Comparing two pacing methods to prevent persistent atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, randomized study aims to evaluate the effectiveness of physiological ventricular pacing compared to managed ventricular pacing in preventing persistent atrial fibrillation in patients with prolonged atrioventricular intervals. Participants will be randomly assigned to one of the two pacing methods, with the primary endpoint assessed by the pacemaker's internal diagnostic algorithm. The study focuses on patients with sinus node disease or paroxysmal second-degree AV block who require pacing. If successful, this approach could significantly reduce the occurrence of persistent atrial fibrillation in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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 Criteria:

* 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's running

• Elettrofisiologia, Cardiologia, Ospedale di Rovigo
  Rovigo, Veneto, Italy Recruiting

Study contacts

• Principal investigator: Gianni Pastore, MD — Cardiology Unit, "S.Maria della Misericordia" Hospital, Rovigo, Italy
• Study coordinator: Gianni Pastore, MD
• Email: gianni.pastore@aulss5.veneto.it
• Phone: ‭+39 (339) 754-4514‬

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.