Adaptive Cardiac Resynchronization Therapy Study

Completed · Not applicable

Conditions studied: Heart Failure

In brief

The purpose of this study is to demonstrate the AdaptivCRT algorithm is at least as good as manual echo based optimization in regard to patient outcomes and cardiac performance

Key facts

Study ID

NCT00980057

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

522

Starts

2009-10-01

Expected to finish

2012-03-08

Last updated by the study team

2018-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is willing to sign and date the study Informed Consent form
• 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

You may not qualify if…

• Subject has chronic (permanent) atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
• 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)
• Subject meets the exclusion criteria required by local law

Where it is running

• Study site — Anchorage, Alaska, United States
• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Glendale, California, United States
• Study site — San Bernardino, California, United States
• Study site — San Diego, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Clearwater, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Barrington, Illinois, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Davenport, Iowa, United States
• Study site — Des Moines, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Takoma Park, Maryland, United States
• Study site — Burlington, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Saginaw, Michigan, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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