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Impact of Beta Blockers on TAVI (BETA-TAVI)

NCT05721170 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2024-12-09

No results posted yet for this study

Summary

This is a prospective, multicentre, investigator-initiated, randomized clinical trial clinical trial investigating the impact of beta-blockers administration among patients undergoing TAVI for severe aortic valve stenosis. Adults already receiving beta-blockers be assigned randomly in 1:1 ratio to either continue or withdraw the beta-blockers medication at least 72 hours before and at least 7 days after TAVI. The primary endpoint is permanent pacemaker implantation rates in 7 days after the procedure. Secondary endpoints include death, cardiogenic shock and arrhythmias/conduction abmormalities with time frame 12 months.

Conditions

  • Aortic Valve Stenosis

Interventions

DRUG

Beta blocker

Investigation on beta-blockers in TAVI and brief post-TAVI period.

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    lead OTHER

Principal Investigators

  • Leonidas Koliastasis, MD, MSc · National and Kapodistrian University of Athens

  • Odysseas Katsaros, MD · National and Kapodistrian University of Athens

  • Konstantinos Toutouzas, Professor · National and Kapodistrian University of Athens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2028-01-30
Completion
2028-01-31

Countries

  • Cyprus
  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05721170 on ClinicalTrials.gov