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

Withdrawn before enrolling · Phase 4

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01680757

Run by

University of California, San Francisco

People needed

0

Starts

2012-09-01

Expected to finish

2014-03-01

Last updated by the study team

2013-02-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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)
• Current clinical evidence of cirrhosis
• Any history of thoracic radiation
• Current use of long term treatment with steroids, not including intermittent use of inhaled steroids for respiratory diseases
• Diagnosed autoimmune disease known to be associated with pericarditis (i.e., specific connective tissue disorders)
• Any history of pericarditis
• Pectus excavatum (clinically defined by treating physician)
• Severe scoliosis
• Thrombocytopenia (platelet count < 100 x 109/L) based on most recent pre-procedure assessment (within 30 days of study treatment)
• Anemia with hemoglobin concentration of < 10 g/dL based on most recent pre-procedure assessment (within 30 days of study treatment)
• Pregnancy or desire to get pregnant within next 12 months.

Where it is running

• Banner Good Samaritan — Phoenix, Arizona, United States
• Scripps Green Hospital and Clinic — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• University of Kansas Hospital and Medical Center — Kansas City, Kansas, United States
• Columbia University Medical Center — New York, New York, United States
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States
• Texas Heart Institute — Houston, Texas, United States
• The Methodist Hospital Research Institute — Houston, Texas, United States
• Swedish Medical Center — Seattle, Washington, United States
• Cardiovascular Center Frankfurt — Frankfurt, Germany
• John Paul II Hospital — Krakow, Poland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.