The Role of Multimodality Imaging in Left Atrial Appendage Closure

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Diagnostic Test: Multimodal imaging; Diagnostic Test: Standard imaging

• Registration Number: NCT04800913
• Lead Sponsor: Hungarian Institute of Cardiology

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 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).

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-term oral anticoagulant therapy, mainly due to previous major bleeding or high bleeding risk. As the majority of candidates are elderly patients with multiple morbidities, the reduction of procedural burden is of huge significance.

The aim of the present prospective, randomized, single-centre study is to examine the non-inferiority of unimodal (MDCT) vs. multimodal (MDCT+TOE) preprocedural imaging in percutaneous left atrial appendage closure. The investigators are going to assess the success rate, safety and complications of LAAC procedures, and determine the procedural burden (total radiation dose, procedure time, fluoroscopy time, contrast amount) of the interventions after preprocedural unimodal and multimodal appendage characterization and device sizing. Multimodal procedural guidance (2D/3D TOE, fluoroscopy-angiography) and multimodal postprocedural imaging (2D/3D TOE, MDCT) is going to be used to identify complications (peri-device leak, thrombus). The investigators are planning to compare the accuracy and additive value of different postoperative imaging techniques.

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Study Timeline

• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-14
• Study First Posted: 2021-03-16
• Study Start: 2021-11-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-19
• Last Update Posted: 2024-10-22
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal imaging	Multimodal imaging	Preoperative 2D/3D TOE AND MDCT for appendage characterisation and sizing Operative 2D/3D TOE and fluoroscopy/angiography for guiding and checking the procedural events and success Postoperative 2D/3D TOE and MDCT to assess the complications (peri-device leak, thrombus)
Standard imaging	Standard imaging	Preoperative MDCT for appendage characterisation and sizing Operative 2D/3D TOE and fluoroscopy/angiography for guiding and checking the procedural events and success Postoperative 2D/3D TOE and MDCT to assess the complications (peri-device leak, thrombus)

Primary Outcome Measures

Name	Time	Method
Effective radiation dose	Periprocedural (1 month) interval	Total radiation dose of the patient resorbed during LAAC imaging and intervention (mSv)

Secondary Outcome Measures

Name	Time	Method
Contrast media amount	during the procedure	used during LAAC procedure (ml)
Rate of successful implantations	during the procedure	left atrial appendage occluder successfully deployed and released
Procedure time	during the procedure	of LAAC procedure (min)
Rate of clinical events	2 years post-procedure	Composite endpoint of thromboembolic events (ischemic stroke, TIA, systemic embolism)
Rate of patients with adequate seal of closure device	6 weeks post-procedure	Adequate seal defined as no leak or residual leak\< 5 mm established by postoperative TOE
Rate of procedural complications	within 30 days post-procedure	Thromboembolic events, myocardial infarction, bleeding events, vascular complications, pericardial effusion, tamponade, infections, allergic reactions, renal insufficiency, device/air embolism, mortality
Fluoroscopy time	during the procedure	during LAAC procedure (min)

Trial Locations

Locations (1)

Hungarian Institute of Cardiology (Gottsegen National Cardiovascular Center); 🇭🇺 Budapest, Hungary