Actively Recruiting
Led by Institut d'Investigació Biomèdica de Bellvitge · Updated on 2024-01-25
90
Participants Needed
10
Research Sites
13 weeks
Total Duration
Reflex syncope, the most common type of fainting, can cause injuries and reduce quality of life. It results from an imbalance in the autonomic nervous system leading to low blood flow to the brain. Current non-drug and drug treatments often have limited success. This study aims to compare the effectiveness of cardioneuroablation (CNA), a newer catheter-based heart procedure, with permanent pacemaker therapy in reducing episodes of cardioinhibitory reflex syncope in patients over 40 years old. Participants will be randomly assigned to one of two groups: one receiving cardioneuroablation, which targets specific heart nerve clusters using radiofrequency energy to modulate autonomic function, and the other receiving a dual-chamber pacemaker programmed with specialized algorithms. The CNA procedure includes pre- and post-testing to confirm treatment effects, while the pacemaker group receives device implantation. Both groups will be followed for at least 12 months to assess treatment outcomes. Throughout the study, participants will undergo evaluations including heart rhythm monitoring during syncope episodes, tilt table and atropine tests to assess nerve function, and quality of life assessments. Researchers will track the number of syncope and presyncope events, long-term changes in heart nerve activity, complications, heart rhythm changes, and arrhythmia burden. Safety and effectiveness will be monitored over a year to guide optimal treatment choice for this condition.
CONDITIONS
Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure followed by immediate recovery
Participants receive either cardioneuroablation or permanent pacemaker therapy as treatment for cardioinhibitory reflex syncope.
1 procedure visit and several early post-procedure visits
Duration - 12 months
Participants are monitored for treatment effectiveness and complications, including evaluations at 1 and 12 months.
Visits at 1 month and 12 months post-treatment
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
R
Rodolfo San Antonio, MD, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
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
Jose Carlos M Pachon, Enrique Indalecio M Pachon, Maria Zelia Cunha Pachon...
https://pubmed.ncbi.nlm.nih.gov/21712276Tolga Aksu, Dhiraj Gupta, Andre D'Avila...
https://pubmed.ncbi.nlm.nih.gov/35362165Roman Piotrowski, Jakub Baran, Agnieszka Sikorska...
https://pubmed.ncbi.nlm.nih.gov/36114133