Comparing Cardioneuroablation and Permanent Pacemaker Therapy for Recurrent Cardioinhibitory Reflex Syncope in Adults Over 40

What this Trial Is About

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.

Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?