Actively Recruiting
Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?
Led by Institut d'Investigació Biomèdica de Bellvitge · Updated on 2024-01-25
90
Participants Needed
10
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Reflex syncope is the most common form of syncope. It can lead to injuries and affect quality of life. Nonpharmacological and medical therapies have limited effectiveness. In certain patients, cardiac pacing seem to be beneficial. More recently cardioneuroablation (CNA) has emerged as a novel therapy for reflex syncope. The investigators aim to determine whether CNA is more effective than cardiac pacing at reducing the rate of cardioinhibitory-type reflex syncope.
CONDITIONS
Official Title
Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged more than 40 years.
- At least two documented reflex syncope episodes in the past 12 months or one episode causing injury plus two presyncope events, unresponsive to standard treatments.
- Bradycardia-syncope link confirmed by ECG showing at least 3 seconds of asystole during spontaneous syncope.
- If ECG evidence is lacking, a positive cardioinhibitory response on tilt test (VASIS type 2A or 2B).
- Indicators for pacing according to ESC guidelines for reflex syncope.
- Significantly reduced quality of life due to syncope.
- Sinus rhythm confirmed on ECG.
- Provided written informed consent.
You will not qualify if you...
- Intrinsic sinus or atrioventricular node disease requiring permanent pacemaker implantation.
- Structural heart disease present.
- Contraindications to ablation in the right or left atrium.
- Life expectancy less than 12 months.
- Unwillingness to comply with randomization.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Hospital Universitario San Juan de Alicante
Sant Joan d'Alacant, Alicante, Spain, 03550
Not Yet Recruiting
2
Hospital Universitari General de Castellón
Castellon, Castellón, Spain, 12004
Not Yet Recruiting
3
Hospital Universitario Álvaro Cunqueiro de Vigo
Vigo, Pontevedra, Spain, 36312
Not Yet Recruiting
4
Hospital del Mar
Barcelona, Spain, 08003
Not Yet Recruiting
5
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Not Yet Recruiting
6
Hospital Universitario de Bellvitge
Barcelona, Spain, 08907
Actively Recruiting
7
Hospital Universitari Dr. Josep Trueta
Girona, Spain, 17007
Not Yet Recruiting
8
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain, 38010
Not Yet Recruiting
9
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Not Yet Recruiting
10
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Not Yet Recruiting
Research Team
R
Rodolfo San Antonio, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here