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

NCT ID: NCT04482816

Last Updated: 2023-12-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2023-10-30

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.

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.

Conditions

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Transcatheter Aortic Valve Implantation Physiological Pacing Right Ventricular Pacing AV Block

Keywords

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TAVI Physiological Pacing AV Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The patient will be explained to be randomized to either of the two branches. The type of therapy applied will not be communicated to the patient. The follow-up will be the same in the two branches. During the visits, it will not be said which therapy has been applied.

The echocardiographer and the follow-up by the Hemodynamic Team will be blind.

Study Groups

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Physiological pacing

Lead placed in the His-Purkinje system (his or branch) in order to achieve QRS shortening and physiologic pacing. A backup lead will be implanted in the right ventricle.

If hisian pacing is not achieved (QRS is not shortened \> 20% or QRS is not \<130ms), the left bundle branch will be paced according to the criteria established in the literature (right branch block and intrinsic deflection \<85ms).

Crossover from physiological pacing to right ventricular pacing will be allowed in the following situations: failed physiological pacing lead implantation; high thresholds (\>3.5V / 1ms); no shortening of QRS (shortening \<20%) or failure to meet non-selective HBP criteria or left bundle branch pacing criteria.

Group Type EXPERIMENTAL

Physiological pacing

Intervention Type DEVICE

Pacing of the his bundle or the left bundle branch

Right ventricular pacing

Lead placed in the right ventricle (conventional pacing).

Group Type ACTIVE_COMPARATOR

Right ventricular pacing

Intervention Type DEVICE

Conventional pacing; right ventricular pacing

Interventions

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Physiological pacing

Pacing of the his bundle or the left bundle branch

Intervention Type DEVICE

Right ventricular pacing

Conventional pacing; right ventricular pacing

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Josep Lluis Mont Girbau

OTHER

Sponsor Role lead

Responsible Party

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Josep Lluis Mont Girbau

Head of Arrhythmia Section. Professor of Cardiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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José M Tolosana, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.

Margarida Pujol Lopez, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.

Lluís Mont, MD, PhD

Role: STUDY_DIRECTOR

Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.

Eduard Guasch, MD, PhD

Role: STUDY_CHAIR

Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.

Locations

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Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PHYS-TAVI TRIAL

Identifier Type: -

Identifier Source: org_study_id