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This study has been withdrawn prior to enrollment.
(This study has been withdrawn prior to enrollment)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
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Device: LARIAT Suture Delivery Device and Accessories
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Multicenter Registry of Permanent Ligation Approximation Closure Exclusion of the Left Atrial Appendage in Patients With Atrial Fibrillation III (PLACE III)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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).


Other Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: September 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LAA exclusion with LARIAT & Accessories
Permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680757

Locations
United States, Arizona
Banner Good Samaritan
Phoenix, Arizona, United States, 85006
United States, California
Scripps Green Hospital and Clinic
San Diego, California, United States, 92037
University of California, San Francisco
San Francisco, California, United States, 94122
United States, Florida
Baptist Hospital of Miami
Miami, Florida, United States, 33176
United States, Kansas
University of Kansas Hospital and Medical Center
Kansas City, Kansas, United States, 66160
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Texas
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Texas Heart Institute
Houston, Texas, United States, 77030
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Germany
Cardiovascular Center Frankfurt
Frankfurt, Germany, 60327
Poland
John Paul II Hospital
Krakow, Poland, 31202
Sponsors and Collaborators
University of California, San Francisco
SentreHEART, Inc.
Investigators
Principal Investigator: Gregory Marcus, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01680757     History of Changes
Other Study ID Numbers: RS-001 PLACE III
Study First Received: August 28, 2012
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Left Atrial Appendage
LARIAT
atrial fibrillation
contraindication to oral anticoagulation therapy

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014