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

ConditionsSinus Node DiseaseAtrioventricular; Block, Second Degree (Types I and II)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQuovadis Associazione

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Sinus node disease.

Paroxysmal type1or 2 second-degree AV-block.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

640 Participants
are divided into 2 treatment groups
Group A: PhysioVP groupActive comparator 1 intervention
Group B: DDD-VPA groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
36 months
2

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).

Time frame
36 months

Secondary outcomes

1

Hemodynamic performance, LV remodeling 1

Echocardiographic parameters: Left Ventriculi end-systolic volume (ml/m2).

Time frame
12 months
2

Hemodynamic performance, LV remodeling 2

Echocardiographic parameters: LVEF (%).

Time frame
12 months
3

Hemodynamic performance, Diastolic function 1

Echocardiographic parameters: E to A mitral wave amplitude ratio.

Time frame
12 months
4

Hemodynamic performance, Diastolic function 2

Echocardiographic parameters: E wave deceleration time (ms).

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Quovadis Associazione

Lead sponsor

Source ClinicalTrials.gov
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