Left Atrial Appendage Exclusion Study
PLACE II
1 other identifier
interventional
96
1 country
1
Brief Summary
Evaluate the safety and effectiveness of the LARIAT Suture Delivery device in excluding the left atrial appendage in 100 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 7, 2013
CompletedFirst Posted
Study publicly available on registry
November 14, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 9, 2020
October 1, 2016
1.2 years
November 7, 2013
January 6, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of device related serious adverse events
30 days
Percent of patients with complete exclusion of the LAA measured with TEE
90 days
Study Arms (1)
Treatment
EXPERIMENTALLAA exclusion with the LARIAT Suture Delivery Device
Interventions
Eligibility Criteria
You may qualify if:
- Subject is greater than or equal to 18 years of age
- Subject has atrial fibrillation (paroxysmal or persistent)
- Subject is poor candidate for Warfarin (contraindicated, labile INR, non-compliant)
- Subject is willing and able to provide written informed consent
- Subject has a life expectancy of at least 1 year
- Subject is willing and able to return for scheduled follow up visits
You may not qualify if:
- Previous cardiac surgery
- Thrombus in the left atrial appendage or left atrium
- NYHA Class IV heart failure symptoms
- Need for emergent cardiac surgery (i.e. cardiogenic shock)
- Current diagnosis of active systemic infection
- Renal failure requiring dialysis or hepatic failure
- A known drug and/or alcohol addiction
- Mental impairment or other conditions, which may not allow subject to understand the nature, significance and scope of the study
- Pregnancy or desire to get pregnant within 12 months of the study treatment
- Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- Patients who have been treated with thoracic radiation
- Patients in current chemotherapy
- Patients on long-term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases.
- Patients with known connective tissue disorders, i.e. Lupus
- Previous history of pericarditis
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AtriCure, Inc.lead
Study Sites (1)
Jagiellonian University (John Paul II) Hospital
Krakow, Poland
Related Publications (1)
Bartus K, Han FT, Bednarek J, Myc J, Kapelak B, Sadowski J, Lelakowski J, Bartus S, Yakubov SJ, Lee RJ. Percutaneous left atrial appendage suture ligation using the LARIAT device in patients with atrial fibrillation: initial clinical experience. J Am Coll Cardiol. 2013 Jul 9;62(2):108-118. doi: 10.1016/j.jacc.2012.06.046. Epub 2012 Oct 10.
PMID: 23062528RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Jerzy Sadowski, M.D., Ph.D
Jagiellonian University (John Paul II) Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2013
First Posted
November 14, 2013
Study Start
December 1, 2009
Primary Completion
March 1, 2011
Study Completion
December 1, 2013
Last Updated
January 9, 2020
Record last verified: 2016-10