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

Atrial Fibrillation Clinical Trial

— PLACE III  

Official title:

Multicenter Registry of Permanent Ligation Approximation Closure Exclusion of the Left Atrial Appendage in Patients With Atrial Fibrillation III (PLACE III)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01680757
• Other study ID #: RS-001 PLACE III
• Status: Withdrawn
• Phase: Phase 4
• First received: August 28, 2012
• Last updated: February 21, 2013
• Start date: September 2012
• Est. completion date: March 2014

Study information

• Verified date: February 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• LARIAT Suture Delivery Device and Accessories

Locations

Country	Name	City	State
Germany	Cardiovascular Center Frankfurt	Frankfurt
Poland	John Paul II Hospital	Krakow
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	University of Kansas Hospital and Medical Center	Kansas City	Kansas
United States	Baptist Hospital of Miami	Miami	Florida
United States	Columbia University Medical Center	New York	New York
United States	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	Swedish Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	SentreHEART, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of procedural success	Exploratory objectives include assessment of the rate of procedural success (defined as completion of the procedure as intended at baseline, as assessed by the clinical site Principal Investigator)	Baseline	No
Other	Rate of complications	Exploratory objectives include assessment of the rate of complications related to the use of the LARIAT and accessories	During 1 year follow-up	Yes
Primary	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.	No