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

  • STATUS
    Recruiting
  • End date
    Sep 18, 2023
  • participants needed
    24
  • sponsor
    Josep Lluis Mont Girbau
Updated on 18 November 2021

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.

Details
Condition av block, block, av, transcatheter aortic valve implant, Physiological Pacing, Atrioventricular Block, TAVI, Transcatheter Aortic Valve Implantation, Right Ventricular Pacing, Transcatheter Aortic Valve Replacement
Treatment Right Ventricular Pacing, Physiological pacing, Physiological pacing
Clinical Study IdentifierNCT04482816
SponsorJosep Lluis Mont Girbau
Last Modified on18 November 2021

Eligibility

Yes No Not Sure

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
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