Physiological Ventricular Pacing Versus Managed Ventricular Pacing for Persistent Atrial Fibrillation Prevention in Patients With Prolonged Atrioventricular Interval: a Multicenter RCT
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
A multicenter, prospective, randomized study in a 1:1 ratio, single-blind with double-blind evaluation to evaluate the superiority of physiological ventricular pacing (proposed modality) vs. managed ventricular pacing (control) for prevention of persistent AF (PeAF) occurrence in patients with prolonged atrioventricular interval (PR≥180 ms) and indication for pacing: sinus node disease and/or paroxysmal type 1 or 2-second degree AV block.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 18 years older patients, able to express Informed Consent, with prolonged atrioventricular interval (PR\>180 ms) and one of the following indications for PM implantation according to current guidelines:
• Sinus node disease.
• Paroxysmal type1or 2 second-degree AV-block.
Locations
Other Locations
Italy
Elettrofisiologia, Cardiologia, Ospedale di Rovigo
RECRUITING
Rovigo
Contact Information
Primary
Gianni Pastore, MD
gianni.pastore@aulss5.veneto.it
+39 (339) 754-4514
Backup
Franco Noventa, MD
franco.noventa@quovadis-ass.it
Time Frame
Start Date: 2022-07-27
Estimated Completion Date: 2028-12
Participants
Target number of participants: 640
Treatments
Active_comparator: PhysioVP group
Physiological ventricular pacing
Active_comparator: DDD-VPA group
Dual-chamber pacing with the addition of algorithms for ventricular pacing avoidance
Related Therapeutic Areas
Sponsors
Leads: Quovadis Associazione