RecruitingNot ApplicableNCT05367037

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

Physiological Ventricular Pacing Versus Managed Ventricular Pacing for Persistent Atrial Fibrillation Prevention in Patients With Prolonged Atrioventricular Interval: a Multicenter RCT


Sponsor

Quovadis Associazione

Enrollment

640 participants

Start Date

Jul 27, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two pacemaker programming methods to prevent atrial fibrillation (an irregular heart rhythm) in patients who need a pacemaker and have a prolonged PR interval (a delayed electrical signal from the top to the bottom of the heart). Researchers want to know which type of pacing best prevents AF from developing. **You may be eligible if...** - You are 18 or older - You need a pacemaker for a heart rhythm problem (sick sinus syndrome or certain types of heart block) - You have a prolonged PR interval (above 180 milliseconds on your ECG) **You may NOT be eligible if...** - You need a defibrillator or cardiac resynchronization device - You have severe heart valve disease (mitral or aortic) - You have had AF ablation (pulmonary vein isolation) - You had heart surgery within the last 3 months - You have a history of long-standing persistent or permanent atrial fibrillation - You have third-degree (complete) heart block - You are pregnant or planning to become pregnant - Your life expectancy is less than 3 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPhysioVP

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.

DEVICEDDD-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.


Locations(1)

Elettrofisiologia, Cardiologia, Ospedale di Rovigo

Rovigo, Veneto, Italy

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NCT05367037


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