An interventional study of PhysioVP and DDD-VPA in Sinus Node Disease and Atrioventricular; Block, Second Degree (Types I and II), sponsored by Quovadis Associazione. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Quovadis Associazione · Not applicable, Interventional, and Prevention
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.
Study aim: 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. If the efficacy superiority is confirmed, this pacing mode may be considered to reduce the occurrence of persistent atrial fibrillation in this group of patients.
Study design: Independent, multicenter, 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). This study will use only CE-marked devices already part of clinical practice.
Groups:
Devices used:
The atrial leads will be placed in the right atrial appendage in both groups. The 13 participating Italian Clinical Centers are proven experience in the PM implantation procedures used in the study.
Enrolled patients will be monitored by in-office clinical checks at 1, 12, 24, and 36 months and by home monitoring at 6, 18, and 30 months after implantation.
93 studies on the registry are indexed under Sick Sinus Syndrome; 18 are open to participants now.
This study's planned enrollment of 640 is above the median of 137 across 62 interventional studies indexed under Sick Sinus Syndrome.
Browse Sick Sinus Syndrome studies →Quovadis Associazione is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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18 years older patients, able to express , with prolonged atrioventricular interval (PR>180 ms) and one of the following indications for PM implantation according to current guidelines:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Physiological ventricular pacing
Device: PhysioVP
Dual-chamber pacing with the addition of algorithms for ventricular pacing avoidance
Device: DDD-VPA
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.
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.
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
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
Hemodynamic performance, LV remodeling 1
Echocardiographic parameters: Left Ventriculi end-systolic volume (ml/m2).
Time frame: 12 months
Hemodynamic performance, LV remodeling 2
Echocardiographic parameters: LVEF (%).
Time frame: 12 months
Hemodynamic performance, Diastolic function 1
Echocardiographic parameters: E to A mitral wave amplitude ratio.
Time frame: 12 months
Hemodynamic performance, Diastolic function 2
Echocardiographic parameters: E wave deceleration time (ms).
Time frame: 12 months
Hemodynamic performance, Diastolic function 3
Echocardiographic parameters: pulsed-wave tissue Doppler early diastolic septal mitral annular velocity (e') (cm/s).
Time frame: 12 months
Hemodynamic performance, Diastolic function 4
Echocardiographic parameters: E/e' ratio.
Time frame: 12 months
Hemodynamic performance, Diastolic function 5
Echocardiographic parameters: Diastolic time (from onset E wave to end A wave) normalized for RR interval (ms).
Time frame: 12 months
Hemodynamic performance, Left atrial volume
Echocardiographic parameters: Left atrial volume (ml/m2).
Time frame: 12 months
Hemodynamic performance, Mitral regurgitation
Echocardiographic parameters: vena contracta (mm).
Time frame: 12 months
Clinical evaluations, NYHA
NYHA class variation (I, II, III, IV).
Time frame: 12, 24, and 36 months
Clinical evaluations, MLHFQ
Variation of Quality-of-Life assessment by Minnesota Living with Heart Failure questionnaire (MLHFQ).
Time frame: 12, 24, and 36 months
Clinical evaluations
Number of cardiovascular diseases related to health structure access.
Time frame: 12, 24, and 36 months
Safety endpoints, PRAE
Rate of all procedure-related adverse events (PRAE).
Time frame: 36 months
Safety endpoints, Potentially harmful factor 1
Implantation/s procedure time (mm:ss).
Time frame: 36 months
Safety endpoints, Potentially harmful factor 2
Fluoroscopy time (mm:ss).
Time frame: 36 months
Safety endpoints, Incidence Rate of re-interventions
Rate of re-interventions for lead revision, replacement, or infection.
Time frame: 36 months
Estimated battery longevity
Estimated residual battery longevity (time to end-of-life) by the implanted device every 6-months and/or when the primary endpoint is reached.
Time frame: 36 months
Plan to share: No
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