Comparative study of two types of pacing for the treatment of unexplained syncope (vasovagal syndrome)

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN00029383

Enrollment

200

Registered

2010-07-23

Start date

2000-07-01

Completion date

Unknown

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope (unknown origin) Signs and Symptoms Syncope and collapse

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. D

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Recurrence of syncope	—

Secondary

Measure	Time frame
1. Duration of cardiac pause 2. Reprogramming of pacemaker 3. Recurrences after reprogramming	—

Countries

Belgium, France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026