Left Atrial Appendage Exclusion Study

Left Atrial Appendage Exclusion Study II

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01983605

Acronym

PLACE II

Enrollment

Registered

2013-11-14

Start date

2009-12-31

Completion date

2013-12-31

Last updated

2020-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Appendage

Brief summary

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

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.

Interventions

DEVICELARIAT Suture Delivery Device

LAA exclusion procedure

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame
Rate of device related serious adverse events	30 days
Percent of patients with complete exclusion of the LAA measured with TEE	90 days

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026