The Role of Multimodality Imaging in Left Atrial Appendage Closure

Atrial Fibrillation Clinical Trial

— MILAAC  

Official title:

The Role of Multimodality Imaging in Left Atrial Appendage Closure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04800913
• Other study ID #: MILAAC
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2021
• Est. completion date: January 1, 2027

Study information

• Verified date: April 2023
• Source: Hungarian Institute of Cardiology
• Contact: Peter Andreka, MD, PhD
• Phone: 0036703820470
• Email: peter.andreka[@]gokvi.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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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Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• Multimodal imaging
Preoperative 2D/3D TOE and MDCT, operative 2D/3D TOE and fluoroscopy/angiography, postoperative 2D/3D TOE and MDCT
• Standard imaging
Preoperative MDCT, operative 2D/3D TOE and fluoroscopy/angiography, postoperative 2D/3D TOE and MDCT

Locations

Country	Name	City	State
Hungary	Hungarian Institute of Cardiology (Gottsegen National Cardiovascular Center)	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Hungarian Institute of Cardiology

Country where clinical trial is conducted

Hungary, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective radiation dose	Total radiation dose of the patient resorbed during LAAC imaging and intervention (mSv)	Periprocedural (1 month) interval
Secondary	Fluoroscopy time	during LAAC procedure (min)	during the procedure
Secondary	Procedure time	of LAAC procedure (min)	during the procedure
Secondary	Contrast media amount	used during LAAC procedure (ml)	during the procedure
Secondary	Rate of successful implantations	left atrial appendage occluder successfully deployed and released	during the procedure
Secondary	Rate of patients with adequate seal of closure device	Adequate seal defined as no leak or residual leak< 5 mm established by postoperative TOE	6 weeks post-procedure
Secondary	Rate of procedural complications	Thromboembolic events, myocardial infarction, bleeding events, vascular complications, pericardial effusion, tamponade, infections, allergic reactions, renal insufficiency, device/air embolism, mortality	within 30 days post-procedure
Secondary	Rate of clinical events	Composite endpoint of thromboembolic events (ischemic stroke, TIA, systemic embolism)	2 years post-procedure