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

• ClinicalTrials.gov Identifier: NCT01475175
• Recruitment Status: Terminated
• First Posted: November 21, 2011
• Results First Posted: October 12, 2012
• Last Update Posted: August 5, 2019
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Information provided by (Responsible Party): Medtronic Cardiac Rhythm and Heart Failure

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Heart Failure	Device: CRT pacing at rest and during exercise	Not Applicable

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)
• Actual Study Start Date: November 2011
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: CRT pacing at rest and during exercise; Rest and sub-maximal exercise	Device: CRT pacing at rest and during exercise; CRT pacing with aCRT settings and BiV pacing with nominal programming at rest and during submaximal exercise

Outcome Measures

Primary Outcome Measures :

1. Stroke Volume at Rest [ Time Frame: Test day visit (within 14 days of enrollment) ]
   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.
2. Stroke Volume During Atrial Pacing. [ Time Frame: Test day visit (within 14 days of enrollment) ]
   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.
3. Stroke Volume During Sub-maximal Exercise. [ Time Frame: Test day visit (within 14 days of enrollment) ]
   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 :

1. Cardiac Function With aCRT Settings at Rest [ Time Frame: Test day visit (within 14 days of enrollment) ]
   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.
2. Cardiac Function With Nominal Settings at Rest. [ Time Frame: Test day visit (within 14 days of enrollment) ]
   Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction at rest.
3. Cardiac Function With aCRT Settings During Sub-maximal Exercise. [ Time Frame: Test day visit (within 14 days of enrollment) ]
   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.
4. Cardiac Function With Nominal Settings During Sub-maximal Exercise. [ Time Frame: Test day visit (within 14 days of enrollment) ]
   Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction during sub-maximal exercise.
5. Electrical Conduction at Rest. [ Time Frame: Test day visit (within 14 days of enrollment) ]
   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.
6. Electrical Conduction During Sub-maximal Exercise. [ Time Frame: Time Frame: Test day visit (within 14 days of enrollment) ]
   Electrical conduction will be evaluated during sub-maximal exercise by measuring the subject's intrinsic AV interval.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Austria

Linz, Austria

Belgium

Genk, Belgium

Leuven, Belgium

Denmark

Arhus, Denmark

Germany

Ludenscheid, Germany

Netherlands

Nijmegen, Netherlands

Norway

Oslo, Norway

Sponsors and Collaborators

Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Study Chair: AdOPT CRT/aCRT Study Team; Medtronic

More Information

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT01475175
• Other Study ID Numbers: AdOPT CRT Sub Study
• First Posted: November 21, 2011
• Results First Posted: October 12, 2012
• Last Update Posted: August 5, 2019
• Last Verified: June 2019

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases