The Role of Multimodality Imaging in Left Atrial Appendage Closure

NCT04800913 | Recruiting FDA Device

• 1 other identifier: MILAAC
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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).

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; ischemic stroke; left atrial appendage closure; bleeding

Outcome Measures

Primary Outcomes (1)

• Effective radiation dose

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

  Periprocedural (1 month) interval

Secondary Outcomes (7)

• Fluoroscopy time

  during the procedure

• Procedure time

  during the procedure

• Contrast media amount

  during the procedure

• Rate of successful implantations

  during the procedure

• Rate of patients with adequate seal of closure device

  6 weeks post-procedure

Study Arms (2)

Multimodal imaging

EXPERIMENTAL

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)

Diagnostic Test: Multimodal imaging

Standard imaging

EXPERIMENTAL

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)

Diagnostic Test: Standard imaging

Interventions

Multimodal imaging DIAGNOSTIC_TEST

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

Multimodal imaging

Standard imaging DIAGNOSTIC_TEST

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

Standard imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hungarian Institute of Cardiology: lead

Study Sites (1)

Hungarian Institute of Cardiology (Gottsegen National Cardiovascular Center)

Budapest, 1096, Hungary

RECRUITING

Related Publications (7)

• Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.

  PMID: 27567408 BACKGROUND

• Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4.

  PMID: 29103847 BACKGROUND

• Osmancik P, Tousek P, Herman D, Neuzil P, Hala P, Stasek J, Haman L, Kala P, Poloczek M, Branny M, Chovancik J, Cervinka P, Holy J, Vancura V, Rokyta R, Taborsky M, Kovarnik T, Zemanek D, Peichl P, Haskova S, Jarkovsky J, Widimsky P; PRAGUE-17 Investigators. Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study). Am Heart J. 2017 Jan;183:108-114. doi: 10.1016/j.ahj.2016.10.003. Epub 2016 Oct 11.

  PMID: 27979034 BACKGROUND

• Nucifora G, Faletra FF, Regoli F, Pasotti E, Pedrazzini G, Moccetti T, Auricchio A. Evaluation of the left atrial appendage with real-time 3-dimensional transesophageal echocardiography: implications for catheter-based left atrial appendage closure. Circ Cardiovasc Imaging. 2011 Sep;4(5):514-23. doi: 10.1161/CIRCIMAGING.111.963892. Epub 2011 Jul 7.

  PMID: 21737601 BACKGROUND

• Rajwani A, Nelson AJ, Shirazi MG, Disney PJS, Teo KSL, Wong DTL, Young GD, Worthley SG. CT sizing for left atrial appendage closure is associated with favourable outcomes for procedural safety. Eur Heart J Cardiovasc Imaging. 2017 Dec 1;18(12):1361-1368. doi: 10.1093/ehjci/jew212.

  PMID: 28013284 BACKGROUND

• Sievert H, Lesh MD, Trepels T, Omran H, Bartorelli A, Della Bella P, Nakai T, Reisman M, DiMario C, Block P, Kramer P, Fleschenberg D, Krumsdorf U, Scherer D. Percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high-risk patients with atrial fibrillation: early clinical experience. Circulation. 2002 Apr 23;105(16):1887-9. doi: 10.1161/01.cir.0000015698.54752.6d.

  PMID: 11997272 BACKGROUND

• Qamar SR, Jalal S, Nicolaou S, Tsang M, Gilhofer T, Saw J. Comparison of cardiac computed tomography angiography and transoesophageal echocardiography for device surveillance after left atrial appendage closure. EuroIntervention. 2019 Oct 20;15(8):663-670. doi: 10.4244/EIJ-D-18-01107.

  PMID: 31217149 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke; Hemorrhage

Interventions

Multimodal Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Anita Zadori, MD, PhD

  0036303837011, anita.zadori@gokvi.hu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Andreka, MD, PhD

CONTACT

0036703820470; peter.andreka@gokvi.hu

Geza Fontos, MD

CONTACT

0036703820358; geza.fontos@gokvi.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: cardiologist, Hungarian Institute of Cardiology (Gottsegen National Cardiovascular Center)

Model Details: Prospective randomized one-centre trial

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 16, 2021
• Study Start: November 8, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)