|

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

RECRUITINGN/ASponsored by Quovadis Associazione
Actively Recruiting
PhaseN/A
SponsorQuovadis Associazione
Started2022-07-27
Est. completion2028-12
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions3

Atrioventricular; Block, Second Degree (Types I and II)Heart DiseaseSinus Node Disease

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.