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Unable to reach sample size to satisfy the primary objective
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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.
Adaptive CRT is an implantable heart failure device feature that attempts to optimize CRT without echocardiographic testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT pacing at rest and during exercise | Experimental | Rest and sub-maximal exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT pacing at rest and during exercise | Device | CRT pacing with aCRT settings and BiV pacing with nominal programming at rest and during submaximal exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Test day visit (within 14 days of enrollment) |
| 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. | Test day visit (within 14 days of enrollment) |
| 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. | Test day visit (within 14 days of enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Test day visit (within 14 days of enrollment) |
| Cardiac Function With Nominal Settings at Rest. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AdOPT CRT/aCRT Study Team | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linz | Austria | |||||
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Twelve subjects were enrolled at six centers in Europe between November 2011 and March 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adaptive CRT Pacing | Cardiac resynchronization therapy (CRT) with adaptive pacing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adaptive CRT Pacing | Cardiac resynchronization therapy (CRT) with adaptive pacing. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Echo SV data was complete for all 12 subjects.Two patients were programmed incorrectly during the study procedure. | Posted | Mean | 95% Confidence Interval | mL | Test day visit (within 14 days of enrollment) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adaptive CRT Pacing | Cardiac resynchronization therapy (CRT) with adaptive pacing. |
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Planned interim evaluation of sample size calculation assumptions showed variability higher than assumed and planned sample size underpowered for assumed difference. Objectives were not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AdOpt CRT Clinical Research Specialist | Medtronic CRDM | 800-328-2518 | 62736 | medtronicCRMtrials@medtronic.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction at rest. |
| Test day visit (within 14 days of enrollment) |
| 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. | Test day visit (within 14 days of enrollment) |
| 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. | Test day visit (within 14 days of enrollment) |
| 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. | Test day visit (within 14 days of enrollment) |
| Electrical Conduction During Sub-maximal Exercise. | Electrical conduction will be evaluated during sub-maximal exercise by measuring the subject's intrinsic AV interval. | Time Frame: Test day visit (within 14 days of enrollment) |
| Genk |
| Belgium |
| Leuven | Belgium |
| Aarhus | Denmark |
| Lüdenscheid | Germany |
| Nijmegen | Netherlands |
| Oslo | Norway |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | 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. | Echo SV data was complete for all 12 subjects. | Posted | Mean | 95% Confidence Interval | mL | Test day visit (within 14 days of enrollment) |
|
|
|
| Primary | 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. | Echo SV data was complete for all 12 subjects. | Posted | Mean | 95% Confidence Interval | mL | Test day visit (within 14 days of enrollment) |
|
|
|
| Secondary | 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. | Data were not collected. | Posted | Test day visit (within 14 days of enrollment) |
|
|
| Secondary | 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. | Data were not collected | Posted | Test day visit (within 14 days of enrollment) |
|
|
| Secondary | 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. | Data were not collected. | Posted | Test day visit (within 14 days of enrollment) |
|
|
| Secondary | 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. | Data were not collected. | Posted | Test day visit (within 14 days of enrollment) |
|
|
| Secondary | 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. | Data were not collected. | Posted | Test day visit (within 14 days of enrollment) |
|
|
| Secondary | Electrical Conduction During Sub-maximal Exercise. | Electrical conduction will be evaluated during sub-maximal exercise by measuring the subject's intrinsic AV interval. | Data were not collected. | Posted | Time Frame: Test day visit (within 14 days of enrollment) |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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.