Phase
Condition
Dizzy/fainting Spells
Low Blood Pressure (Hypotension)
Orthostatic Hypotension
Treatment
Permanent pacemaker therapy
Cardioneuroablation
Clinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged more than 40 years.
- Having a 12-month history that includes at least two documented episodes ofspontaneous reflex syncope or one episode that led to injury in addition to at leasttwo presyncopal events, refractory to all recommended types of standard treatment.
- Bradycardia-syncope correlation (at least 3 seconds of asystole due to sinus arrest oratrio-ventricular block) confirmed by ECG during spontaneous syncope.
- If lacking ECG evidence during spontaneous syncope, a cardioinhibitory response (VASIStype 2A or 2B) on tilt test.
- Displaying indicators for pacing such as those suggested in the ESC guidelines for aclass I recommendation for patients with reflex syncope.
- Significantly decreased quality of life due to syncope.
- Sinus rhythm on ECGs.
- Obtained written informed consent.
Exclusion
Exclusion Criteria:
- Intrinsic sinus or atrioventricular nodal disease with a proven indication forpermanent 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.
Study Design
Study Description
Connect with a study center
Hospital Universitario San Juan de Alicante
San Juan De Alicante, Alicante 03550
SpainSite Not Available
Hospital Universitari General de Castellón
Castellón De La Plana, Castellón 12004
SpainSite Not Available
Hospital Universitario Álvaro Cunqueiro de Vigo
Vigo, Pontevedra 36312
SpainSite Not Available
Hospital Universitario de Bellvitge
Barcelona, 08907
SpainActive - Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
SpainSite Not Available
Hospital del Mar
Barcelona, 08003
SpainSite Not Available
Hospital Universitari Dr. Josep Trueta
Girona, 17007
SpainSite Not Available
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010
SpainSite Not Available
Hospital Universitari i Politècnic La Fe
Valencia, 46026
SpainSite Not Available
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
SpainSite Not Available
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