NCT00962702

Brief Summary

The dual primary safety and effectiveness outcomes for the use of The TigerPaw System include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual cavity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2 stroke

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_2 stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

August 20, 2009

Status Verified

August 1, 2009

Enrollment Period

4 months

First QC Date

August 19, 2009

Last Update Submit

August 19, 2009

Conditions

Stroke

Keywords

ExclusionLeft Atrial AppendageSurgicalOpen chest

Outcome Measures

Primary Outcomes (1)

  • The dual primary safety and effectiveness outcomes include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual cavity.

    Patients will be evaluated at 30 days post surgery and at 90 days post surgery.

Secondary Outcomes (1)

  • The extent of complete exclusion of the LAA with minimal residual cavity.

    30 days post surgery and at 90 days post

Study Arms (1)

Exclusion of Left Atrial Appendage

EXPERIMENTAL

Exclusion of Left Atrial Appendage

Device: LAAx TigerPaw System

Interventions

LAAx TigerPaw SystemDEVICE

Exclusion of Left Atrial Appendage

Exclusion of Left Atrial Appendage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Greater than or equal to 18 years of age
  • Stroke Risk (CHADS score \> or = 2, CHADS scoring: CHF = 1 pt, Hypertension (or treated hypertension) = 1 pt, Age \> 75 = 1 pt, Diabetes = 1 pt, Prior stroke or TIA = 2 pts)
  • Subject scheduled to undergo elective non-endoscopic cardiac surgical procedure(s) including cardiac surgery for one or more of the following:
  • mitral valve repair or replacement
  • aortic valve repair or replacement
  • tricuspid valve repair or replacement
  • coronary artery bypass procedures
  • concomitant surgical (ablation or cut and sew) Maze procedure
  • Ejection fraction \> 30%
  • Absence of thrombus in LAA
  • During open procedure, LAA anatomy is determined to be suitable for closure
  • life expectancy of \> 1 year
  • patient willingness to cooperate with follow-up tests
  • Informed Consent

You may not qualify if:

  • Previous cardiac surgery
  • Contraindication to Transesophageal Echocardiography (TEE)
  • Thrombus in the LAA/LA
  • NYHA Class IV heart failure symptoms
  • Need for emergent cardiac surgery (e.g., cardiogenic shock)
  • Creatinine \> 200 umol/L
  • 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 the subject to understand the nature, significance and scope of the study and to cooperate with follow-up requirements
  • Preoperative need for an intra-aortic balloon pump or intravenous inotropes
  • Treatment with thoracic radiation
  • Concurrent chemotherapy
  • Long term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases
  • Known connective tissue disorders
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clarian Health / Methodist Hospital

Indianapolis, Indiana, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mark Slaughter, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael A Daniel, MS/ MBA

CONTACT

4154070223madaniel@clinregconsult.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 19, 2009

First Posted

August 20, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2009

Study Completion

October 1, 2010

Last Updated

August 20, 2009

Record last verified: 2009-08

Locations

US(1)