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

Not Applicable

Completed

• Conditions: Syncope (unknown origin); Signs and Symptoms; Syncope and collapse

• Registration Number: ISRCTN00029383
• Lead Sponsor: Croix Rousse University Hospital (France)

Brief Summary

2012 results in https://pubmed.ncbi.nlm.nih.gov/22086879/ (added 29/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-12-31
• Study Start: 2010-07-23
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of syncope

Secondary Outcome Measures

Name	Time	Method
<br> 1. Duration of cardiac pause<br> 2. Reprogramming of pacemaker<br> 3. Recurrences after reprogramming<br>