MedTrace Logo

The Role of Multimodality Imaging in Left Atrial Appendage Closure

NCT04800913 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-10-22

No results posted yet for this study

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 appendage closure procedures after unimodal and multimodal preprocedural imaging.

According to the investigators' primary hypothesis, simple, unimodal preprocedural imaging does not increase procedural burden of LAAC (total radiation dose, procedure time, fluoroscopy time, contrast amount). The investigators assume, that the success rate and safety of LAAC procedures is not reduced using unimodal preoperative imaging.

Regarding to postoperative imaging, the investigators aim to compare the sensitivity of different imaging techniques in detecting postoperative complications. We assume, that multimodal imaging technique increases the accuracy and sensitivity of the detection of postoperative complications (PDL, device thrombi).

Conditions

Interventions

DIAGNOSTIC_TEST

Multimodal imaging

Preoperative 2D/3D TOE and MDCT, operative 2D/3D TOE and fluoroscopy/angiography, postoperative 2D/3D TOE and MDCT

DIAGNOSTIC_TEST

Standard imaging

Preoperative MDCT, operative 2D/3D TOE and fluoroscopy/angiography, postoperative 2D/3D TOE and MDCT

Sponsors & Collaborators

  • Hungarian Institute of Cardiology

    lead OTHER_GOV

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2028-12-31
Completion
2029-12-01
FDA Device
Yes

Countries

  • Hungary

Study Locations

More Related Trials

Entities

Diseases

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 NCT04800913 on ClinicalTrials.gov