Trial Outcomes & Findings for MODULA Modul 7 VRR (NCT NCT00180414)
NCT ID: NCT00180414
Last Updated: 2022-06-24
Results Overview
Comparison of the average percentage of biventricular pacing in subjects randomised to Ventricular Rate Regulation (VRR) = ON to subjects randomized to VRR = OFF
TERMINATED
NA
8 participants
6 month
2022-06-24
Participant Flow
Participant milestones
| Measure |
Ventricular Rate Regulation Feature ON
CRT devices with ventricular rate regulation \[VRR\] (CE labeled)
|
Ventricular Rate Regulation Feature OFF
CRT devices with ventricular rate regulation \[VRR\] (CE labeled)
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Ventricular Rate Regulation Feature ON
CRT devices with ventricular rate regulation \[VRR\] (CE labeled)
|
Ventricular Rate Regulation Feature OFF
CRT devices with ventricular rate regulation \[VRR\] (CE labeled)
|
|---|---|---|
|
Overall Study
Study cancellation due to lack of overall enrollments
|
4
|
4
|
Baseline Characteristics
MODULA Modul 7 VRR
Baseline characteristics by cohort
| Measure |
Ventricular Rate Regulation Feature ON
n=4 Participants
CRT devices with ventricular rate regulation \[VRR\] (CE labeled)
|
Ventricular Rate Regulation Feature OFF
n=4 Participants
CRT devices with ventricular rate regulation \[VRR\] (CE labeled)
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
72.3 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthPopulation: 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.
Comparison of the average percentage of biventricular pacing in subjects randomised to Ventricular Rate Regulation (VRR) = ON to subjects randomized to VRR = OFF
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 MonthPopulation: 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.
Correlation between VRR mode and the subjective quality of life (QOL) measured by a QOL questionnaire in both randomized groups
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Correlation between VRR mode and conducted atrial arrhythmias (if observed) in both randomized groups
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Correlation between VRR and physical ability in both randomized groups measured by a 6 minute walk test or an optional spiroergometry
Outcome measures
Outcome data not reported
Adverse Events
Ventricular Rate Regulation Feature ON
Ventricular Rate Regulation Feature OFF
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
- Publication restrictions are in place