Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI

Transcatheter Aortic Valve Implantation Clinical Trial

— PHYS-TAVI  

Official title:

Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI (PHYS-TAVI Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04482816
• Other study ID #: PHYS-TAVI TRIAL
• Status: Completed
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: October 30, 2023

Study information

• Verified date: December 2023
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

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

Device:
• Physiological pacing
Pacing of the his bundle or the left bundle branch
• Right ventricular pacing
Conventional pacing; right ventricular pacing

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Josep Lluis Mont Girbau

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 functional class.	NYHA functional class I, II, III, IV.	30 days; 12 months
Secondary	Change in degree of mitral regurgitation.	Mitral regurgitation measured with echocardiography.	12 months
Secondary	Change in NTproBNP.	NTproBNP blood levels.	30 days; 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 (in the electrophysiology lab polygraph)	Implant; 12 months
Secondary	Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire )	Score in KCCQ-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