Sinus Node DiseasePhysioVP-AFNCT05367037
Physiological Ventricular Pacing Vs Managed Ventricular Pacing for Persistent AF Prevention in Prolonged AV Interval
A study testing PhysioVP and DDD-VPA in people with Sinus Node Disease and Atrioventricular; Block, Second Degree (Types I and II), run by Quovadis Associazione at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Node Disease, Atrioventricular; Block, Second Degree (Types I and II)
- What is being tested?
- PhysioVP and DDD-VPA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jul 2022to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- 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.
Show all 9Show fewer
- Participation in another clinical trial in the past 3 months.
- Pregnancy or intention to become pregnant.
- Life expectancy of < 3 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Franco Noventa, MD contact
Italy1 site, 1 recruiting
- Recruiting
Elettrofisiologia, Cardiologia, Ospedale di Rovigo
Rovigo, Veneto, 45100
Gianni Pastore, MD, gianni.pastore@aulss5.veneto.it
Gianni Pastore, MD
About this study
Official title: Physiological Ventricular Pacing Versus Managed Ventricular Pacing for Persistent Atrial Fibrillation Prevention in Patients With Prolonged Atrioventricular Interval: a Multicenter RCT
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.
Read the detailed description
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:
- PhysioVP group: the Physiological Ventricular Pacing is achieved by delivering a pacing 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.
- DDD-VPA group: In 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.
Devices used:
- PhysioVP group: a specialized delivery sheath for His-Purkinje system pacing with appropriate or standard leads will be used.
- DDD-VPA group: the RV leads will be implanted in the standard right ventricular myocardial sites (septum or apex) using standard bipolar active-fixation leads.
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.
- Being tested
- PhysioVP, DDD-VPA
- Keywords
- Sinus Node Disease, Paroxysmal AV-block, conduction system pacing, persistent atrial fibrillation
- Medical subject headings
- Sick Sinus Syndrome, Bites and Stings, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysioVPDevice
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-VPADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PhysioVP group | Active comparator | Physiological ventricular pacing Receives: Device: PhysioVP |
| DDD-VPA group | Active comparator | Dual-chamber pacing with the addition of algorithms for ventricular pacing avoidance Receives: Device: DDD-VPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 36 months
Secondary outcomes (17)
Hemodynamic performance, LV remodeling 1
Echocardiographic parameters: Left Ventriculi end-systolic volume (ml/m2).
Measured: 12 months
Hemodynamic performance, LV remodeling 2
Echocardiographic parameters: LVEF (%).
Measured: 12 months
Hemodynamic performance, Diastolic function 1
Echocardiographic parameters: E to A mitral wave amplitude ratio.
Measured: 12 months
Hemodynamic performance, Diastolic function 2
Echocardiographic parameters: E wave deceleration time (ms).
Measured: 12 months
Hemodynamic performance, Diastolic function 3
Echocardiographic parameters: pulsed-wave tissue Doppler early diastolic septal mitral annular velocity (e') (cm/s).
Measured: 12 months
Hemodynamic performance, Diastolic function 4
Echocardiographic parameters: E/e' ratio.
Measured: 12 months
Hemodynamic performance, Diastolic function 5
Echocardiographic parameters: Diastolic time (from onset E wave to end A wave) normalized for RR interval (ms).
Measured: 12 months
Hemodynamic performance, Left atrial volume
Echocardiographic parameters: Left atrial volume (ml/m2).
Measured: 12 months
Hemodynamic performance, Mitral regurgitation
Echocardiographic parameters: vena contracta (mm).
Measured: 12 months
Clinical evaluations, NYHA
NYHA class variation (I, II, III, IV).
Measured: 12, 24, and 36 months
Clinical evaluations, MLHFQ
Variation of Quality-of-Life assessment by Minnesota Living with Heart Failure questionnaire (MLHFQ).
Measured: 12, 24, and 36 months
Clinical evaluations
Number of cardiovascular diseases related to health structure access.
Measured: 12, 24, and 36 months
Safety endpoints, PRAE
Rate of all procedure-related adverse events (PRAE).
Measured: 36 months
Safety endpoints, Potentially harmful factor 1
Implantation/s procedure time (mm:ss).
Measured: 36 months
Safety endpoints, Potentially harmful factor 2
Fluoroscopy time (mm:ss).
Measured: 36 months
Safety endpoints, Incidence Rate of re-interventions
Rate of re-interventions for lead revision, replacement, or infection.
Measured: 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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start27 Jul 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sinus Node DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quovadis Associazione
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianni Pastore, MD, Principal investigator, Cardiology Unit, "S.Maria della Misericordia" Hospital, Rovigo, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367037
- Sponsor's protocol ID
- PhysioVP-AF
- Acronym
- PhysioVP-AF
- Status last verified
- May 2025
- First submitted
- 12 Jan 2022
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36974970
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Ventricular Pacing Versus Managed Ventricular Pacing for Persistent Atrial Fibrillation Prevention in Patients With Prolonged Atrioventricular Interval: a Multicenter RCT
- ClinicalTrials.gov ID
- NCT05367037
- Acronym / sponsor ID
- PhysioVP-AF / PhysioVP-AF
- Keywords
- Sinus Node Disease, Paroxysmal AV-block, conduction system pacing, persistent atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Quovadis AssociazioneUniversity, hospital or other
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- PhysioVP group: the Physiological Ventricular Pacing is achieved by delivering a pacing 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.
- DDD-VPA group: In 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.
Devices used:
- PhysioVP group: a specialized delivery sheath for His-Purkinje system pacing with appropriate or standard leads will be used.
- DDD-VPA group: the RV leads will be implanted in the standard right ventricular myocardial sites (septum or apex) using standard bipolar active-fixation leads.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| PhysioVP group | Active comparator | Device: PhysioVPPhysiological ventricular pacing |
| DDD-VPA group | Active comparator | Device: DDD-VPADual-chamber pacing with the addition of algorithms for ventricular pacing avoidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysioVPThe 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 | PhysioVP group |
| DDD-VPAIn 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. | Device | DDD-VPA group |
Primary outcome
PeAF Free
Time frame: 36 months
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
Clinical composite outcome
Time frame: 36 months
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).
17 secondary outcomes
Hemodynamic performance, LV remodeling 1
Time frame: 12 months
Hemodynamic performance, LV remodeling 2
Time frame: 12 months
Hemodynamic performance, Diastolic function 1
Time frame: 12 months
Hemodynamic performance, Diastolic function 2
Time frame: 12 months
Hemodynamic performance, Diastolic function 3
Time frame: 12 months
Hemodynamic performance, Diastolic function 4
Time frame: 12 months
Hemodynamic performance, Diastolic function 5
Time frame: 12 months
Hemodynamic performance, Left atrial volume
Time frame: 12 months
Hemodynamic performance, Mitral regurgitation
Time frame: 12 months
Clinical evaluations, NYHA
Time frame: 12, 24, and 36 months
Clinical evaluations, MLHFQ
Time frame: 12, 24, and 36 months
Clinical evaluations
Time frame: 12, 24, and 36 months
Safety endpoints, PRAE
Time frame: 36 months
Safety endpoints, Potentially harmful factor 1
Time frame: 36 months
Safety endpoints, Potentially harmful factor 2
Time frame: 36 months
Safety endpoints, Incidence Rate of re-interventions
Time frame: 36 months
Estimated battery longevity
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Results publication: PubMed 36974970Pastore 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.
- Promotor's siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Franco Noventa, MD contact
Gianni Pastore, MD principal investigator
Cardiology Unit, "S.Maria della Misericordia" Hospital, Rovigo, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PhysioVP and DDD-VPA in people with Sinus Node Disease and Atrioventricular; Block, Second Degree (Types I and II), run by Quovadis Associazione at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianni Pastore, MD (+39 (339) 754-4514, gianni.pastore@aulss5.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PeAF Free (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05367037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.