Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-03-31

Brief Summary

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This study is a prospective, multicenter, non-randomized trial of a stand-alone procedure for left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic events who are contraindicated for or intolerant of oral anticoagulation therapy. This study will enroll 100 participant, who will receive the LAA ligation study treatment. The objective of this registry is to assess the effectiveness of permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories in patients unable to be treated with standard anticoagulation therapy. The results of the study will be used to assess outcomes within the first year, post-treatment.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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LAA exclusion with LARIAT & Accessories

Permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories

Group Type EXPERIMENTAL

LARIAT Suture Delivery Device and Accessories

Intervention Type DEVICE

Interventions

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LARIAT Suture Delivery Device and Accessories

Intervention Type DEVICE

Other Intervention Names

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LARIATTM Suture Delivery Device ENDOCATH Occlusion Balloon SOFTIPTM Guide Cannula FINDRWIRZ Guide Wire System SURECUT Suture Cutter TENSURE Suture Puller

Eligibility Criteria

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Inclusion Criteria

1. Aged ≥ 21 years
2. Diagnosed non-valvular atrial fibrillation
3. Current CHADS2 score \> 2
4. Currently contraindicated to or intolerant of standard anticoagulation therapy (i.e., warfarin, dabigatran, apixaban, and rivaroxaban) due to at least one of the following: history of bleeding or high risk of bleeding; labile INR level (While on anticoagulation therapy, participant had INR results "out of therapeutic range" \> 40% of the time, over a minimum period of 2 months.); non-compliant, unwilling to take, or anticoagulant failure (e.g., TIA or stroke while on anticoagulant therapy).
5. Life expectancy of at least 1 year
6. Willing and able to return and comply with scheduled follow up visits
7. Willing and able to provide written informed consent

Exclusion Criteria

1. Prior cardiac surgery involving opening of pericardium (e.g., CABG, heart transplantation, valve surgery)
2. Prosthetic heart valve or ring in any position
3. Current NYHA Class IV heart failure symptoms
4. Current right heart failure
5. Myocardial infarction within last 3 months
6. Unstable angina within last 3 months
7. Current cardiogenic shock or hemodynamic instability
8. Current symptomatic carotid disease
9. Need for an intra-aortic balloon pump or intravenous inotropes
10. Embolic stroke within the last 30 days
11. Transient ischemic attack (TIA) within the last 30 days
12. Current diagnosis of active systemic infection
13. eGFR \< 60 mL/min/1.73m2 within last 3 months
14. Current renal failure requiring dialysis
15. ALT or AST level \> 3 times upper level of normal, indicating hepatic failure. (NOTE: normal range provided by local laboratory performing the measurement), based on most recent pre-procedure assessment (within 30 days of study treatment)
16. Current clinical evidence of cirrhosis
17. Any history of thoracic radiation
18. Current use of long term treatment with steroids, not including intermittent use of inhaled steroids for respiratory diseases
19. Diagnosed autoimmune disease known to be associated with pericarditis (i.e., specific connective tissue disorders)
20. Any history of pericarditis
21. Pectus excavatum (clinically defined by treating physician)
22. Severe scoliosis
23. Thrombocytopenia (platelet count \< 100 x 109/L) based on most recent pre-procedure assessment (within 30 days of study treatment)
24. Anemia with hemoglobin concentration of \< 10 g/dL based on most recent pre-procedure assessment (within 30 days of study treatment)
25. Pregnancy or desire to get pregnant within next 12 months.
26. Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this registry
27. Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study
28. Any other criteria, which would make the patient unsuitable to participate in this study as determined by clinical site Principal Investigator (e.g., an uncontrolled drug and/or alcohol addiction)

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No