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

NCT05367037 | Recruiting FDA Device

• 1 other identifier: PhysioVP-AF
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Sinus Node Disease; Paroxysmal AV-block; conduction system pacing; persistent atrial fibrillation

Outcome Measures

Primary Outcomes (2)

• PeAF Free

  Freedom from persistent AF occurrences up to 36 months after the pacemaker (PM) implant. The occurrence of PeAF is defined as the first AF / Atrial Flutter / Atrial Tachycardia episode lasting \> 7 days, detected by the PM after a 1-month post PM lead-stabilization period. A day of AF is satisfied with a device-detected daily AF burden of ≥ 23 hours. Device-detected AF may also be collected by remote monitoring tools, if available. The definition also includes the occurrence of episodes terminated by cardioversion, whatever its duration or undergoing AF ablation

  36 months

• Clinical composite outcome

  Composite outcome based on the occurrence of one or more of the events: Death from cardiovascular disease, or heart failure, or pacing system upgrading to the conduction system pacing (CSP) or to the biventricular pacing (BVP).

  36 months

Secondary Outcomes (17)

• Hemodynamic performance, LV remodeling 1

  12 months

• Hemodynamic performance, LV remodeling 2

  12 months

• Hemodynamic performance, Diastolic function 1

  12 months

• Hemodynamic performance, Diastolic function 2

  12 months

• Hemodynamic performance, Diastolic function 3

  12 months

Study Arms (2)

PhysioVP group

ACTIVE COMPARATOR

Physiological ventricular pacing

Device: PhysioVP

DDD-VPA group

ACTIVE COMPARATOR

Dual-chamber pacing with the addition of algorithms for ventricular pacing avoidance

Device: DDD-VPA

Interventions

PhysioVP DEVICE

The Physiological ventricular pacing is achieved by delivering a stimulus to a cardiac conduction structure, such as the bundle of His or left bundle branch of the His-Purkinje system, with a permanent lead. PhysioVP activates the heart through the native His-Purkinje conduction system, thus offering the most physiologic pacing approach to correct the PR interval and avoiding pacing-induced dyssynchrony. A specialized delivery sheath for His-Purkinje system pacing with appropriate or standard leads will be used. The atrial leads will be implanted in the right atrial appendage and will connect the leads to the standard dual-chamber PM. By continuously recording a 12-lead ECG, we determine whether cardiac conduction structure, such as the bundle of His or left bundle branch of the His-Purkinje system, will be achieved.

PhysioVP group

DDD-VPA DEVICE

In dual-chamber pacing with the addition of algorithms for ventricular pacing avoidance, also called managed ventricular pacing, the right ventricular (RV) lead is implanted in the myocardial right ventricular (septum or apex). In this pacing mode, the ventricular pacing is minimized by using algorithms for right ventricular pacing avoidance. Therefore, the RV leads will be implanted in the right ventricular myocardial sites (septum or apex) and standard bipolar active or passive fixation leads. In addition, the atrial leads will be implanted in the right atrial appendage and connect leads to the standard dual-chamber PM.

DDD-VPA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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.
• Participation in another clinical trial in the past 3 months.
• Pregnancy or intention to become pregnant.
• Life expectancy of \< 3 years.

Sponsors & Collaborators

• Quovadis Associazione: lead

Study Sites (1)

Elettrofisiologia, Cardiologia, Ospedale di Rovigo

Rovigo, Veneto, 45100, Italy

RECRUITING

Related Publications (1)

• Pastore G, Bertini M, Bonanno C, Coluccia G, Dell'Era G, De Mattia L, Grieco D, Katsouras G, Maines M, Marcantoni L, Marinaccio L, Paglino G, Palmisano P, Ziacchi M, Zoppo F, Noventa F. 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. Europace. 2023 May 19;25(5):euad082. doi: 10.1093/europace/euad082.

  PMID: 36974970 BACKGROUND

Related Links

• Promotor's site

MeSH Terms

Conditions

Sick Sinus Syndrome; Bites and Stings; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Gianni Pastore, MD

  Cardiology Unit, "S.Maria della Misericordia" Hospital, Rovigo, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianni Pastore, MD

CONTACT

‭+39 (339) 754-4514‬; gianni.pastore@aulss5.veneto.it

Franco Noventa, MD

CONTACT

franco.noventa@quovadis-ass.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: single-blind with double-blind evaluation (the actual evaluator of the primary endpoint is the pacemaker device's internal diagnostic algorithm, without intervention by the Investigator)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a prospective, randomized study in a 1:1 ratio, single-blind with double-blind evaluation (the actual evaluator of the primary endpoint is the pacemaker device's internal diagnostic algorithm, without intervention by the Investigator)

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: May 10, 2022
• Study Start: July 27, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)