NCT05367037Recruiting
Physiological Ventricular Pacing Vs Managed Ventricular Pacing for Persistent AF Prevention in Prolonged AV Interval
Physiological Ventricular Pacing Versus Managed Ventricular Pacing for Persistent Atrial Fibrillation Prevention in Patients With Prolonged Atrioventricular Interval: a Multicenter RCT
Source: ClinicalTrials.gov · Last updated 11 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 640 (estimated)
- First submitted
- 12 Jan 2022
- Start date
- 27 Jul 2022
- Primary completion date
- Dec 2028
- Lead sponsor
- Quovadis Associazione
- Diseases
- Atrial fibrillation
- NCT number
- NCT05367037
What you commit to
- Study type: Interventional
- Planned participants: 640
- From 27 Jul 2022 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cardiac surgery \< 3 months before PM implantation.
Other illness
- Candidacy for implantable cardioverter-defibrillator or cardiac resynchronization therapy device implantation.
- History of long-standing persistent AF.
Age
- Life expectancy of \< 3 years.
Other
- Severe grade mitral or aortic regurgitation/stenosis.
- Atrial fibrillation ablation (left pulmonary veins).
- Permanent third-degree AV block.
- Participation in another clinical trial in the past 3 months.
- Pregnancy or intention to become pregnant.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Elettrofisiologia, Cardiologia, Ospedale di Rovigo Coordinator of this site? Confirm its status | Rovigo | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.