Physiological Ventricular Pacing Vs Managed Ventricular Pacing for Persistent AF Prevention in Prolonged AV Interval
Recruiting · NCT05367037 · Interventional (participants receive a specific treatment) · Lead sponsor: Quovadis Associazione
View the official record on ClinicalTrials.gov →Interventions studied
DDD-VPAPhysioVP
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 is running
1 location listed.
- Elettrofisiologia, Cardiologia, Ospedale di Rovigo - Rovigo, Veneto, Italy