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low enrolment rate
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| Name | Class |
|---|---|
| Guidant Corporation | INDUSTRY |
This study will look at the correlation between ventricular rate regulation (VRR) and the percentage of biventricular pacing as well as subjective quality of life and level of physical ability in CRT patients with atrial fibrillation.
To investigate whether VRR can increase the amount of biventricular pacing in CRT patients with conducted atrial arrhythmias. Secondarily, an investigation will be carried out to determine whether this increase in biventricular pacing results in an improvement in quality of life, as well as an improvement in the symptoms caused by the atrial arrhythmia and an improvement in the level of physical ability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventricular Rate Regulation feature ON | Experimental |
| |
| Ventricular Rate Regulation feature OFF | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT devices with ventricular rate regulation [VRR] (CE labeled) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Biventricular Pacing | Comparison of the average percentage of biventricular pacing in subjects randomised to Ventricular Rate Regulation (VRR) = ON to subjects randomized to VRR = OFF | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between VRR and the Subjective Quality of Life | Correlation between VRR mode and the subjective quality of life (QOL) measured by a QOL questionnaire in both randomized groups | 6 Month |
| Correlation Between VRR and the Symptoms Caused by Conducted Atrial Arrhythmias |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernd Lemke, MD | Klinikum Lüdenscheid / Kardiologie / Paulmannshöher Straße 14 / 58515 Lüdenscheid / Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Lüdenscheid / Kardiologie | Lüdenscheid | 58515 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ventricular Rate Regulation Feature ON | CRT devices with ventricular rate regulation [VRR] (CE labeled) |
| FG001 | Ventricular Rate Regulation Feature OFF | CRT devices with ventricular rate regulation [VRR] (CE labeled) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ventricular Rate Regulation Feature ON | CRT devices with ventricular rate regulation [VRR] (CE labeled) |
| BG001 | Ventricular Rate Regulation Feature OFF | CRT devices with ventricular rate regulation [VRR] (CE labeled) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Biventricular Pacing | Comparison of the average percentage of biventricular pacing in subjects randomised to Ventricular Rate Regulation (VRR) = ON to subjects randomized to VRR = OFF | An insufficient number of subjects was enrolled as well as the overall data quality of this investigation did not allow for any conclusions regarding the endpoint. Endpoints were not analyzed, final report does not contain information about analysis. Individual data deleted meanwhile per applicable data storage regulations and unavailable for further analysis, hence detailed results are impossible to be provided. | Posted | 6 month |
|
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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 | Ventricular Rate Regulation Feature ON | CRT devices with ventricular rate regulation [VRR] (CE labeled) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jens Goetzke | Boston Scientific | +32 2 41 | 67011 | jens.goetzke@bsci.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Correlation between VRR mode and conducted atrial arrhythmias (if observed) in both randomized groups |
| 6 months |
| Correlation Between VRR and Physical Ability (6 Minute Walk Test, Optional Spiroergometry) | Correlation between VRR and physical ability in both randomized groups measured by a 6 minute walk test or an optional spiroergometry | 6 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ventricular Rate Regulation Feature OFF |
CRT devices with ventricular rate regulation [VRR] (CE labeled) |
|
| Secondary | Correlation Between VRR and the Subjective Quality of Life | Correlation between VRR mode and the subjective quality of life (QOL) measured by a QOL questionnaire in both randomized groups | An insufficient number of subjects was enrolled as well as the overall data quality of this investigation did not allow for any conclusions regarding the endpoint. Endpoints were not analyzed, final report does not contain information about analysis. Individual data deleted meanwhile per applicable data storage regulations and unavailable for further analysis, hence detailed results are impossible to be provided. | Posted | 6 Month |
|
|
| Secondary | Correlation Between VRR and the Symptoms Caused by Conducted Atrial Arrhythmias | Correlation between VRR mode and conducted atrial arrhythmias (if observed) in both randomized groups | An insufficient number of subjects was enrolled as well as the overall data quality of this investigation did not allow for any conclusions regarding the endpoint. Endpoints were not analyzed, final report does not contain information about analysis. Individual data deleted meanwhile per applicable data storage regulations and unavailable for further analysis, hence detailed results are impossible to be provided. | Posted | 6 months |
|
|
| Secondary | Correlation Between VRR and Physical Ability (6 Minute Walk Test, Optional Spiroergometry) | Correlation between VRR and physical ability in both randomized groups measured by a 6 minute walk test or an optional spiroergometry | An insufficient number of subjects was enrolled as well as the overall data quality of this investigation did not allow for any conclusions regarding the endpoint. Endpoints were not analyzed, final report does not contain information about analysis. Individual data deleted meanwhile per applicable data storage regulations and unavailable for further analysis, hence detailed results are impossible to be provided. | Posted | 6 months |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Ventricular Rate Regulation Feature OFF | CRT devices with ventricular rate regulation [VRR] (CE labeled) | 0 | 4 | 0 | 4 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |