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North American Vasovagal Pacemaker Study: study design and organization
R S Sheldon1, M Gent, R S Roberts
1Cardiovascular Research Group, University of Calgary, Alberta, Canada.
Pacing and Clinical Electrophysiology : PACE
|March 1, 1997
Summary
This clinical trial investigates dual chamber pacing with rate drop sensing for frequent vasovagal syncope. The study aims to determine if this technology reduces syncope recurrence in affected patients.
Area of Science:
- Cardiology
- Neurology
- Clinical Trials
Background:
- Vasovagal syncope causes frequent syncopal spells, impacting quality of life.
- Tilt table testing is used to diagnose vasovagal syncope, often revealing relative bradycardia.
- Current therapies for frequent syncope may not be fully effective.
Purpose of the Study:
- To assess the efficacy of dual chamber pacing with rate drop sensing in reducing syncope recurrence.
- To evaluate the effectiveness of a specific pacemaker (Medtronic Thera DR) in managing vasovagal syncope.
- To determine if advanced pacing technology can improve outcomes for patients with recurrent syncope.
Main Methods:
- Multicenter randomized clinical trial design.
- Inclusion criteria: ≥6 syncopal spells and positive tilt table test with relative bradycardia.
- Randomization to dual chamber pacing with rate drop sensing versus usual therapy.
- Daily logging of syncopal spells and 2-monthly patient contact.
- Primary outcome: time to first syncope recurrence.
Main Results:
- Pilot study enrollment: 60 patients over 2 years.
- Main study goal: recruit 284 patients over 3 years.
- 47 patients enrolled to date since July 1995.
- Study powered to detect a 30% reduction in syncope risk.
Conclusions:
- Dual chamber pacing with rate drop sensing is being investigated as a novel treatment for vasovagal syncope.
- The study aims to provide evidence for the efficacy of this pacing strategy.
- Findings will inform clinical practice for managing patients with recurrent, unexplained syncope.