Left Atrial Appendage Exclusion Study (PLACE II)

January 6, 2020 updated by: AtriCure, Inc.

Left Atrial Appendage Exclusion Study II

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
LAA exclusion with the LARIAT Suture Delivery Device
Device: LARIAT Suture Delivery Device
LAA exclusion procedure

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AtriCure, Inc.

Investigators

  • Principal Investigator: Jerzy Sadowski, M.D., Ph.D, Jagiellonian University (John Paul II) Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 7, 2013

First Submitted That Met QC Criteria

November 13, 2013

First Posted (Estimate)

November 14, 2013

Study Record Updates

Last Update Posted (Actual)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • RS-001 V3.0_120709

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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