Title of Trial
North American Vasovagal Pacemaker Study II (VPS II) (already in the section)

Date and citation of primary publication(s) or References
Connolly SJ, Sheldon R, Thorpe KE, et al. Pacemaker therapy for prevention of syncope in patients with recurrent severe vasovagal syncope: Second Vasovagal Pacemaker Study (VPS II): a randomized trial. JAMA 2003; 289: 2224-9

Purpose of the Trial
Evaluate the effects of pacing therapy in patients with severe vasovagal syncope.

Study Category
Syncope & Pacing

Patient Population
Inclusion Criteria
Patients > 19 years old with a typical history of vasovagal syncope with at least 6 episodes during their lifetime or at least 3 years in the prior 2 years. Positive tilt test with a heart rate blood pressure product of less than 6,000/min mmHg.

Exclusion Criteria
Any identifiable causes for syncope or important valvular, coronary, or myocardial disease.

Study Design
Randomized double blind trial. All patients had pacemakers implanted. After implantation the pacenmakers were randomized to the ODO pacing mode (sensing only) or the DDD pacing mode (sensing and pacing).

Primary Endpoint
Time to first recurrence of syncope

Baseline Characteristics
Patient number: 100 patients
Mean Age: 50 ± 18 years
Gender: 48% women in the ODO group and 73% women in the DDD group.
Other characteristics: 18% with severe bradycardia response (< 40 bpm)

Time to Follow-up
Six month follow-up.

Results
No differences in syncope recurrence were identified (ODO: 42% vs. DDD: 33%). Complications due to pacemaker implantation were observed in 10% of patients.

Sponsor: Medtronic

Trial Status: Completed