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Adaptive Cardiac Resynchronization Therapy Study (aCRT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Medtronic Cardiac Rhythm and Heart Failure.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier:
NCT00980057
First received: September 16, 2009
Last updated: September 5, 2012
Last verified: September 2012
  Purpose
The purpose of this study is to show that Adaptive CRT is at least as good at optimizing a patient's cardiac resynchronization therapy (CRT) as the current method of using an echocardiogram. Adaptive CRT (aCRT) is an implantable heart failure device feature that attempts to optimize CRT without echocardiographic testing.

Condition Intervention
Heart Failure Device: Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Other: Adaptive CRT (aCRT) Pacing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Adaptive Cardiac Resynchronization Therapy Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

Primary Outcome Measures:
  • Percentage of patients with improved heart failure outcomes Clinical Composite Score [ Time Frame: randomization to six month visit ]
  • Correlation between aortic velocity time integral (AoVTI) at Adaptive CRT and echo-optimized device settings (AoVTI is an echocardiographic representative of stroke volume and cardiac performance.) [ Time Frame: randomization visit and six month visit ]
  • Percentage of patients with a safety event (inappropriate AV or VV delay settings related to the aCRT feature) [ Time Frame: 6 months post randomization ]

Secondary Outcome Measures:
  • Right ventricular pacing percentage [ Time Frame: implant to six months post randomization ]
  • Change in left ventricular end systolic volume index (LVESVi) [ Time Frame: baseline to six month visit ]
  • Change in left ventricular ejection fraction (LVEF) [ Time Frame: baseline to six month visit ]
  • Change in New York Heart Association (NYHA) classification [ Time Frame: baseline to six month visit ]
  • Change in distance walked during the six minute hall walk [ Time Frame: baseline to six month visit ]
  • Change in quality of life measured by the Minnesota Living With Heart Failure Questionnaire (MLWHF) [ Time Frame: baseline to six month visit ]

Enrollment: 522
Study Start Date: November 2009
Estimated Study Completion Date: September 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adaptive CRT (aCRT) Pacing
Cardiac resynchronization therapy (CRT) with adaptive pacing
Device: Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)
Other Names:
  • Consulta® CRT-D
  • Maximo II® CRT-D
  • Concerto II® CRT-D
Other: Adaptive CRT (aCRT) Pacing
Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status
Other Name: AdaptivCRT
Active Comparator: Standard Biventricular Pacing
Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing)
Device: Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)
Other Names:
  • Consulta® CRT-D
  • Maximo II® CRT-D
  • Concerto II® CRT-D

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980057

  Show 106 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Study Chair: Adaptive CRT Trial Leader Medtronic