Back to results

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

Primary Purpose

Heart Failure

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

CRT pacing at rest and during exercise

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CRT pacing at rest and during exercise

Arm Description

Rest and sub-maximal exercise

Outcomes

Primary Outcome Measures

Stroke Volume at Rest

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.

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.

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

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.

Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction at rest.

Cardiac Function With aCRT Settings During Sub-maximal Exercise.

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.

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 at Rest.

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.

Electrical Conduction During Sub-maximal Exercise.

Electrical conduction will be evaluated during sub-maximal exercise by measuring the subject's intrinsic AV interval.

Full Information

NCT ID

NCT01475175

First Posted

November 16, 2011

Last Updated

June 19, 2019

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

1. Study Identification

Unique Protocol Identification Number

NCT01475175

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Terminated

Why Stopped

Unable to reach sample size to satisfy the primary objective

Study Start Date

November 2011 (Actual)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

5. 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CRT pacing at rest and during exercise

Arm Type

Experimental

Arm Description

Rest and sub-maximal exercise

Intervention Type

Device

Intervention Name(s)

CRT pacing at rest and during exercise

Intervention Description

CRT pacing with aCRT settings and BiV pacing with nominal programming at rest and during submaximal exercise

Primary Outcome Measure Information:

Title

Stroke Volume at Rest

Description

Time Frame

Test day visit (within 14 days of enrollment)

Title

Stroke Volume During Atrial Pacing.

Description

Time Frame

Test day visit (within 14 days of enrollment)

Title

Stroke Volume During Sub-maximal Exercise.

Description

Time Frame

Test day visit (within 14 days of enrollment)

Secondary Outcome Measure Information:

Title

Cardiac Function With aCRT Settings at Rest

Description

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.

Time Frame

Test day visit (within 14 days of enrollment)

Title

Cardiac Function With Nominal Settings at Rest.

Description

Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction at rest.

Time Frame

Test day visit (within 14 days of enrollment)

Title

Cardiac Function With aCRT Settings During Sub-maximal Exercise.

Description

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.

Time Frame

Test day visit (within 14 days of enrollment)

Title

Cardiac Function With Nominal Settings During Sub-maximal Exercise.

Description

Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction during sub-maximal exercise.

Time Frame

Test day visit (within 14 days of enrollment)

Title

Electrical Conduction at Rest.

Description

Time Frame

Test day visit (within 14 days of enrollment)

Title

Electrical Conduction During Sub-maximal Exercise.

Description

Electrical conduction will be evaluated during sub-maximal exercise by measuring the subject's intrinsic AV interval.

Time Frame

Time Frame: Test day visit (within 14 days of enrollment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AdOPT CRT/aCRT Study Team

Organizational Affiliation

Medtronic

Official's Role

Study Chair

Facility Information:

City

Linz

Country

Austria

City

Genk

Country

Belgium

City

Leuven

Country

Belgium

City

Arhus

Country

Denmark

City

Ludenscheid

Country

Germany

City

Nijmegen

Country

Netherlands

City

Oslo

Country

Norway

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs