Key result
The PhysioVP-AF trial will randomize approximately 400 patients to determine if atrial-synchronized conduction system pacing is superior to standard DDD-VPA pacing for preventing persistent AF.
Why the study?
The clinical benefit of ventricular pacing avoidance algorithms over DDD/DDDR pacing is controversial in patients with prolonged AV conduction and pacemaker indication, possibly due to algorithm-induced PR prolongation.
Does atrial-synchronized conduction system pacing reduce the occurrence of persistent atrial fibrillation compared to standard ventricular pacing avoidance algorithms in patients with prolonged AV conduction and pacemaker indication?
RCT (n=400)
Single-blind
1:1
Yes
Does atrial-synchronized conduction system pacing reduce the occurrence of persistent atrial fibrillation compared to standard ventricular pacing avoidance algorithms in patients with prolonged AV conduction and pacemaker indication?
Answers are grounded in this paper and cite their sources.
The PhysioVP-AF study protocol is designed to determine if conduction system pacing with a controlled PR interval is superior to standard ventricular pacing avoidance algorithms in preventing persistent atrial fibrillation.
AIMS: In patients with prolonged atrioventricular (AV) conduction and pacemaker (PM) indication due to sinus node disease (SND) or intermittent AV-block who do not need continuous ventricular pacing (VP), it may be difficult to determine which strategy to adopt. Currently, the standard of care is to minimize unnecessary VP by specific VP avoidance (VPA) algorithms. The superiority of this strategy over standard DDD or DDD rate-responsive (DDD/DDDR) in improving clinical outcomes is controversial, probably owing to the prolongation of the atrialventricular conduction (PR interval) caused by the algorithms. Conduction system pacing (CSP) may offer the most physiological-VP approach, providing appropriate AV conduction and preventing pacing-induced dyssynchrony. METHODS AND RESULTS: PhysioVP-AF is a prospective, controlled, randomized, single-blind trial designed to determine whether atrial-synchronized conduction system pacing (DDD-CSP) is superior to standard DDD-VPA pacing in terms of 3-year reduction of persistent-AF occurrence. Cardiovascular hospitalization, quality-of-life, and safety will be evaluated. Patients with indication for permanent DDD pacing for SND or intermittent AV-block and prolonged AV conduction (PR interval > 180 ms) will be randomized (1:1 ratio) to DDD-VPA (VPA-algorithms ON, septal/apex position) or to DDD-CSP (His bundle or left bundle branch area pacing, AV-delay setting to control PR interval, VPA-algorithms OFF). Approximately 400 patients will be randomized in 24 months in 13 Italian centres. CONCLUSION: The PhysioVP-AF study will provide an essential contribution to patient management with prolonged AV conduction and PM indication for sinus nodal disease or paroxysmal 2nd-degree AV-block by determining whether CSP combined with a controlled PR interval is superior to standard management that minimizes unnecessary VP in terms of reducing clinical outcomes.
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Pastore et al. (2023) conducted an RCT in Prolonged atrioventricular conduction and pacemaker indication (n=400). Atrial-synchronized conduction system pacing (DDD-CSP) vs. Standard DDD-VPA pacing was evaluated on Persistent atrial fibrillation occurrence at 3 years. The PhysioVP-AF trial will randomize approximately 400 patients to determine if atrial-synchronized conduction system pacing is superior to standard DDD-VPA pacing for preventing persistent AF.
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