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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Transcatheter Aortic Valve Implantation Physiological Pacing Right Ventricular Pacing AV Block Preserved Left Ventricular Systolic Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conduction system pacing

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.

Group Type EXPERIMENTAL

Conduction system pacing

Intervention Type PROCEDURE

Left bundle branch pacing or His bundle branch pacing

Right ventricular pacing

Lead placed in the right ventricle (conventional pacing).

Group Type ACTIVE_COMPARATOR

Right ventricular pacing

Intervention Type PROCEDURE

Conventional pacing

Interventions

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Conduction system pacing

Left bundle branch pacing or His bundle branch pacing

Intervention Type PROCEDURE

Right ventricular pacing

Conventional pacing

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No