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

H

Hospital Clinic of Barcelona

Status

Enrolling

Conditions

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

Treatments

Procedure: Conduction system pacing
Procedure: Right ventricular pacing

Study type

Interventional

Funder types

Other

Identifiers

NCT06197503
PHYSTAVI II

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 2 patient groups

Conduction system pacing
Experimental group
Description:
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.
Treatment:
Procedure: Conduction system pacing
Right ventricular pacing
Active Comparator group
Description:
Lead placed in the right ventricle (conventional pacing).
Treatment:
Procedure: Right ventricular pacing

Trial contacts and locations

1

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Central trial contact

Lluís Mont, MD, PhD

Data sourced from clinicaltrials.gov

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