Multimodality Evaluation of LAA Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry

December 28, 2021 updated by: Kansas City Heart Rhythm Research Foundation

Comparison of the Efficacy of Successful Leak Closure Between Available Leak Closure Methods for Clinically Relevant and Persisting Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry

Closure of peri-device leaks (PDL) after incomplete LAAC have shown early feasibility, however no comparison study of all the leak closure modalities exists. Therefore, this is an attempt to report the first 3-way observational comparison study to date, with results in 160 total patients in 3 arms including detachable embolization coils, vascular plugs/septal occluders and Radiofrequency ablation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Left Atrial Appendage (LAA) Closure (LAAC) is a potent technique of LAA isolation and exclusion for stroke prevention in patients with atrial fibrillation, with evidence from the PROTECT-AF and PREVAIL-AF trials, including their 5-year follow-up assessments, solidifying LAAC as a viable option in these patients with comparable stroke reduction in comparison to oral anticoagulation (OAC) as well as a reduction in bleeding risk, hemorrhagic CVA, and mortality. However, the surge in the multiple methods of LAA exclusion has also brought to attention postprocedural complications specific to LAAC, namely, peri-device leaks (PDL). The stroke implication and classification of PDL itself still lacks consensus, with an increased thromboembolic (TE) potential due to PDL seen in patients with LARIAT and surgical ligation procedures, yet no statistically significant relationship seen in percutaneous and endocardial LAA closure approaches. PDL > 5mm has been widely accepted as clinically significant, although there remains limited data with no current established guidelines. Placement of a septal occluder device such as Amplatzer Vascular Plug, Detachable embolization coils, Gore Cardioform Septal Occluder (CSO; W.L. Gore and Associates, Newark DE), and radiofrequency ablation (RFA) have all emerged as options to resolve residual PDL and post-surgical/ligation leaks. However, there exists no head-to-head comparison between these modalities. Given their emergence, this is a proposed a multi-center observational study to further assess and evaluate these three treatment modalities for their efficacy for leak closure, assessment of pre-, peri- and post-procedural characteristics after leak closure, TE events, and bleeding risk, and complication rates.

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Kansas City Heart Rhythm Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients at risk for stroke or thromboembolism that demonstrated any degree of the significant leak on follow up TEE imaging at least 4-6 weeks following either epicardial, endocardial, or surgical LAAC were included in this study population. All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.

Description

Inclusion Criteria:

  1. Patients at risk for stroke or thromboembolism that demonstrated any degree of the significant leak on follow up TEE imaging at least 4-6 weeks following either epicardial, endocardial, or surgical LAAC
  2. Patients undergoing any form of eccentric or centric/central leak closure with available modalities (detachable embolization coils, vascular plus/septal/ASD occluders, or RF Ablation). Criteria for this was made based on the judgement of the operator, with no specific cutoffs for leak size, follow-up time from LAAC to leak closure, etc)
  3. Age greater than 18 years

Exclusion Criteria:

  1. Patients not undergoing leak closure after incomplete LAAC
  2. Patients unable to complete 45 day follow-up imaging for reevaluation of LAA leak
  3. Patients unable to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Detachable embolization coils group
Patients who have an intervention for leak closure with detachable embolization coils
Other: leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA
All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
Vascular plugs/septal occluders group
Patients who have an intervention for leak closure with vascular plugs/CSO
Other: leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA
All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
RF Ablation group
Patients who have an intervention for leak closure with Radio Frequency Ablation (RFA)
Other: leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA
All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of closure (in mm) of PDL/reduction in size of PDL after leak closure procedure
Time Frame: 1/11/2015 - 3/14/2021
Size of leak in mm on TEE after leak closure procedure, immediately at the end of the procedure and on 45 day follow-up TEE
1/11/2015 - 3/14/2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periprocedural complications occurring from Postoperative day #0 - day 7
Time Frame: 1/11/2015 - 6/8/2021
Primary Safety Endpoint: periprocedural complications occurring from Postoperative days 0 - 7, including: device-related thrombus, pericardial effusion/pericardial tamponade requiring intervention and CVA.
1/11/2015 - 6/8/2021
Delayed procedure-related complications and adverse events within 90 days of procedure
Time Frame: 1/11/2015 - 6/8/2021
Secondary Safety Endpoint: Delayed procedure-related complications and adverse events within 90 days of procedure including device-related thrombus, pericardial effusion/ pericardial tamponade requiring intervention and CVA.
1/11/2015 - 6/8/2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Heart Rhythm Research Foundation

Investigators

  • Principal Investigator: Dhanunjaya Lakkireddy, Kansas City Heart Rhythm Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2015

Primary Completion (Actual)

March 14, 2021

Study Completion (Actual)

June 8, 2021

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

November 10, 2021

First Posted (Actual)

November 23, 2021

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

December 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KCHRF-LAA Leak Registry-0007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share the data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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