Transcatheter Aortic Valve ImplantationPHYSTAVIIINCT06197503
Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI
A study testing Conduction system pacing and Right ventricular pacing in people with Transcatheter Aortic Valve Implantation and Physiological Pacing, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Implantation, Physiological Pacing, Right Ventricular Pacing
- What is being tested?
- Conduction system pacing and Right ventricular pacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 30 Nov 2023to 15 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Successful implantation of TAVI according to VARC-3 criteria.
- Indication of cardiac pacing due to AV block according to ESC Guidelines.
- LVEF> 50%.
- The patient must indicate their acceptance to participate in the study by signing an informed consent document.
Who cannot join
- Ventricular dysfunction: LVEF <50%.
- Transapical TAVI.
- Participating currently in a clinical investigation that includes an active treatment.
- Patients with left bundle branch block but without indication of pacing (AV block).
- Life expectancy <12 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Lluís Mont, MD, PhD
About this study
Official title: Ranodmized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI (PHYSTAVI II)
Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint.
Read the detailed description
There is currently no evidence of the best mode of definitive pacing after TAVI in patients with preserved systolic ventricular function and AV block. Through this study, investigators intend to elucidate the best post TAVI pacing strategy, comparing the effect of right apical pacing vs. physiological pacing on the evolution of both echocardiographic and clinical parameters.
Investigators will include 24 patients without ventricular dysfunction (LVEF> 50%) and with AV block pacing indication after TAVI.
Patients will be randomized to 2 types of pacing (parallel randomized trial): physiological or right ventricular pacing (conventional).
PHYS-TAVI trial will analyze the following parameters in the 2 groups: survival; NYHA class; distance in the 6-minute walking test; hospital admissions; left ventricular function; echocardiographic asynchrony (strain and flash septal); NTproBNP; and quality of life/symptoms with the Kansas City Cardiomyopathy Questionnaire test (KCCQ-12)
Clinical, and echocardiographic follow-up will be performed for 1 year.
Inclusion of 24 more patients to those already included in the context of PHYSTAVI I (NCT04482816). Exploratory trial.
- Conditions
- Transcatheter Aortic Valve Implantation, Physiological Pacing, Right Ventricular Pacing, AV Block, Preserved Left Ventricular Systolic Function
- Being tested
- Conduction system pacing, Right ventricular pacing
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conduction system pacingProcedure or surgery
Left bundle branch pacing or His bundle branch pacing
Right ventricular pacingProcedure or surgery
Conventional pacing
| Study group | Role | What they receive |
|---|---|---|
| Conduction system pacing | Experimental | Lead placed in the His-Purkinje system (His or left bundle branch) in order to achieve QRS shortening and physiologic pacing.
Crossover from physiological pacing to right ventricular pacing will be allowed in case of failed His bundle pacing or left bundle branch pacing. Receives: Procedure: Conduction system pacing |
| Right ventricular pacing | Active comparator | Lead placed in the right ventricle (conventional pacing). Receives: Procedure: Right ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.
Determine the percentage of patients who improve at 12 months on a clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.
Measured: 12 months
Secondary outcomes (10)
Change in left ventricular ejection fraction.
Left ventricular ejection fraction (LVEF %) measured with Simpson method with echocardiography (Delta left ventricular ejection fraction: 12 months LVEF - baseline LVEF).
Measured: 12 months.
Correction of echocardiographic asynchrony: septal flash expressed in mm.
Correction of septal flash determined with echocardiography (M mode).
Measured: 30 days; 12 months.
Distance covered in the 6-minute walking test.
Distance in meters walked in 6 minutes.
Measured: 30 days; 12 months.
Change in NYHA (New York Heart Association) functional class.
NYHA functional class I, II, III, IV.
Measured: 30 days; 12 months.
Change in degree of mitral regurgitation.
Mitral regurgitation (MR) measured with echocardiography. The severity of MR graded as absent (0), mild (1), moderate (2), moderate-severe (3), or severe (4).
Measured: 30 days; 12 months.
Change in NTproBNP.
NTproBNP blood levels.
Measured: Baseline; 12 months.
Hospitalization due to heart failure.
Hospitalization: patient hospitalization (yes/no).
Measured: 12 months.
QRS duration.
QRS duration (milliseconds) measured with a 12-lead ECG (200mm/s).
Measured: Baseline
Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire).
Score in Kansas City Cardiomyopathy Questionnaire-12: (higher=better).
Measured: 30 days; 12 months.
Correction of global longitudinal strain
Global longitudinal strain assessed with two-dimensional speckle-tracking echocardiography
Measured: 30 days; 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start30 Nov 2023
- Primary completion15 Dec 2025
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ImplantationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
- Investigators
- Lluís Mont, MD, PhD, Study director, Hospital Clínic de Barcelona. IDIBAPS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197503
- Sponsor's protocol ID
- PHYSTAVI II
- Acronym
- PHYSTAVIII
- Status last verified
- Mar 2026
- First submitted
- 9 Dec 2023
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranodmized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI (PHYSTAVI II)
- ClinicalTrials.gov ID
- NCT06197503
- Acronym / sponsor ID
- PHYSTAVIII / PHYSTAVI II
- Conditions
- Transcatheter Aortic Valve Implantation, Physiological Pacing, Right Ventricular Pacing, AV Block, Preserved Left Ventricular Systolic Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 9 Jan 2024 (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.
Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint.
Detailed description
There is currently no evidence of the best mode of definitive pacing after TAVI in patients with preserved systolic ventricular function and AV block. Through this study, investigators intend to elucidate the best post TAVI pacing strategy, comparing the effect of right apical pacing vs. physiological pacing on the evolution of both echocardiographic and clinical parameters.
Investigators will include 24 patients without ventricular dysfunction (LVEF> 50%) and with AV block pacing indication after TAVI.
Patients will be randomized to 2 types of pacing (parallel randomized trial): physiological or right ventricular pacing (conventional).
PHYS-TAVI trial will analyze the following parameters in the 2 groups: survival; NYHA class; distance in the 6-minute walking test; hospital admissions; left ventricular function; echocardiographic asynchrony (strain and flash septal); NTproBNP; and quality of life/symptoms with the Kansas City Cardiomyopathy Questionnaire test (KCCQ-12)
Clinical, and echocardiographic follow-up will be performed for 1 year.
Inclusion of 24 more patients to those already included in the context of PHYSTAVI I (NCT04482816). Exploratory trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conduction system pacing | Experimental | Procedure: Conduction system pacingLead placed in the His-Purkinje system (His or left bundle branch) in order to achieve QRS shortening and physiologic pacing. Crossover from physiological pacing to right ventricular pacing will be allowed in case of failed His bundle pacing or left bundle branch pacing. |
| Right ventricular pacing | Active comparator | Procedure: Right ventricular pacingLead placed in the right ventricle (conventional pacing). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Successful implantation of TAVI according to VARC-3 criteria.
- Indication of cardiac pacing due to AV block according to ESC Guidelines.
- LVEF> 50%.
- The patient must indicate their acceptance to participate in the study by signing an informed consent document.
Key exclusion criteria (5 listed)
- Ventricular dysfunction: LVEF <50%.
- Transapical TAVI.
- Participating currently in a clinical investigation that includes an active treatment.
- Patients with left bundle branch block but without indication of pacing (AV block).
- Life expectancy <12 months.
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 |
|---|---|---|
| Conduction system pacingLeft bundle branch pacing or His bundle branch pacing | Procedure or surgery | Conduction system pacing |
| Right ventricular pacingConventional pacing | Procedure or surgery | Right ventricular pacing |
Primary outcome
Clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.
Time frame: 12 months
Determine the percentage of patients who improve at 12 months on a clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.
10 secondary outcomes
Change in left ventricular ejection fraction.
Time frame: 12 months.
Correction of echocardiographic asynchrony: septal flash expressed in mm.
Time frame: 30 days; 12 months.
Distance covered in the 6-minute walking test.
Time frame: 30 days; 12 months.
Change in NYHA (New York Heart Association) functional class.
Time frame: 30 days; 12 months.
Change in degree of mitral regurgitation.
Time frame: 30 days; 12 months.
Change in NTproBNP.
Time frame: Baseline; 12 months.
Hospitalization due to heart failure.
Time frame: 12 months.
QRS duration.
Time frame: Baseline
Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire).
Time frame: 30 days; 12 months.
Correction of global longitudinal strain
Time frame: 30 days; 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 31 Mar 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.
Lluís Mont, MD, PhD study director
Hospital Clínic de Barcelona. IDIBAPS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conduction system pacing and Right ventricular pacing in people with Transcatheter Aortic Valve Implantation and Physiological 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 4 inclusion and 5 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 31 Mar 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?
Contact Lluís Mont, MD, PhD (93 2271778 Ext. 2094, lmont@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test. (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 31 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.