Status:
RECRUITING
Physiological Ventricular Pacing Vs Managed Ventricular Pacing for Persistent AF Prevention in Prolonged AV Interval
Lead Sponsor:
Quovadis Associazione
Conditions:
Sinus Node Disease
Atrioventricular; Block, Second Degree (Types I and II)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 v...
Detailed Description
Study aim: Evaluate the superiority of physiological ventricular pacing (proposed modality) vs. managed ventricular pacing (control) for prevention of persistent AF (PeAF) occurrence in patients with ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Candidacy for implantable cardioverter-defibrillator or cardiac resynchronization therapy device implantation.
- Severe grade mitral or aortic regurgitation/stenosis.
- Atrial fibrillation ablation (left pulmonary veins).
- Cardiac surgery \< 3 months before PM implantation.
- History of long-standing persistent AF.
- Permanent third-degree AV block.
- Participation in another clinical trial in the past 3 months.
- Pregnancy or intention to become pregnant.
- Life expectancy of \< 3 years.
Key Trial Info
Start Date :
July 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT05367037
Start Date
July 27 2022
End Date
December 1 2028
Last Update
May 11 2025
Active Locations (1)
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1
Elettrofisiologia, Cardiologia, Ospedale di Rovigo
Rovigo, Veneto, Italy, 45100