Pacing Method Tested to Prevent Persistent Atrial Fibrillation in Heart Rhythm Patients
Compares two heart pacing methods in adults with sinus node disease or AV block.
Key facts
- Who runs it
- Quovadis Associazione
- Where
- Rovigo, ItalySee the site
- Trial code
- Registry title
- Physiological Ventricular Pacing Vs Managed Ventricular Pacing for Persistent AF Prevention in Prolonged AV Interval
- Status
- Recruiting
- People taking part
- 640 people, planned
- Started
- 27 Jul 2022
- Expected to end
- Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- PhysioVP
- DDD-VPA
- Record updated
- 11 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who need a pacemaker for sinus node disease or intermittent second-degree AV block, and who have a prolonged PR interval.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Prolonged atrioventricular interval (PR>180 ms) and a pacemaker indication: sinus node disease or paroxysmal type 1 or 2 second-degree AV block.
- Earlier treatment
- No cardiac surgery in the 3 months before pacemaker implantation; no atrial fibrillation ablation of the left pulmonary veins.
Main reasons for not taking part
- Needs an implantable cardioverter-defibrillator or cardiac resynchronization therapy device
- Severe mitral or aortic valve regurgitation or stenosis
- History of long-standing persistent atrial fibrillation
- Permanent third-degree AV block
- Pregnant or planning to become pregnant
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Cardiac surgery < 3 months before PM implantation
- Candidacy for implantable cardioverter-defibrillator or cardiac resynchronization therapy device implantation
- History of long-standing persistent AF
- Life expectancy of < 3 years
- 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
Where in Italy
- Elettrofisiologia, Cardiologia, Ospedale di RovigoRovigo, ItalyContact: Gianni Pastore, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- PhysioVP groupExisting treatment, for comparison
Physiological ventricular pacing
Treatment: PhysioVP
- DDD-VPA groupExisting treatment, for comparison
Dual-chamber pacing with the addition of algorithms for ventricular pacing avoidance
Treatment: DDD-VPA
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Physiological Ventricular Pacing Versus Managed Ventricular Pacing for Persistent Atrial Fibrillation Prevention in Patients With Prolonged Atrioventricular Interval: a Multicenter RCT
- Plain-language title
- Pacing Method Tested to Prevent Persistent Atrial Fibrillation in Heart Rhythm PatientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 11 May 2025