Comparative study of two types of pacing for the treatment of unexplained syncope (vasovagal syndrome)
| ISRCTN | ISRCTN00029383 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00029383 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/04/2010
- Registration date
- 23/07/2010
- Last edited
- 29/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Daniel Flammang
Scientific
Scientific
Croix Rousse University Hospital
103 Grand Rue de la Croix Rousse
Lyon
69004
France
| Phone | +33 (0)472 072865 |
|---|---|
| daniel.flammang@yahoo.fr |
Study information
| Study design | Prospective multicentre comparative randomised single blind study with a direct individual benefit |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at https://www.healthstudies.umn.edu/trc/en/en_protocol-2002-02-21.pdf (see pg. 15-16) |
| Scientific title | Comparative study of two types of pacing for the treatment of unexplained syncope (vasovagal syndrome): a multicentre, single-blinded, randomised controlled trial with a direct individual benefit |
| Study objectives | To compare the effectiveness of a dual chamber pacing (DDD) at 70 beats per minute (bpm) and a single chamber atrial pacing (AAI) at 30 bpm in patients suffering from vasovagal syndrome related to a predominant cardio-inhibitory reflex determined by adenosine-5'-triphosphate (ATP) test. Null hypothesis: The cumulative percentage syncope recurrence in the 30 bpm AAI-mode stimulated group, rp, equals that in the 70 bpm DDD-mode group, rw. Thus, rp=rw=r0. Alternative hypothesis: rp=arw, where a =/= 1. |
| Ethics approval(s) | 1. The Ethics Committee of Poitiers University approved on the 1st of September 1999 (ref: 99.07.22) 2. Individual ethics committees of each clinical centre |
| Health condition(s) or problem(s) studied | Syncope (unknown origin) |
| Intervention | ATP testing was carried out prior to randomisation. Only patients with block at least 10 seconds in duration were randomised to pacemaker implantation and programming with either: 1. Dual chamber pacing (DDD) at 70 bpm 2. Single chamber atrial pacing (AAI) at 30 bpm An injection of adenosine triphosphate will be used to screen for cardiac pause. The implantation is permanent, but the programming was set for the duration of the study to the random assignment. At the end of the study the recommended programming was to the more successful settings in the study, DDD @ 70bpm. The total follow-up was from January 2000 until May 2005. |
| Intervention type | Other |
| Primary outcome measure | Recurrence of syncope |
| Secondary outcome measures | 1. Duration of cardiac pause 2. Reprogramming of pacemaker 3. Recurrences after reprogramming |
| Overall study start date | 01/07/2000 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 patients (100 per group) |
| Total final enrolment | 80 |
| Key inclusion criteria | 1. Adult patients (greater than or equal to 18 years), agreeing to take part in the study and having signed the informed consent form 2. Patients having presented one or more episodes of syncope or pre-syncope unexplained by the usual screening tests: questionnaire, clinical examination, orthostatic hypotension investigation, biological tests, electrophysiological study (if necessary), echocardiogram (ECG), Holter, exercise test (optional), electroencephalogram (EEG) (optional), and brain scan (optional) 3. Negative sino-carotid massage (SCM) 4. Head-up tilt test conducted according to Appendix B protocol, whatever the result 5. Positive adenosine-5'-triphospate (ATP) test, confirmed by double reading by principal investigator |
| Key exclusion criteria | 1. Syncope etiology revealed by usual screening testings 2. Positive SCM 3. Atrial or ventricular tachyarrhythmia 4. Defibrillator implanted (DAI) 5. Pacemaker previously implanted 6. Patient on waiting list for or having had heart transplantation 7. Sick sinus syndrome, brady-tachy syndrome 8. Atrial fibrillation, paroxysmal or permanent first and second-degree atrio-ventricular block, trifascicular block 9. Ongoing pregnancy. Women of childbearing age should be using reliable contraception. 10. Acute systemic infection or other surgical contra-indication for pacemaker implantation 11. Chronic obstructive bronchopneumopathy 12. Asthma 13. Diabetes |
| Date of first enrolment | 01/07/2000 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Belgium
- France
Study participating centre
Croix Rousse University Hospital
Lyon
69004
France
69004
France
Sponsor information
Croix Rousse University Hospital (France)
Hospital/treatment centre
Hospital/treatment centre
Department of Cardiology
103 Grand Rue de la Croix Rousse
Lyon
69004
France
| Phone | +33 (0)472 072865 |
|---|---|
| daniel.flammang@yahoo.fr | |
"ROR" |
https://ror.org/006evg656 |
Funders
Funder type
Industry
Medtronic, Inc. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/01/2012 | 29/12/2020 | Yes | No |
Editorial Notes
29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
