Atrial Fibrillation
Conditions
Keywords
heart failure
Brief summary
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.
Detailed description
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.
Interventions
DEVICECRT devices with ventricular rate regulation [VRR] (CE labeled)
Sponsors
Guidant Corporation
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with CRT system with the VRR algorithm * Patients with permanent atrial fibrillation * Occasional conducted atrial fibrillation resulting in ventricular rates \> 70 beats per minute (bpm) * QRS complex \> 120 ms
Exclusion criteria
* Patients with third degree atrioventricular (AV) block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Biventricular Pacing | 6 month | Comparison of the average percentage of biventricular pacing in subjects randomised to Ventricular Rate Regulation (VRR) = ON to subjects randomized to VRR = OFF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between VRR and the Subjective Quality of Life | 6 Month | Correlation between VRR mode and the subjective quality of life (QOL) measured by a QOL questionnaire in both randomized groups |
| Correlation Between VRR and the Symptoms Caused by Conducted Atrial Arrhythmias | 6 months | Correlation between VRR mode and conducted atrial arrhythmias (if observed) in both randomized groups |
| Correlation Between VRR and Physical Ability (6 Minute Walk Test, Optional Spiroergometry) | 6 months | Correlation between VRR and physical ability in both randomized groups measured by a 6 minute walk test or an optional spiroergometry |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ventricular Rate Regulation Feature ON CRT devices with ventricular rate regulation \[VRR\] (CE labeled) | 4 |
| Ventricular Rate Regulation Feature OFF CRT devices with ventricular rate regulation \[VRR\] (CE labeled) | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study cancellation due to lack of overall enrollments | 4 | 4 |
Baseline characteristics
| Characteristic | Ventricular Rate Regulation Feature ON | Ventricular Rate Regulation Feature OFF | Total |
|---|---|---|---|
| Age, Continuous | NA years | NA years | 72.3 years STANDARD_DEVIATION 6.5 |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
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
Time frame: 6 month
Population: 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.
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
Time frame: 6 months
Population: 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.
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
Time frame: 6 Month
Population: 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.
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
Time frame: 6 months
Population: 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.