Status:

RECRUITING

The Role of Multimodality Imaging in Left Atrial Appendage Closure

Lead Sponsor:

Hungarian Institute of Cardiology

Conditions:

Atrial Fibrillation

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The aim of the present prospective, randomized single-centre study is to examine the success rate, safety, overall preoperative and operative burden and long-time outcome of percutaneous left atrial a...

Detailed Description

Left atrial appendage closure (LAAC) is an increasingly used non-pharmacologic strategy to prevent stroke in patients with atrial fibrillation who have absolute or relative contraindications to long-t...

Eligibility Criteria

Inclusion

  • Patients, who have clinical indication to LAAC and are undergoing percutaneous LAAC procedure in Gottsegen National Cardiovascular Center from 10.03.2021 to 31.12.2025
  • Age above 18 years
  • Informed consent
  • Legal capacity

Exclusion

  • Age under 18 years
  • Pregnancy
  • Incapacitation
  • Absence of consent
  • Esophageal stenosis or diverticulum
  • Active esophageal bleeding
  • CT-contrast agent allergy
  • Severe chronic kidney disease (GFR\<15 ml/min/1,73 m2)
  • Appendage thrombus (mobile/with significant embolic risk)
  • Life expectancy shorter than 12 months
  • Active infection
  • Significant mitral valve stenosis
  • Mechanical heart valve
  • Open heart surgery is indicated

Key Trial Info

Start Date :

November 8 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2029

Estimated Enrollment :

44 Patients enrolled

Trial Details

Trial ID

NCT04800913

Start Date

November 8 2021

End Date

December 1 2029

Last Update

October 22 2024

Active Locations (1)

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Hungarian Institute of Cardiology (Gottsegen National Cardiovascular Center)

Budapest, Hungary, 1096