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| [ Print-friendly version ] |
| Comparative study of two types of pacing for the treatment of unexplained syncope (vasovagal syndrome) |
| ISRCTN | ISRCTN00029383 |
| ClinicalTrials.gov identifier | |
| Public title | Comparative study of two types of pacing for the treatment of unexplained syncope (vasovagal syndrome) |
| 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 |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis |
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. |
| Lay summary | |
| Ethics approval |
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 |
| Study design | Prospective multicentre comparative randomised single blind study with a direct individual benefit |
| Countries of recruitment | Belgium, France |
| Disease/condition/study domain | Syncope (unknown origin) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/07/2000 |
| Anticipated end date | 31/12/2005 |
| Status of trial | Completed |
| Patient information material | Can be found at https://www.healthstudies.umn.edu/trc/en/en_protocol-2002-02-21.pdf (see pg. 15-16) |
| Target number of participants | 200 patients (100 per group) |
| Interventions |
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. |
| Primary outcome measure(s) | Recurrence of syncope |
| Secondary outcome measure(s) |
1. Duration of cardiac pause
2. Reprogramming of pacemaker 3. Recurrences after reprogramming |
| Sources of funding | Medtronic, Inc. (USA) |
| Trial website | |
| Publications | |
| Contact name | Dr Daniel Flammang |
| Address |
Croix Rousse University Hospital
103 Grand Rue de la Croix Rousse |
| City/town | Lyon |
| Zip/Postcode | 69004 |
| Country | France |
| Tel | +33 (0)472 072865 |
| daniel.flammang@yahoo.fr | |
| Sponsor | Croix Rousse University Hospital (France) |
| Address |
Department of Cardiology
103 Grand Rue de la Croix Rousse |
| City/town | Lyon |
| Zip/Postcode | 69004 |
| Country | France |
| Tel | +33 (0)472 072865 |
| daniel.flammang@yahoo.fr | |
| Date applied | 15/04/2010 |
| Last edited | 23/07/2010 |
| Date ISRCTN assigned | 23/07/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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