Conduction System PacingPHYSPAVBNCT05214365
Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy
A study testing Pacemaker implantation and conventional cardiac pacing and Conduction system pacing implant in people with Conduction System Pacing and Conventional Ventricular Pacing, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The implantation of a pacemaker and conventional cardiac pacing from the right ventricle (apex or septum) is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Conduction System Pacing, Conventional Ventricular Pacing
- What is being tested?
- Pacemaker implantation and conventional cardiac pacing and Conduction system pacing implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2022to 1 Dec 2026
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be ≥ 18 years of age.
- The patient must indicate their acceptance to participate in the study by signing an informed consent document.
- Patients with EF> 50% and indication for pacemaker implantation due to atrial-ventricular block according to current clinical guidelines.
Who cannot join
- Inability to understand and sign the informed consent.
- Patients with severe comorbidities and life expectancy <1 year.
- Patients with severe cognitive impairment or other comorbidities resulting in dependence for basic activities of daily life.
- Patients who cannot come to our center to carry out the follow-up of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Pacing vs.Conventional Pacing in the Prevention of Pacemaker-induced Cardiomyopathy: A Randomized Study
The implantation of a pacemaker and conventional cardiac pacing from the right ventricle (apex or septum) is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia.
Read the detailed description
Pacemaker implantation and conventional cardiac stimulation from the right ventricle is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia. But it can cause worsening of heart function, with a significant drop in LV ejection fraction, known as pacemaker-induced cardiomyopathy (PICM).
Conduction system pacing (either by his or left bundle branch pacing) causes a physiological left ventricular activation through the normal conduction system thus correcting the electrical and mechanical asynchrony caused by conventional pacing. Conduction system pacing may prevent the appareance of PICM.
Clinical, electrocardiographic, echocardiographic follow-up will be performed for 1 year.
- Being tested
- Pacemaker implantation and conventional cardiac pacing, Conduction system pacing implant
- Keywords
- Pacemaker-induced cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker implantation and conventional cardiac pacingDevice
Patients will have the pacemaker implanted in the electrophysiology laboratory. Electrode will be implanted (in the apical or septal portion) according to the criteria of the implanting physician.
Conduction system pacing implantDevice
Right ventricular lead was placed to get his bundle or left bundle branch.
| Study group | Role | What they receive |
|---|---|---|
| Conventional stimulation | Active comparator | An electrode (in the apical or septal portion) will be implanted at the discretion of the implanter physician. Parameters of (sensing, impedance and threshold) will be measured as is usually done in our center. Receives: Device: Pacemaker implantation and conventional cardiac pacing |
| Physiological stimulation | Active comparator | Pacing the his-purkinje system. Receives: Device: Conduction system pacing implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the incidence of pacemaker-induced heart disease
Pacemaker induced cardiomyopathy defined as appearance of ventricular dysfunction LVEF <45% or admission due to heart failure.
Measured: 12 months
Secondary outcomes (11)
Change in end-systolic volume.
VTSVI
Measured: 12 Months
Correction of septal flash.
Correction of septal flash determined with echocardiography (M mode)
Measured: 12 Months
Incidence of new onset of atrial fibrillation.
Measured: 12 Months
Hospitalization due to heart failure.
Hospitalization: patient hospitalization (yes/no)
Measured: 12 Months
New York Heart Association functional classification.
Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Measured: 12 Months
Pacing thresholds.
Pacing thresholds.
Measured: 12 Months
Total implantation and electrode implantation times.
Total implantation and electrode implantation times.
Measured: 12 Months
Adverse events.
Resulted in reintervention or the termination of significant device function
Measured: 12 Months
Six minute walking test.
Six minute walking test.
Measured: 12 Months
The Quality of Life Scale.
The Minnesota living with heart failure questionnaire. The most widely used health-related quality of life questionnaires for patients with heart failure. Values from 0 to 105 (more is worse).
Measured: 12 Months
NT-proBNP.
NT-proBNP measure
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Feb 2022
- Primary completion1 Sep 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduction System PacingStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, unicentric, simple blind.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigacions Biomèdiques August Pi i Sunyer, Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Responsible party
- Principal investigator, Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
- Investigators
- Jose M Tolosana, MD, PhD, Principal investigator, Hospital Clinic of BarcelonaLluís Mont, MD, PhD, Study director, Hospital Clinic of BarcelonaMargarida Pujol Lopez, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214365
- Sponsor's protocol ID
- PHYSPAVB
- Acronym
- PHYSPAVB
- Status last verified
- Oct 2026
- First submitted
- 17 Jan 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Pacing vs.Conventional Pacing in the Prevention of Pacemaker-induced Cardiomyopathy: A Randomized Study
- ClinicalTrials.gov ID
- NCT05214365
- Acronym / sponsor ID
- PHYSPAVB / PHYSPAVB
- Keywords
- Pacemaker-induced cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Institut d'Investigacions Biomèdiques August Pi i Sunyer, Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Jan 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.
The implantation of a pacemaker and conventional cardiac pacing from the right ventricle (apex or septum) is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia.
Detailed description
Pacemaker implantation and conventional cardiac stimulation from the right ventricle is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia. But it can cause worsening of heart function, with a significant drop in LV ejection fraction, known as pacemaker-induced cardiomyopathy (PICM).
Conduction system pacing (either by his or left bundle branch pacing) causes a physiological left ventricular activation through the normal conduction system thus correcting the electrical and mechanical asynchrony caused by conventional pacing. Conduction system pacing may prevent the appareance of PICM.
Clinical, electrocardiographic, echocardiographic follow-up will be performed for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, unicentric, simple blind.
| Arm | Type | Receives |
|---|---|---|
| Conventional stimulation | Active comparator | Device: Pacemaker implantation and conventional cardiac pacingAn electrode (in the apical or septal portion) will be implanted at the discretion of the implanter physician. Parameters of (sensing, impedance and threshold) will be measured as is usually done in our center. |
| Physiological stimulation | Active comparator | Device: Conduction system pacing implantPacing the his-purkinje system. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient must be ≥ 18 years of age.
- The patient must indicate their acceptance to participate in the study by signing an informed consent document.
- Patients with EF> 50% and indication for pacemaker implantation due to atrial-ventricular block according to current clinical guidelines.
Key exclusion criteria (4 listed)
- Inability to understand and sign the informed consent.
- Patients with severe comorbidities and life expectancy <1 year.
- Patients with severe cognitive impairment or other comorbidities resulting in dependence for basic activities of daily life.
- Patients who cannot come to our center to carry out the follow-up of the study.
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 |
|---|---|---|
| Pacemaker implantation and conventional cardiac pacingPatients will have the pacemaker implanted in the electrophysiology laboratory. Electrode will be implanted (in the apical or septal portion) according to the criteria of the implanting physician. | Device | Conventional stimulation |
| Conduction system pacing implantRight ventricular lead was placed to get his bundle or left bundle branch. | Device | Physiological stimulation |
Primary outcome
Compare the incidence of pacemaker-induced heart disease
Time frame: 12 months
Pacemaker induced cardiomyopathy defined as appearance of ventricular dysfunction LVEF <45% or admission due to heart failure.
11 secondary outcomes
Change in end-systolic volume.
Time frame: 12 Months
Correction of septal flash.
Time frame: 12 Months
Incidence of new onset of atrial fibrillation.
Time frame: 12 Months
Hospitalization due to heart failure.
Time frame: 12 Months
New York Heart Association functional classification.
Time frame: 12 Months
Pacing thresholds.
Time frame: 12 Months
Total implantation and electrode implantation times.
Time frame: 12 Months
Adverse events.
Time frame: 12 Months
Six minute walking test.
Time frame: 12 Months
The Quality of Life Scale.
Time frame: 12 Months
NT-proBNP.
Time frame: 12 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 15 Oct 2026.
- 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. This study is not recruiting at the moment.
Jose M Tolosana, MD, PhD principal investigator
Hospital Clinic of Barcelona
Lluís Mont, MD, PhD study director
Hospital Clinic of Barcelona
Margarida Pujol Lopez, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker implantation and conventional cardiac pacing and Conduction system pacing implant in people with Conduction System Pacing and Conventional Ventricular Pacing, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. 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 Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the incidence of pacemaker-induced heart disease (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.