Physiological Ventricular Pacing Vs Managed Ventricular Pacing for Persistent AF Prevention in Prolonged AV Interval

Recruiting now · Not applicable

Conditions studied: Sinus Node Disease, Atrioventricular; Block, Second Degree (Types I and II)

In brief

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.

Key facts

Study ID: NCT05367037
Run by: Quovadis Associazione
People needed: 640
Starts: 2022-07-27
Expected to finish: 2028-12-01
Last updated by the study team: 2025-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Elettrofisiologia, Cardiologia, Ospedale di Rovigo — Rovigo, Veneto, Italy (enrolling)

Full record on ClinicalTrials.gov

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