Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI

Not Applicable

Recruiting

• Conditions: Transcatheter Aortic Valve Implantation; Physiological Pacing; AV Block; Preserved Left Ventricular Systolic Function; Right Ventricular Pacing

• Registration Number: NCT06197503
• Lead Sponsor: Hospital Clinic of Barcelona

Brief 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.

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 Timeline

• Study Start: 2023-11-30
• Study First Submitted: 2023-12-09
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.	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.

Secondary Outcome Measures

Name	Time	Method
Correction of echocardiographic asynchrony: septal flash expressed in mm.	30 days; 12 months.	Correction of septal flash determined with echocardiography (M mode).
Distance covered in the 6-minute walking test.	30 days; 12 months.	Distance in meters walked in 6 minutes.
Change in NYHA (New York Heart Association) functional class.	30 days; 12 months.	NYHA functional class I, II, III, IV.
Hospitalization due to heart failure.	12 months.	Hospitalization: patient hospitalization (yes/no).
QRS duration.	Baseline	QRS duration (milliseconds) measured with a 12-lead ECG (200mm/s).
Change in left ventricular ejection fraction.	12 months.	Left ventricular ejection fraction (LVEF %) measured with Simpson method with echocardiography (Delta left ventricular ejection fraction: 12 months LVEF - baseline LVEF).
Change in degree of mitral regurgitation.	30 days; 12 months.	Mitral regurgitation (MR) measured with echocardiography. The severity of MR graded as absent (0), mild (1), moderate (2), moderate-severe (3), or severe (4).
Change in NTproBNP.	Baseline; 12 months.	NTproBNP blood levels.
Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire).	30 days; 12 months.	Score in Kansas City Cardiomyopathy Questionnaire-12: (higher=better).
Correction of global longitudinal strain	30 days; 12 months	Global longitudinal strain assessed with two-dimensional speckle-tracking echocardiography

Trial Locations

Locations (1)

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain