Title of Trial
North American Vasovagal Pacemaker Study (VPS)

Initial Presentation
Connolly SJ, Sheldon R, Roberts R, et al. The North American vasovagal pacemaker study: A randomized trial of permanent cardiac pacing for the prevention of vasovagal syncope. J Am Coll Card 1999; 33: 16-20.

Date and Citation of Primary Publication(s) or References
Pending

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

Study Category
Pacing & Syncope

Patient Population
Inclusion Criteria
Six prior syncopal episodes and an estimated >50% rate of recurrence within one year. Positive tilt table test characterized by relative bradycardia (HR < 60 beats per minute without isoproterenol, < 70-80 bpm if isoproterenol was used).

Exclusion Criteria
Other probable causes for syncope (e.g. significant valvular, coronary and myocardial heart disease, etc.), a previously implanted pacemaker or major chronic noncardiovascular disease.

Study Design
Randomized controlled trial. Patients were randomized to pacemaker implantation or no pacemaker implantation.

Primary Endpoints
First recurrence of syncope

Secondary Endpoints
Syncope, injury

Baseline Characteristics
Patient number: 54 patients (study stopped prematurely due to an observed treatment effect)
Mean Age: 43 years
Gender: 74% female
Other characteristics: 55% had failed previous medical therapy.

Time to Follow-up
Mean follow-up 54 days in the no pacemaker group and 112 days in the pacemaker group.

Results
Seven adverse events were reported for the pacemaker group (one lead dislodgement, five patients with palpitations, and one patient with pacemaker activity at rest) and no adverse events were identified in the no-pacemaker group. As shown in the table, pacemaker therapy was associated with a significant reduction in syncope (hazard ratio: 0.85, 95% CI 0.60-0.95). No difference in measures of presyncope could be detected between the two groups. Baseline differences between the pacemaker and no-pacemaker group were evaluated post-hoc because of the small number of patients in the study. Patients in the no-pacemaker group had a trend toward more frequent syncopal episodes in the year prior to study entry (no-pacemaker group: median: 6, interquartile range: 3-40 vs. pacemaker group: median 3, interquartile range: 2-12) but no other significant baseline trends could be identified.

	No-pacemaker n = 27	Pacemaker n = 27	P
Recurrent syncope, n(%)	19 (70%)	6 (22%)	0.000022
Mean time from randomization to syncope (days)	54	112	Not stated
Syncope associated with bruises	4	0	Not stated
Presyncope, n (%)	20 (74%)	17 (63%)	0.56
Average rate of presyncope/ 100 days	10.0	4.5	0.21

Sponsor
Medtronic

Trial Status: Completed

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