Left Atrial Appendage Exclusion Study | NCT01983605

Studies
Left Atrial Appendage Exclusion Study

NCT01983605

Sponsor

AtriCure, Inc.

Status

Completed

Last Update Posted

Jan 9, 2020Actual

Enrollment

96Actual

Phase

Not Applicable

Conditions

Atrial Appendage

Interventions

LARIAT Suture Delivery Device

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Mar 2011Actual

Completion Date

Dec 2013Actual

First Submitted Date

Nov 7, 2013

First Submission Date that Met QC Criteria

Nov 13, 2013

First Posted Date

Nov 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2020

Last Update Posted Date

Jan 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluate the safety and effectiveness of the LARIAT Suture Delivery device in excluding the left atrial appendage in 100 patients.

Detailed Description

The objective of this study is to evaluate the safety and effectiveness of the SentreHEART suture delivery system for the exclusion of the left atrial appendage in up to 100 treated patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	LAA exclusion with the LARIAT Suture Delivery Device	Device: LARIAT Suture Delivery Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LARIAT Suture Delivery Device	Device	LAA exclusion procedure	Treatment

Measure	Description	Time Frame
Rate of device related serious adverse events		30 days
Percent of patients with complete exclusion of the LAA measured with TEE		90 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is greater than or equal to 18 years of age
Subject has atrial fibrillation (paroxysmal or persistent)
Subject is poor candidate for Warfarin (contraindicated, labile INR, non-compliant)
Subject is willing and able to provide written informed consent
Subject has a life expectancy of at least 1 year
Subject is willing and able to return for scheduled follow up visits

Exclusion Criteria:

Previous cardiac surgery
Thrombus in the left atrial appendage or left atrium
NYHA Class IV heart failure symptoms
Need for emergent cardiac surgery (i.e. cardiogenic shock)
LAA is not appropriate for exclusion based upon intraoperative evaluations
Current diagnosis of active systemic infection
Renal failure requiring dialysis or hepatic failure
A known drug and/or alcohol addiction
Mental impairment or other conditions, which may not allow subject to understand the nature, significance and scope of the study
Pregnancy or desire to get pregnant within 12 months of the study treatment
Preoperative need for an intra-aortic balloon pump or intravenous inotropes
Patients who have been treated with thoracic radiation
Patients in current chemotherapy
Patients on long-term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases.
Patients with known connective tissue disorders, i.e. Lupus
Previous history of pericarditis
Presence of a PFO/ASD or valve implant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jerzy Sadowski, M.D., Ph.D	Jagiellonian University (John Paul II) Hospital	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23062528	Result	Bartus K, Han FT, Bednarek J, Myc J, Kapelak B, Sadowski J, Lelakowski J, Bartus S, Yakubov SJ, Lee RJ. Percutaneous left atrial appendage suture ligation using the LARIAT device in patients with atrial fibrillation: initial clinical experience. J Am Coll Cardiol. 2013 Jul 9;62(2):108-118. doi: 10.1016/j.jacc.2012.06.046. Epub 2012 Oct 10.