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

Josep Lluis Mont Girbau24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Transcatheter Aortic Valve Implantation Physiological Pacing Right Ventricular Pacing AV Block

Interventions

Physiological pacingDEVICE

Pacing of the his bundle or the left bundle branch

Right ventricular pacingDEVICE

Conventional pacing; right ventricular pacing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Clinic de Barcelona

Barcelona, Spain

Outcomes

Primary Outcomes

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

Secondary Outcomes

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 functional class.

NYHA functional class I, II, III, IV.

Time frame: 30 days; 12 months

Change in degree of mitral regurgitation.

Mitral regurgitation measured with echocardiography.

Time frame: 12 months

Change in NTproBNP.

NTproBNP blood levels.

Time frame: 30 days; 12 months

Data from ClinicalTrials.gov

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