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

This study has been withdrawn prior to enrollment.
(This study has been withdrawn prior to enrollment)
Sponsor:
Collaborator:
SentreHEART, Inc.
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01680757
First received: August 28, 2012
Last updated: February 21, 2013
Last verified: February 2013

August 28, 2012
February 21, 2013
September 2012
March 2014   (final data collection date for primary outcome measure)
Rate of complete exclusion [ Time Frame: During 1 year follow-up. ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01680757 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • Rate of procedural success [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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)
  • Rate of complications [ Time Frame: During 1 year follow-up ] [ Designated as safety issue: Yes ]
    Exploratory objectives include assessment of the rate of complications related to the use of the LARIAT and accessories
Same as current
 
Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation - III
Multicenter Registry of Permanent Ligation Approximation Closure Exclusion of the Left Atrial Appendage in Patients With Atrial Fibrillation III (PLACE III)

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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Atrial Fibrillation
Device: LARIAT Suture Delivery Device and Accessories
Other Names:
  • LARIATTM Suture Delivery Device
  • ENDOCATH Occlusion Balloon
  • SOFTIPTM Guide Cannula
  • FINDRWIRZ Guide Wire System
  • SURECUT Suture Cutter
  • TENSURE Suture Puller
Experimental: LAA exclusion with LARIAT & Accessories
Permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories
Intervention: Device: LARIAT Suture Delivery Device and Accessories
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2014
March 2014   (final data collection date for primary outcome measure)

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)
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Poland
 
NCT01680757
RS-001 PLACE III
No
University of California, San Francisco
University of California, San Francisco
SentreHEART, Inc.
Principal Investigator: Gregory Marcus, MD University of California, San Francisco
University of California, San Francisco
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP