Comparing two pacing methods to prevent persistent atrial fibrillation
Physiological Ventricular Pacing Versus Managed Ventricular Pacing for Persistent Atrial Fibrillation Prevention in Patients With Prolonged Atrioventricular Interval: a Multicenter RCT
This study is testing whether a new way of pacing the heart can help people with certain heart conditions avoid long-term atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 640 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Quovadis Associazione Academic / other |
| Locations | 1 site (Rovigo, Veneto) |
| Trial ID | NCT05367037 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 and older with prolonged atrioventricular intervals and indications for pacemaker implantation due to sinus node disease or paroxysmal second-degree AV block.
Not a fit: Patients who may not benefit include those with severe valvular heart disease, a history of long-standing persistent atrial fibrillation, or those requiring other cardiac devices.
Why it matters
Potential benefit: If successful, this study could provide a more effective pacing method that reduces the risk of persistent atrial fibrillation in patients with specific heart conditions.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving pacing techniques, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rovigo, Veneto
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.