Recruiting

Percutaneous Closure

Sponsor:

Texas Cardiac Arrhythmia Research Foundation

Code:

NCT03503253

Conditions

Left Atrial Appendage Incomplete Closure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Interlock-35 Fibered IDC Occlusion System

Concerto Helix Detachable Coil System

Azur Peripheral Coil System

Study Details

Brief summary:

Although the clinical impact of left atrial appendage (LAA) leaks still requires confirmation, the open pouch with residual flow resulting from incomplete LAA closure may promote blood stagnation and thrombus formation, and increase the risk of thromboembolic events. The main purpose of this trial is to evaluate the safety and efficacy of percutaneous leak closure with detachable vascular coils.

Conditions

Left Atrial Appendage Incomplete Closure

Study ID

NCT03503253

Start date

Apr 9, 2018

Status verified date

Apr, 2021

Completion date

May, 2022

Anticipated

Primary completion date

May, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age> 18 years.
  • Presence of a significant LAA leak (moderate/severe following percutaneous occlusions or mild/severe after epicardial exclusions with the LARIAT suture delivery device).
  • Less moderate embolic risk (CHA2DS2-VASc ≥2)
  • High associated hemorrhagic risk (HASBLED ≥ 3), or absolute contraindication to OAC, or need for prolonged dual antiplatelet therapy, or history of thromboembolic events despite LAA occlusion/exclusion after other potential causes.
  • written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion Criteria:

  • Life expectancy < 2 years.
  • pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
  • presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Single-arm

LAA leak closure using detachable coils; Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System

Interventions

Interlock-35 Fibered IDC Occlusion System

Use of detachable coil for LAA leak closure

Concerto Helix Detachable Coil System

Use of detachable coil for LAA leak closure

Azur Peripheral Coil System

Use of detachable coil for LAA leak closure

Primary outcome measure

  • Procedural success [ Time Frame: 7 days ]
  • Rate of LAA leak closure [ Time Frame: 60 days ]
  • Incidence of Major Adverse Events (MAE) [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Andrea Natale

5127842651andrea.natale@stdavids.com

Domenico G Della Rocca

512-544-8198domenico.dellarocca2@stdavids.com

Locations

Texas Cardiac Arrhythmia Institute

Recruiting

Austin, Texas, United States, 78705

Contacts

Andrea Natale

512-784-2651andrea.natale@stdavids.com

More Information

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Last update posted

Apr 6, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Cardiac Arrhythmia Research Foundation on 2021-04-06.