Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation - III

NCT01680757 | Withdrawn Phase 4

• 1 other identifier: RS-001 PLACE III
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 12

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Left Atrial Appendage; LARIAT; atrial fibrillation; contraindication to oral anticoagulation therapy

Outcome Measures

Primary Outcomes (1)

• Rate of complete exclusion

  To assess the rate of complete exclusion of the left atrial appendage (defined as \< 1 mm of communication between left appendage and atrium) measured by color duplex transesophageal echocardiography TEE).

  During 1 year follow-up.

Other Outcomes (2)

• Rate of procedural success

  Baseline

• Rate of complications

  During 1 year follow-up

Study Arms (1)

LAA exclusion with LARIAT & Accessories

EXPERIMENTAL

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

Device: LARIAT Suture Delivery Device and Accessories

Interventions

LARIAT Suture Delivery Device and Accessories DEVICE

Also known as: LARIATTM Suture Delivery Device, ENDOCATH Occlusion Balloon, SOFTIPTM Guide Cannula, FINDRWIRZ Guide Wire System, SURECUT Suture Cutter, TENSURE Suture Puller

LAA exclusion with LARIAT & Accessories

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 21 years
• Diagnosed non-valvular atrial fibrillation
• Current CHADS2 score \> 2
• 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).
• Life expectancy of at least 1 year
• Willing and able to return and comply with scheduled follow up visits
• Willing and able to provide written informed consent

You may not qualify if:

• Prior cardiac surgery involving opening of pericardium (e.g., CABG, heart transplantation, valve surgery)
• Prosthetic heart valve or ring in any position
• Current NYHA Class IV heart failure symptoms
• Current right heart failure
• Myocardial infarction within last 3 months
• Unstable angina within last 3 months
• Current cardiogenic shock or hemodynamic instability
• Current symptomatic carotid disease
• Need for an intra-aortic balloon pump or intravenous inotropes
• Embolic stroke within the last 30 days
• Transient ischemic attack (TIA) within the last 30 days
• Current diagnosis of active systemic infection
• eGFR \< 60 mL/min/1.73m2 within last 3 months
• Current renal failure requiring dialysis
• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• AtriCure, Inc.: collaborator

Study Sites (12)

Banner Good Samaritan

Phoenix, Arizona, 85006, United States

Location

Scripps Green Hospital and Clinic

San Diego, California, 92037, United States

Location

University of California, San Francisco

San Francisco, California, 94122, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

University of Kansas Hospital and Medical Center

Kansas City, Kansas, 66160, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Cardiovascular Center Frankfurt

Frankfurt, 60327, Germany

Location

John Paul II Hospital

Krakow, 31202, Poland

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory Marcus, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: September 7, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

DE (1); PL (1); US (10)