CClinicalTrials.gg
CompletedNCT01983605PLACE IIUpdated Jan 9, 2020

Left Atrial Appendage Exclusion Study

An interventional study of LARIAT Suture Delivery Device in Atrial Appendage, sponsored by AtriCure, Inc.. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-09.

Sponsored by AtriCure, Inc. · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Evaluate the safety and effectiveness of the LARIAT Suture Delivery device in excluding the left atrial appendage in 100 patients.

Read the detailed description

The objective of this study is to evaluate the safety and effectiveness of the SentreHEART suture delivery system for the exclusion of the left atrial appendage in up to 100 treated patients.

02

Conditions studied

  • Atrial Appendage
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In context

Lead sponsor

AtriCure, Inc. is the lead sponsor of 31 studies on the registry; 5 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject is greater than or equal to 18 years of age
  2. Subject has atrial fibrillation (paroxysmal or persistent)
  3. Subject is poor candidate for Warfarin (contraindicated, labile INR, non-compliant)
  4. Subject is willing and able to provide written informed consent
  5. Subject has a life expectancy of at least 1 year
  6. Subject is willing and able to return for scheduled follow up visits

Exclusion criteria

Exclusion Criteria:

  1. Previous cardiac surgery
  2. Thrombus in the left atrial appendage or left atrium
  3. NYHA Class IV heart failure symptoms
  4. Need for emergent cardiac surgery (i.e. cardiogenic shock)
  5. LAA is not appropriate for exclusion based upon intraoperative evaluations
  6. Current diagnosis of active systemic infection
  7. Renal failure requiring dialysis or hepatic failure
  8. A known drug and/or alcohol addiction
  9. Mental impairment or other conditions, which may not allow subject to understand the nature, significance and scope of the study
  10. Pregnancy or desire to get pregnant within 12 months of the study treatment
  11. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
  12. Patients who have been treated with thoracic radiation
  13. Patients in current chemotherapy
  14. Patients on long-term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases.
  15. Patients with known connective tissue disorders, i.e. Lupus
  16. Previous history of pericarditis
  17. Presence of a PFO/ASD or valve implant
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    Treatment

    LAA exclusion with the LARIAT Suture Delivery Device

    Device: LARIAT Suture Delivery Device

Interventions

  • DeviceLARIAT Suture Delivery Device

    LAA exclusion procedure

06

What researchers measure

Primary outcomes

  1. Rate of device related serious adverse events

    Time frame: 30 days

  2. Percent of patients with complete exclusion of the LAA measured with TEE

    Time frame: 90 days

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Study locations

1 site
  • Jagiellonian University (John Paul II) Hospital
    Krakow, Poland
08

References and documents

Publications

  • 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. PubMed 23062528 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01983605
Lead sponsor
AtriCure, Inc.
Responsible party
Sponsor
First posted
Nov 14, 2013
Start date
Dec 2009
Primary completion
Mar 2011
Completion
Dec 2013
Last update
Jan 9, 2020

Study contacts

Jerzy Sadowski, M.D., Ph.D
principal investigator · Jagiellonian University (John Paul II) Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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