Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05367037

Physiological Ventricular Pacing Versus Managed Ventricular Pacing for Persistent Atrial Fibrillation Prevention in Patients With Prolonged Atrioventricular Interval: a Multicenter RCT

Led by Quovadis Associazione · Updated on 2025-05-11

640

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the superiority of physiological ventricular pacing compared to managed ventricular pacing for preventing persistent atrial fibrillation in patients who have a prolonged atrioventricular interval and require pacing due to sinus node disease or certain types of second-degree atrioventricular block. This multicenter, prospective, randomized trial uses CE-marked devices already in clinical practice to compare these pacing methods. The study involves two groups: one receiving physiological ventricular pacing (PhysioVP), which delivers stimulation to the heart's natural conduction system to correct the PR interval and avoid dyssynchrony, and the other receiving managed ventricular pacing (DDD-VPA), which uses right ventricular leads and algorithms to minimize ventricular pacing. Both groups receive atrial leads placed in the right atrial appendage. Patients are implanted with dual-chamber pacemakers and monitored over time. Participants will have in-office clinical checks at 1, 12, 24, and 36 months after implantation, with additional home monitoring at 6, 18, and 30 months. Researchers will measure outcomes such as the occurrence of persistent atrial fibrillation and clinical composite outcomes over 36 months. Secondary measures include heart function, remodeling, and safety endpoints. The study continues monitoring for three years to evaluate the pacing methods' impact.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Able to give informed consent
  • Prolonged atrioventricular interval (PR >180 ms)
  • Indication for pacemaker implantation due to sinus node disease
  • Indication for pacemaker implantation due to paroxysmal type 1 or 2 second-degree AV block
Not Eligible

You will not qualify if you...

  • Candidates for implantable cardioverter-defibrillator or cardiac resynchronization therapy device implantation
  • Severe mitral or aortic valve regurgitation or stenosis
  • Previous atrial fibrillation ablation involving left pulmonary veins
  • Cardiac surgery within 3 months before pacemaker implantation
  • History of long-standing persistent atrial fibrillation
  • Permanent third-degree atrioventricular block
  • Participation in another clinical trial within the past 3 months
  • Pregnancy or intention to become pregnant
  • Life expectancy less than 3 years

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - 1 day

Participants undergo implantation of pacing devices with either physiological ventricular pacing leads or managed ventricular pacing leads placed in the heart.

1 implantation visit (in-person)

Post-implantation Monitoring

Duration - 36 months

Participants are monitored through clinical visits and home monitoring to assess the effectiveness and safety of the pacing devices in preventing persistent atrial fibrillation.

In-office visits at 1, 12, 24, and 36 months and home monitoring at 6, 18, and 30 months

Trial Site Locations

Total: 1 location

1

Elettrofisiologia, Cardiologia, Ospedale di Rovigo

Rovigo, Veneto, Italy, 45100

Actively Recruiting

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Research Team

G

Gianni Pastore, MD

F

Franco Noventa, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

The PhysioVP-AF study, a randomized controlled trial to assess the clinical benefit of physiological ventricular pacing vs. managed ventricular pacing for persistent atrial fibrillation prevention in patients with prolonged atrioventricular conduction: design and rationale.

Gianni Pastore, Matteo Bertini, Carlo Bonanno...

https://pubmed.ncbi.nlm.nih.gov/36974970