Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04800913

The Role of Multimodality Imaging in Left Atrial Appendage Closure

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Hemorrhage Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hungarian Institute of Cardiology (Gottsegen National Cardiovascular Center)

Budapest, 1096, Hungary

Location status: Recruiting

Location contact

Anita Zadori, MD, PhD

CONTACT

[email protected]

0036303837011

About this study

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.

.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal imaging

Diagnostic Test

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

Standard imaging

Diagnostic Test

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

Primary outcomes

  1. Effective radiation dose

    Time frame: Periprocedural (1 month) interval

    Total radiation dose of the patient resorbed during LAAC imaging and intervention (mSv)

Secondary outcomes

  1. Fluoroscopy time

    Time frame: during the procedure

    during LAAC procedure (min)

  2. Procedure time

    Time frame: during the procedure

    of LAAC procedure (min)

  3. Contrast media amount

    Time frame: during the procedure

    used during LAAC procedure (ml)

  4. Rate of successful implantations

    Time frame: during the procedure

    left atrial appendage occluder successfully deployed and released

  5. Rate of patients with adequate seal of closure device

    Time frame: 6 weeks post-procedure

    Adequate seal defined as no leak or residual leak< 5 mm established by postoperative TOE

  6. Rate of procedural complications

    Time frame: 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

  7. Rate of clinical events

    Time frame: 2 years post-procedure

    Composite endpoint of thromboembolic events (ischemic stroke, TIA, systemic embolism)

Study contacts

Contact information is provided by the study sponsor or research team.

Geza Fontos, MD

CONTACT

[email protected]

0036703820358

Peter Andreka, MD, PhD

CONTACT

[email protected]

0036703820470

Sponsors and collaborators

Lead sponsor

Hungarian Institute of Cardiology

Other Gov

Registry information

Acronym: MILAAC

Important dates

Study start
2021
Primary completion
2028
Study completion
2029
First posted
Mar 16, 2021
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.