Cardiac Autonomic Denervation for Cardio-inhibitory Syncope
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bradycardia; Syncope
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- recurrence of syncope
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Background: Autonomic system modification is an established therapeutic approach that has been increasingly used for the treatment of vagal-related symptomatic bradycardia, such as cardio-inhibitory vasovagal syncope1-12.
Although convincing results had been reported from small populations, a large randomized study providing robust evidence on the efficacy of this approach has not yet been performed.
Hypothesis: Cardiac autonomic system modification is effective for the treatment of vagal-related symptomatic bradycardia, and is associated better clinical results as compared to placebo.
Investigators
Mauricio Ibrahim Scanavacca
Director of arrhythmia and electrophysiology Unit
University of Sao Paulo General Hospital
Eligibility Criteria
Inclusion Criteria
- •Aged between 18 and 70 years old.
- •Cardio-inhibitory response (VASIS 2A or 2B) during tilt test, or after carotid sinus massage.
- •Patients with bradycardia mediated by vagal hypertonia documented on 24-hour Holter monitoring and a clear relationship with symptoms.
Exclusion Criteria
- •Ages under 18 and over 70
- •Presence of structural heart disease documented by echocardiography.
- •Hypothyroidism and hyperthyroidism, drug effects, obstructive sleep apnea and other causes of secondary bradycardia.
- •Anatomical disease of the conduction system.
Outcomes
Primary Outcomes
recurrence of syncope
Time Frame: 24 months
To compare the recurrence of syncope or pre-syncope and a negative tilt test with the different techniques of electrophysiological procedures currently used.
Secondary Outcomes
- electrocardiographic and electrophysiological parameters(24 months)