-optimized arm
Intervention: Cardiac resynchronization therapy (CRT-D) with standard biventricular pacing (Adaptive CRT algorithm OFF)
Echo
Standard BiV pacing with settings optimized using a standardized echocardiographic protocol
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Adaptive CRT (aCRT)
Adaptive CRT (aCRT) is an algorithm, which provides ambulatory adjustment of pacing configuration (LV-only or BiV) and AV and VV delays based on periodic automatic evaluation of electrical conduction to optimize cardiac function
Echo
Standard BiV pacing with settings optimized using a standardized echocardiographic protocol
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject is at least 18 years of age (or older, if required by local law)
* Subject is expected to remain available for at least six months of follow-up visits
* Subject is indicated for a study device that will be implanted within 30 days after signing the Informed Consent form
* Subject has an intrinsic QRS duration greater than or equal to 120 milliseconds (documented within 30 days prior to enrollment)
* Subject has a left ventricular ejection fraction less than or equal to 35 percent (method per physician discretion) (documented within 180 days prior to enrollment)
* Subject is diagnosed with New York Heart Association (NYHA) class III or IV (within 30 days prior to enrollment) despite optimal medical therapy which is defined as: ACE-inhibitor (Angiotensin-Converting Enzyme) or Angiotensin II Receptor Blocker (ARB), if tolerated, for at least one month prior to implant, AND beta-blocker for at least three months preceding implant, if tolerated, and stable for one month, OR subject has an urgent medical need for an implantable cardioverter defibrillator (ICD) that precludes waiting the one or three months for the medication requirements for ACE inhibitor, ARB or beta-blocker
Exclusion Criteria
* Subject has existing CRT system
* Subject has non-intact or unstable leads
* Subject has medical conditions that would limit study participation (per physician discretion)
* Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by Medtronic
* Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) (documented within 30 days prior to enrollment)
* Subject has a mechanical right 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 that would not allow completion of the 6 month visit
* Subject is pregnant (In the United States, all women of child-bearing potential must undergo a pregnancy test within seven days prior to aCRT download into device)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adaptive CRT Trial Leader
Role: STUDY_CHAIR
Medtronic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Huntsville, Alabama, United States
Anchorage, Alaska, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Glendale, California, United States
San Bernardino, California, United States
San Diego, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Augusta, Georgia, United States
Barrington, Illinois, United States
Fort Wayne, Indiana, United States
Davenport, Iowa, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Takoma Park, Maryland, United States
Burlington, Massachusetts, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Saginaw, Michigan, United States
Saint Cloud, Minnesota, United States
Saint Louis Park, Minnesota, United States
Saint Paul, Minnesota, United States
Tupelo, Mississippi, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Morristown, New Jersey, United States
Brooklyn, New York, United States
Buffalo, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Charleston, South Carolina, United States
Spartanburg, South Carolina, United States
Chattanooga, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Tyler, Texas, United States
Burlington, Vermont, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Bellingham, Washington, United States
Spokane, Washington, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
Adelaide, , Australia
Camperdown, , Australia
Chermside, , Australia
Darlinghurst, , Australia
Perth, , Australia
Spring Hill, , Australia
Linz, , Austria
Genk, , Belgium
Leuven, , Belgium
Yvoir, , Belgium
Calgary, , Canada
London, , Canada
Montreal, , Canada
Newmarket, , Canada
Ottawa, , Canada
Victoria, , Canada
Aalborg, , Denmark
Aarhus, , Denmark
Copenhagen, , Denmark
Odense, , Denmark
Bochum, , Germany
Hamburg, , Germany
Lüdenscheid, , Germany
Reinbek, , Germany
Trier, , Germany
Athens, , Greece
Hong Kong, , Hong Kong
Budapest, , Hungary
Milan, , Italy
Pavia, , Italy
Pedara, , Italy
Rozzano, , Italy
Osaka, , Japan
Tokyo, , Japan
Tsukuba, , Japan
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Bergen, , Norway
Oslo, , Norway
Tyumen, , Russia
Riyadh, , Saudi Arabia
Belgrade, , Serbia
Kamenitz, , Serbia
Niš, , Serbia
Albacete, , Spain
Madrid, , Spain
Majadahonda, , Spain
Vitoria-Gasteiz, , Spain
Lund, , Sweden
Stockholm, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gasparini M, Birnie D, Lemke B, Aonuma K, Lee KL, Gorcsan J 3rd, Landolina M, Klepfer R, Meloni S, Cicconelli M, Grammatico A, Martin DO. Adaptive Cardiac Resynchronization Therapy Reduces Atrial Fibrillation Incidence in Heart Failure Patients With Prolonged AV Conduction: The Adaptive CRT Randomized Trial. Circ Arrhythm Electrophysiol. 2019 May;12(5):e007260. doi: 10.1161/CIRCEP.119.007260. No abstract available.
Birnie D, Hudnall H, Lemke B, Aonuma K, Lee KL, Gasparini M, Gorcsan J 3rd, Cerkvenik J, Martin DO. Continuous optimization of cardiac resynchronization therapy reduces atrial fibrillation in heart failure patients: Results of the Adaptive Cardiac Resynchronization Therapy Trial. Heart Rhythm. 2017 Dec;14(12):1820-1825. doi: 10.1016/j.hrthm.2017.08.017. Epub 2017 Sep 9.
Yamasaki H, Lustgarten D, Cerkvenik J, Birnie D, Gasparini M, Lee KL, Sekiguchi Y, Varma N, Lemke B, Starling RC, Aonuma K. Adaptive CRT in patients with normal AV conduction and left bundle branch block: Does QRS duration matter? Int J Cardiol. 2017 Aug 1;240:297-301. doi: 10.1016/j.ijcard.2017.04.036. Epub 2017 Apr 12.
Starling RC, Krum H, Bril S, Tsintzos SI, Rogers T, Hudnall JH, Martin DO. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. 2015 Jul;3(7):565-572. doi: 10.1016/j.jchf.2015.03.001. Epub 2015 Jun 10.
Birnie D, Lemke B, Aonuma K, Krum H, Lee KL, Gasparini M, Starling RC, Milasinovic G, Gorcsan J 3rd, Houmsse M, Abeyratne A, Sambelashvili A, Martin DO. Clinical outcomes with synchronized left ventricular pacing: analysis of the adaptive CRT trial. Heart Rhythm. 2013 Sep;10(9):1368-74. doi: 10.1016/j.hrthm.2013.07.007. Epub 2013 Jul 11.
Krum H, Lemke B, Birnie D, Lee KL, Aonuma K, Starling RC, Gasparini M, Gorcsan J, Rogers T, Sambelashvili A, Kalmes A, Martin D. A novel algorithm for individualized cardiac resynchronization therapy: rationale and design of the adaptive cardiac resynchronization therapy trial. Am Heart J. 2012 May;163(5):747-752.e1. doi: 10.1016/j.ahj.2012.02.007.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Adaptive CRT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.