Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)

This study has been terminated.
(Decision was made to stop the study based on a pre-planned interim analysis that the sample size would unlikely be sufficient to satisfy the primary objective.)
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01475175
First received: November 16, 2011
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

The AdOPT Cardiac Resynchronization Therapy (CRT) study is an acute, prospective, multi-center, non-randomized investigational study designed to compare indices of cardiac function at device settings optimized using the investigational Adaptive CRT (aCRT) algorithm versus nominal programming. The comparison will be performed during rest, atrial pacing and sub-maximal exercise. AdOPT CRT is a sub study of the Adaptive CRT Study (NTC00980057) being conducted in Europe.


Condition Intervention
Heart Failure
Device: Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Medtronic Vision 3D™
Other: Adaptive CRT (aCRT) Pacing

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Stroke Volume at Rest [ Time Frame: Test day visit (within 14 days of enrollment) ] [ Designated as safety issue: No ]
    Difference in stroke volume (SV) between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest. Biventricular pacing is a type of pacing that paces both the right and left ventricles of the heart. Stroke volume is the volume of blood pumped from a ventricle in one heart beat.

  • Stroke Volume During Atrial Pacing. [ Time Frame: Test day visit (within 14 days of enrollment) ] [ Designated as safety issue: No ]
    Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during atrial pacing. Atrial pacing occurs at 20 beats-per-minute (bpm) above the subject's resting heart rate.

  • Stroke Volume During Sub-maximal Exercise. [ Time Frame: Test day visit (within 14 days of enrollment) ] [ Designated as safety issue: No ]
    Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise. Sub-maximal exercise is exercise performed at a level below maximum effort. The subject will perform sub-maximal exercise to achieve target heart rate close to 75% of the age-predicted maximal heart rate.


Secondary Outcome Measures:
  • Cardiac Function With aCRT Settings at Rest [ Time Frame: Test day visit (within 14 days of enrollment) ] [ Designated as safety issue: No ]
    Difference in blood pressure (BP)-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest.

  • Cardiac Function With Nominal Settings at Rest. [ Time Frame: Test day visit (within 14 days of enrollment) ] [ Designated as safety issue: No ]
    Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction at rest.

  • Electrical Conduction at Rest. [ Time Frame: Test day visit (within 14 days of enrollment) ] [ Designated as safety issue: No ]
    Electrical conduction will be evaluated at rest by measuring the subject's intrinsic atrio-ventricular (AV) interval. The AV interval is the amount time between the start of atrial contraction and the start of ventricular contraction.

  • Cardiac Function With aCRT Settings During Sub-maximal Exercise. [ Time Frame: Test day visit (within 14 days of enrollment) ] [ Designated as safety issue: No ]
    Difference in BP-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise.

  • Cardiac Function With Nominal Settings During Sub-maximal Exercise. [ Time Frame: Test day visit (within 14 days of enrollment) ] [ Designated as safety issue: No ]
    Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction during sub-maximal exercise.

  • Electrical Conduction During Sub-maximal Exercise. [ Time Frame: Time Frame: Test day visit (within 14 days of enrollment) ] [ Designated as safety issue: No ]
    Electrical conduction will be evaluated during sub-maximal exercise by measuring the subject's intrinsic AV interval.


Enrollment: 12
Study Start Date: November 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adaptive CRT Pacing
Cardiac resynchronization therapy (CRT) with adaptive pacing.
Device: Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Medtronic Vision 3D™
Market approved Medtronic Vision 3D™ CRT-D implantable device.
Other: Adaptive CRT (aCRT) Pacing
Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status.

Detailed Description:

Adaptive CRT is an implantable heart failure device feature that attempts to optimize CRT without echocardiographic testing.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is age 18 or greater
  • Subject is willing to sign and date the study Informed Consent form
  • Subject has been implanted with a clinically indicated CRT-D device (Medtronic Vision 3D or Protecta models) for at least 1 month but less than 7 months from the date of study enrollment

Exclusion Criteria:

  • Subject has a history of persistent or permanent AF for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted.
  • Subject has atrial or ventricular tachyarrhythmias or frequent atrial or ventricular ectopy at the time of enrollment.
  • Subject's resting heart rate at the time of enrollment exceeds 90 bpm.
  • Subject had CRT system implanted for more than 7 months from the date of the study enrollment
  • Subject has complete AV block.
  • Subject had previous mechanical valve surgeries.
  • Subject has congenital heart disease.
  • Subject has contraindication for an exercise test.
  • Subject is unable to perform a sub-maximal exercise test.
  • It is not possible to acquire technically acceptable echocardiographic images.
  • Subject has medical conditions that would limit study participation.
  • Subject is pregnant (all women of child-bearing potential must undergo a pregnancy test within seven days prior to the study visit).
  • Subject is enrolled in the Adaptive CRT study
  • Subject is enrolled in concurrent studies which could confound the results of this study.
  • Subject meets 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: NCT01475175

Locations
Austria
Linz, Austria
Belgium
Genk, Belgium
Leuven, Belgium
Denmark
Arhus, Denmark
Germany
Ludenscheid, Germany
Netherlands
Nijmegen, Netherlands
Norway
Oslo, Norway
Serbia
Belgrade, Serbia
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: AdOPT CRT/aCRT Study Team Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01475175     History of Changes
Other Study ID Numbers: AdOPT CRT Sub Study
Study First Received: November 16, 2011
Results First Received: September 12, 2012
Last Updated: September 12, 2012
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Ministry of Social Affairs, Public Health and the Environment
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
Germany: German Institute of Medical Documentation and Information
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Ministry of Health, Welfare and Sport
Norway: Directorate of Health

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014