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Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?

RecruitingNAAges 40 Years - anyAllInstitut d'Investigació Biomèdica de Bellvitge
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Aged more than 40 years. * Having a 12-month history that includes at least two documented episodes of spontaneous reflex syncope or one episode that led to injury in addition to at least two presyncopal events, refractory to all recommended types of standard treatment. * Bradycardia-syncope correlation (at least 3 seconds of asystole due to sinus arrest or atrio-ventricular block) confirmed by ECG during spontaneous syncope. * If lacking ECG evidence during spontaneous syncope, a cardioinhibitory response (VASIS type 2A or 2B) on tilt test. * Displaying indicators for pacing such as those suggested in the ESC guidelines for a class I recommendation for patients with reflex syncope. * Significantly decreased quality of life due to syncope. * Sinus rhythm on ECGs. * Obtained written informed consent. Exclusion Criteria: * Intrinsic sinus or atrioventricular nodal disease with a proven indication for permanent pacemaker implantation. * Evidence of structural heart disease. * Contraindications to ablation in the right or left atrium. * Life expectancy \<12 months. * Lacking willingness to comply with the randomization procedure.
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What it tests

  • Cardioneuroablation
  • Permanent pacemaker therapy
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Where

10 sites
Hospital Universitario San Juan de Alicante
Sant Joan d'Alacant, Spain
Hospital Universitari General de Castellón
Castellon, Spain
Hospital Universitario Álvaro Cunqueiro de Vigo
Vigo, Spain
Hospital del Mar
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario de Bellvitge
Barcelona, Spain
Hospital Universitari Dr. Josep Trueta
Girona, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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