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Compares treatment options for Sinus Node Disease
Official title Physiological Ventricular Pacing Vs Managed Ventricular Pacing for Persistent AF Prevention in Prolonged AV Interval
ClinicalTrials.gov ID: NCT05367037
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years older patients, able to express Informed Consent, with prolonged atrioventricular interval (PR\>180 ms) and one of the following indications...
- Sinus node disease.
- Paroxysmal type1or 2 second-degree AV-block.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rovigo, Veneto, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rovigo, Veneto, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.