Transcatheter Aortic Valve ImplantationPHYS-TAVINCT04482816
Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI
A study testing Physiological pacing and Right ventricular pacing in people with Transcatheter Aortic Valve Implantation and Physiological Pacing, run by Josep Lluis Mont Girbau 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?
- Physiological pacing and Right ventricular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 14 Sep 2020to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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-2 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.
About this study
Official title: Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI (PHYS-TAVI Trial)
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.
- Conditions
- Transcatheter Aortic Valve Implantation, Physiological Pacing, Right Ventricular Pacing, AV Block
- Being tested
- Physiological pacing, Right ventricular pacing
- Keywords
- TAVI, Physiological Pacing, AV Block
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological pacingDevice
Pacing of the his bundle or the left bundle branch
Right ventricular pacingDevice
Conventional pacing; right ventricular pacing
| Study group | Role | What they receive |
|---|---|---|
| Physiological pacing | Experimental | Lead placed in the His-Purkinje system (his or branch) in order to achieve QRS shortening and physiologic pacing. A backup lead will be implanted in the right ventricle.
If hisian pacing is not achieved (QRS is not shortened > 20% or QRS is not <130ms), the left bundle branch will be paced according to the criteria established in the literature (right branch block and intrinsic deflection <85ms).
Crossover from physiological pacing to right ventricular pacing will be allowed in the following situations: failed physiological pacing lead implantation; high thresholds (>3.5V / 1ms); no shortening of QRS (shortening <20%) or failure to meet non-selective HBP criteria or left bundle branch pacing criteria. Receives: Device: Physiological pacing |
| Right ventricular pacing | Active comparator | Lead placed in the right ventricle (conventional pacing). Receives: Device: 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 functional class.
NYHA functional class I, II, III, IV.
Measured: 30 days; 12 months
Change in degree of mitral regurgitation.
Mitral regurgitation measured with echocardiography.
Measured: 12 months
Change in NTproBNP.
NTproBNP blood levels.
Measured: 30 days; 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 (in the electrophysiology lab polygraph)
Measured: Implant; 12 months
Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire )
Score in KCCQ-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 posted23 Jul 2020
- Study start14 Sep 2020
- Primary completion30 Jun 2023
- Study completion30 Oct 2023
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 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josep Lluis Mont Girbau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
- Investigators
- José M Tolosana, MD, PhD, Principal investigator, Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.Margarida Pujol Lopez, MD, Principal investigator, Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.Lluís Mont, MD, PhD, Study director, Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.Eduard Guasch, MD, PhD, Study chair, Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482816
- Sponsor's protocol ID
- PHYS-TAVI TRIAL
- Acronym
- PHYS-TAVI
- Status last verified
- Dec 2023
- First submitted
- 14 Jul 2020
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pujol-Lopez M, Regueiro A, Graterol FR, Garcia-Ribas C, Uribe L, Jimenez-Arjona R, Borras R, Guasch E, Guichard JB, Carballeira L, Falzone PV, Regany-Closa M, Casal R, Poza M, Arbelo E, Porta-Sanchez A, Roca-Luque I, Sitges M, Doltra A, Tolosana JM, Mont L. Left Bundle Branch Versus Apical Pacing in Atrioventricular Block and Normal Cardiac Function Post-transcatheter Aortic Valve Implantation: PhysTAVI Trial. CJC Open. 2025 Jul 30;7(12):1610-1620. doi: 10.1016/j.cjco.2025.07.014. eCollection 2025 Dec.
PubMed 41542133
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI (PHYS-TAVI Trial)
- ClinicalTrials.gov ID
- NCT04482816
- Acronym / sponsor ID
- PHYS-TAVI / PHYS-TAVI TRIAL
- Conditions
- Transcatheter Aortic Valve Implantation, Physiological Pacing, Right Ventricular Pacing, AV Block
- Keywords
- TAVI, Physiological Pacing, AV Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Josep Lluis Mont GirbauUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 23 Jul 2020 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiological pacing | Experimental | Device: Physiological pacingLead placed in the His-Purkinje system (his or branch) in order to achieve QRS shortening and physiologic pacing. A backup lead will be implanted in the right ventricle. If hisian pacing is not achieved (QRS is not shortened > 20% or QRS is not <130ms), the left bundle branch will be paced according to the criteria established in the literature (right branch block and intrinsic deflection <85ms). Crossover from physiological pacing to right ventricular pacing will be allowed in the following situations: failed physiological pacing lead implantation; high thresholds (>3.5V / 1ms); no shortening of QRS (shortening <20%) or failure to meet non-selective HBP criteria or left bundle branch pacing criteria. |
| Right ventricular pacing | Active comparator | Device: 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-2 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 |
|---|---|---|
| Physiological pacingPacing of the his bundle or the left bundle branch | Device | Physiological pacing |
| Right ventricular pacingConventional pacing; right ventricular pacing | Device | 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 functional class.
Time frame: 30 days; 12 months
Change in degree of mitral regurgitation.
Time frame: 12 months
Change in NTproBNP.
Time frame: 30 days; 12 months
Hospitalization due to heart failure.
Time frame: 12 months
QRS duration
Time frame: Implant; 12 months
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 41542133Pujol-Lopez M, Regueiro A, Graterol FR, Garcia-Ribas C, Uribe L, Jimenez-Arjona R, Borras R, Guasch E, Guichard JB, Carballeira L, Falzone PV, Regany-Closa M, Casal R, Poza M, Arbelo E, Porta-Sanchez A, Roca-Luque I, Sitges M, Doltra A, Tolosana JM, Mont L. Left Bundle Branch Versus Apical Pacing in Atrioventricular Block and Normal Cardiac Function Post-transcatheter Aortic Valve Implantation: PhysTAVI Trial. CJC Open. 2025 Jul 30;7(12):1610-1620. doi: 10.1016/j.cjco.2025.07.014. eCollection 2025 Dec.
- 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.
José M Tolosana, MD, PhD principal investigator
Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
Margarida Pujol Lopez, MD principal investigator
Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
Lluís Mont, MD, PhD study director
Institut Clínic Cardiovascular (ICCV), Hospital Clínic 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 Physiological pacing and Right ventricular pacing in people with Transcatheter Aortic Valve Implantation and Physiological Pacing, run by Josep Lluis Mont Girbau 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: finished, as of the sponsor's last update on 15 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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?
On the ClinicalTrials.gov record for NCT04482816, 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 15 Dec 2023.