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

NARecruitingINTERVENTIONAL
Enrollment

640

Participants

Timeline

Start Date

July 27, 2022

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Sinus Node DiseaseAtrioventricular; Block, Second Degree (Types I and II)
Interventions
DEVICE

PhysioVP

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.

DEVICE

DDD-VPA

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.

Trial Locations (1)

45100

RECRUITING

Elettrofisiologia, Cardiologia, Ospedale di Rovigo, Rovigo

All Listed Sponsors
lead

Quovadis Associazione

OTHER