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

Transcatheter Aortic Valve Implantation Clinical Trial

— PHYSTAVIII  

Official title:

Ranodmized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI (PHYSTAVI II)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06197503
• Other study ID #: PHYSTAVI II
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Hospital Clinic of Barcelona
• Contact: Lluís Mont, MD, PhD
• Phone: 93 2271778 Ext. 2094
• Email: lmont[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrioventricular Block
• AV Block
• Physiological Pacing
• Right Ventricular Pacing
• Transcatheter Aortic Valve Implantation

Intervention

Procedure:
• Conduction system pacing
Left bundle branch pacing or His bundle branch pacing
• Right ventricular pacing
Conventional pacing

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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).	12 months.
Secondary	Correction of echocardiographic asynchrony: septal flash expressed in mm.	Correction of septal flash determined with echocardiography (M mode).	30 days; 12 months.
Secondary	Distance covered in the 6-minute walking test.	Distance in meters walked in 6 minutes.	30 days; 12 months.
Secondary	Change in NYHA (New York Heart Association) functional class.	NYHA functional class I, II, III, IV.	30 days; 12 months.
Secondary	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).	30 days; 12 months.
Secondary	Change in NTproBNP.	NTproBNP blood levels.	Baseline; 12 months.
Secondary	Hospitalization due to heart failure.	Hospitalization: patient hospitalization (yes/no).	12 months.
Secondary	QRS duration.	QRS duration (milliseconds) measured with a 12-lead ECG (200mm/s).	Baseline
Secondary	Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire).	Score in Kansas City Cardiomyopathy Questionnaire-12: (higher=better).	30 days; 12 months.
Secondary	Correction of global longitudinal strain	Global longitudinal strain assessed with two-dimensional speckle-tracking echocardiography	30 days; 12 months