Clinical trial

Glucocorticoid Treatment in Patients Undergoing TAVR to Reduce the Incidence of Atrioventricular Block and Pacemaker Implantation

Name

2022-116

Description

The goal of this phase IV, randomized, controlled and open-label study is to assess the efficacy of peri-procedure glucocorticoid treatment in the prevention of conduction abnormalities and the need for pacemaker implantation in patients undergoing transaortic valve replacement compared to placebo. Participants randomized to the intervention group will receive a single dose of intravenous Methylprednisolone 7 mg/kg/day on the day of the procedure (1 hour before), followed by 15 mg/12 hours of daily Prednisone for 5 days. The primary endpoint is a composite of permanent pacemaker implantation and the occurrence of new conduction abnormalities (any-degree AV block, bundle branch block, or non-specific intraventricular conduction disorder) at discharge, at 30 days and 1 year.

Trial arms

Trial start

2023-08-12

Estimated PCD

2024-09-01

Trial end

2024-09-01

Status

Recruiting

Phase

Early phase I

Treatment

Methylprednisolone

The intervention group will recieve 7 mg/kg/day (or a maximum of 500 mg/day) of intravenous Methylprednisolone an hour before TAVR followed by 15 mg / 12h of Prednisone during 5 days after the intervention (starting 24h after the administration of Methylprednisolone).

Arms:

Intervention group (Glucocorticoid treatment)

Placebo

Saline solution

Arms:

Control group

Other names:

Saline solution

Size

100

Primary endpoint

Number of patients that requiere pacemaker implantation and/or who develop new conduction abnormalities (AV block, bundle branch block, and/or non-specific intraventricular conduction disorder).

One week, 30 days, and 1 year after admission

Eligibility criteria

Inclusion Criteria: * Patients eligible for TAVR implantation according to current European Society of Cardiology guidelines: patients with severe symptomatic aortic stenosis that are \> 75 years old or have a high surgical risk. Exclusion Criteria: * Patients with a prior pacemaker. * Patients with contraindications for the use of glucocorticoids including immunosuppression, active or latent infection, documented hypersensitivity or allergy, insulin-dependent diabetes mellitus, glaucoma (both closed-angle and open-angle), recent intestinal perforation, or acute heart failure. * Patients on prior chronic treatment with glucocorticoids (both oral, inhaled, or intravenous, but topical and ophthalmic administration is allowed). * Access for TAVR implantation other than femoral (for example, transapical). * Patients on medication that may interact with glucocorticoids.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase IV, single-center, randomized, controlled, and open label clinical trial (with blinded outcomes assessor).', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-10-11

1 organization

1 product

3 indications

Organization

Hospital General Universitario de Alicante

Product

Indication

Indication

Indication