Physiological Ventricular Pacing Vs Managed Ventricular Pacing for Persistent AF Prevention in Prolonged AV Interval
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQuovadis Associazione
About this trial
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 criteria
Qualifiers
Sinus node disease.
Paroxysmal type1or 2 second-degree AV-block.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- PhysioVP
- DDD-VPA
Treatment groups
640 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov