An interventional study of Conduction system pacing and Right ventricular pacing in Transcatheter Aortic Valve Implantation, Physiological Pacing and Right Ventricular Pacing, sponsored by Hospital Clinic of Barcelona. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Treatment
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.
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.
117 studies on the registry are indexed under Atrioventricular Block; 43 are open to participants now.
This study's planned enrollment of 48 is below the median of 127 across 78 interventional studies indexed under Atrioventricular Block.
Browse Atrioventricular Block studies →Hospital Clinic of Barcelona is the lead sponsor of 327 studies on the registry; 55 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Procedure: Conduction system pacing
Lead placed in the right ventricle (conventional pacing).
Procedure: Right ventricular pacing
Left bundle branch pacing or His bundle branch pacing
Conventional pacing
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.
Time frame: 12 months
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).
Time frame: 12 months.
Correction of echocardiographic asynchrony: septal flash expressed in mm.
Correction of septal flash determined with echocardiography (M mode).
Time frame: 30 days; 12 months.
Distance covered in the 6-minute walking test.
Distance in meters walked in 6 minutes.
Time frame: 30 days; 12 months.
Change in NYHA (New York Heart Association) functional class.
NYHA functional class I, II, III, IV.
Time frame: 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).
Time frame: 30 days; 12 months.
Change in NTproBNP.
NTproBNP blood levels.
Time frame: Baseline; 12 months.
Hospitalization due to heart failure.
Hospitalization: patient hospitalization (yes/no).
Time frame: 12 months.
QRS duration.
QRS duration (milliseconds) measured with a 12-lead ECG (200mm/s).
Time frame: Baseline
Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire).
Score in Kansas City Cardiomyopathy Questionnaire-12: (higher=better).
Time frame: 30 days; 12 months.
Correction of global longitudinal strain
Global longitudinal strain assessed with two-dimensional speckle-tracking echocardiography
Time frame: 30 days; 12 months
Plan to share: No
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