Cardioneuroablation in Reflex Syncope (CARDIOSYRE Trial)

Launched by FUNDACIÓN DE INVESTIGACIÓN HM · Aug 22, 2022

Keywords

ClinConnect Summary

The CARDIOSYRE Trial is studying a new treatment called cardioneuroablation for people with a condition known as reflex syncope. Reflex syncope can cause fainting spells that may lead to serious injuries, and currently, there are no effective long-term treatments available. In this trial, researchers aim to compare the effects of cardioneuroablation, which targets specific nerves in the heart, to conventional treatments like lifestyle changes and medications. The study will include 92 participants across 15 medical centers from June 2022 to June 2025.

To be eligible for this trial, participants must be aged 18 or older and have experienced at least two fainting episodes in the past year, with specific heart response patterns documented. Not everyone will qualify; for example, those with certain heart conditions or who are taking part in other clinical trials cannot join. Participants will be randomly assigned to either receive the new treatment or continue with standard care, and they will be monitored for changes in their fainting episodes over the next year. This study hopes to provide valuable insights into whether this new approach can help reduce fainting spells and improve quality of life for those affected by reflex syncope.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with reflex syncope (two or more episodes in the last year) and cardioinhibitory response (documentation of asystole \>3 seconds coinciding with syncope or \>6 seconds outside of syncope or cardioinhibitory response on the tilt test) defined such as heart rate \< 40 bpm for at least 10 seconds or asystolic pause \> 3 seconds
• Exclusion Criteria:
• • Patients under 18 years
• • Any pathology or medical condition that limits survival to less than one year;
• • Illegal drug use, chronic alcoholism, or total alcohol use \>80 g/d
• • Participation in a clinical trial conducted with drugs or use of a drug in an experimental state during the year prior to inclusion
• • Patients institutionalized for chronic treatment, with a lack of autonomy and with the impossibility of carrying out clinical follow-ups
• • Patients with pacemakers, patients with intrinsic disease of the cardiac conduction system or bundle branch block
• • Patients with structural heart disease.