Trial Outcomes & Findings for Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT) (NCT NCT01475175)
NCT ID: NCT01475175
Last Updated: 2019-08-05
Results Overview
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.
TERMINATED
NA
12 participants
Test day visit (within 14 days of enrollment)
2019-08-05
Participant Flow
Twelve subjects were enrolled at six centers in Europe between November 2011 and March 2012.
Participant milestones
| Measure |
Adaptive CRT Pacing
Cardiac resynchronization therapy (CRT) with adaptive pacing.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)
Baseline characteristics by cohort
| Measure |
Adaptive CRT Pacing
n=12 Participants
Cardiac resynchronization therapy (CRT) with adaptive pacing.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 16.8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=93 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=93 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=93 Participants
|
|
Region of Enrollment
Norway
|
2 participants
n=93 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Test day visit (within 14 days of enrollment)Population: Echo SV data was complete for all 12 subjects.Two patients were programmed incorrectly during the study procedure.
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.
Outcome measures
| Measure |
Adaptive CRT Pacing
n=10 Participants
Cardiac resynchronization therapy (CRT) with adaptive pacing.
|
|---|---|
|
Stroke Volume at Rest
|
12.1 mL
Interval 8.4 to 22.2
|
PRIMARY outcome
Timeframe: Test day visit (within 14 days of enrollment)Population: Echo SV data was complete for all 12 subjects.
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.
Outcome measures
| Measure |
Adaptive CRT Pacing
n=12 Participants
Cardiac resynchronization therapy (CRT) with adaptive pacing.
|
|---|---|
|
Stroke Volume During Atrial Pacing.
|
9.4 mL
Interval 6.7 to 16.0
|
PRIMARY outcome
Timeframe: Test day visit (within 14 days of enrollment)Population: Echo SV data was complete for all 12 subjects.
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.
Outcome measures
| Measure |
Adaptive CRT Pacing
n=12 Participants
Cardiac resynchronization therapy (CRT) with adaptive pacing.
|
|---|---|
|
Stroke Volume During Sub-maximal Exercise.
|
11.3 mL
Interval 8.0 to 19.2
|
SECONDARY outcome
Timeframe: Test day visit (within 14 days of enrollment)Population: Data were not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Test day visit (within 14 days of enrollment)Population: Data were not collected
Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction at rest.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Test day visit (within 14 days of enrollment)Population: Data were not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Test day visit (within 14 days of enrollment)Population: Data were not collected.
Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction during sub-maximal exercise.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Test day visit (within 14 days of enrollment)Population: Data were not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time Frame: Test day visit (within 14 days of enrollment)Population: Data were not collected.
Electrical conduction will be evaluated during sub-maximal exercise by measuring the subject's intrinsic AV interval.
Outcome measures
Outcome data not reported
Adverse Events
Adaptive CRT Pacing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In most cases, contracts allow investigators to publish study results per the protocol and publication plan following Medtronic's review to determine whether confidential information (CI) is disclosed. Any such CI is deleted prior to publication/presentation. Medtronic may not censor/interfere with the publication except as described. Investigators may not publish any single-site publications until the main multi-site study publication has occurred.
- Publication restrictions are in place
Restriction type: OTHER