Adaptive Cardiac Resynchronization Therapy Study (aCRT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Disease Management:

Primary Outcome Measures:
  • Percentage of patients with improved heart failure outcomes Clinical Composite Score [ Time Frame: randomization to six month visit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of patients with a safety event (inappropriate AV or VV delay settings related to the aCRT feature) [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Right ventricular pacing percentage [ Time Frame: implant to six months post randomization ] [ Designated as safety issue: No ]
  • Change in left ventricular end systolic volume index (LVESVi) [ Time Frame: baseline to six month visit ] [ Designated as safety issue: No ]
  • Change in left ventricular ejection fraction (LVEF) [ Time Frame: baseline to six month visit ] [ Designated as safety issue: No ]
  • Change in New York Heart Association (NYHA) classification [ Time Frame: baseline to six month visit ] [ Designated as safety issue: No ]
  • Change in distance walked during the six minute hall walk [ Time Frame: baseline to six month visit ] [ Designated as safety issue: No ]
  • Change in quality of life measured by the Minnesota Living With Heart Failure Questionnaire (MLWHF) [ Time Frame: baseline to six month visit ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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 Disease Management
Investigators
Study Chair: Adaptive CRT Trial Leader Medtronic
  More Information

No publications provided by Medtronic Cardiac Rhythm Disease Management

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00980057     History of Changes
Other Study ID Numbers: Adaptive CRT
Study First Received: September 16, 2009
Last Updated: September 5, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Austria: Federal Office for Safety in Health Care
Belgium: Ministry of Social Affairs, Public Health and the Environment
Canada: Ethics Review Committee
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Denmark: Danish Data Protection Agency
Germany: German Institute of Medical Documentation and Information
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health and Welfare
Greece: National Organization of Medicines
Hong Kong: Ethics Committee
Hungary: Office of Health Authorization and Administrative Procedures Department of Medical Devices
Italy: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Japan: Institutional Review Board
Japan: Pharmaceuticals and Medical Devices Agency
Netherlands: Ministry of Health, Welfare and Sport
Norway: Directorate of Health
Russia: Ministry of Health of the Russian Federation
Saudi Arabia: Ministry of Health
Serbia: Medicines and Medical Devices Agency of Serbia
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014