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Recruiting NCT04800913

The Role of Multimodality Imaging in Left Atrial Appendage Closure

No phase Interventional Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multimodal imaging, Standard imaging.
Who it may be relevant to
Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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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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

Primary outcome measures

  • Effective radiation dose [Time frame: Periprocedural (1 month) interval]
Secondary outcome measures (7)
  • Fluoroscopy time [Time frame: during the procedure]
  • Procedure time [Time frame: during the procedure]
  • Contrast media amount [Time frame: during the procedure]
  • Rate of successful implantations [Time frame: during the procedure]
  • Rate of patients with adequate seal of closure device [Time frame: 6 weeks post-procedure]
  • Rate of procedural complications [Time frame: within 30 days post-procedure]
  • Rate of clinical events [Time frame: 2 years post-procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Hungary · 1 center
  • Hungarian Institute of Cardiology (Gottsegen National Cardiovascular Center) — Budapest

Publications

  • 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. PMID 27567408
  • 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
  • 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 ant PMID 27979034
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT04800913 · MILAAC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗