Adaptive Cardiac Resynchronization Therapy Study - Full Text View

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:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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

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

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):

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.

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 May 23, 2013

Adaptive Cardiac Resynchronization Therapy Study (aCRT)