An investigation into the performance of the pacing mode AA1R (R) with respect to the percentage ventricular pacing and the evolution of atrial fibrillation when compared to the mode DDD (R) in patients with Sick Sinus Syndrome (SAFE PACE)
| ISRCTN | ISRCTN22375710 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22375710 |
| Protocol serial number | N0143162643 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Hertfordshire Hospitals Research and Development Consortium (UK), NHS R&D Support Funding |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 28/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Jane Eldridge
Scientific
Scientific
Cardiac Catheter Lab
Hemel Hempstead General Hospital
Hillfield Road
Hemel Hempstead
HP2 4AD
United Kingdom
| Phone | +44 01442 287364 |
|---|---|
| jane.eldridge@whht.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Comparison of pacing modes AA1safe(R) R and DDD(R) in patients with Sick Sinus Syndrome. |
| Ethics approval(s) | Ethics approval was received from the local medical ethics committee before trial recruitment began. |
| Health condition(s) or problem(s) studied | Cardiovascular: Sick Sinus Syndrome |
| Intervention | Retrospective, randomised, longitudinal study of the percentage ventricular pacing and the evolution of atrial fibrillation when compared to the mode DDD (R) in patients with Sick Sinus Syndrome |
| Intervention type | Other |
| Primary outcome measure(s) |
Lower percentage of ventricular pacing and the amount of time spent in atrial fibrillation that occurs with each pacing mode |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | 100 patients with Sick Sinus Syndrome |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 15/04/2005 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cardiac Catheter Lab
Hemel Hempstead
HP2 4AD
United Kingdom
HP2 4AD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
