Video-Assisted Left Atrial Appendage Exclusion Trial

Heart Diseases Clinical Trial

— VALET  

Official title:

A Clinical Trial to Evaluate Safety and Effectiveness of the LAAx,Inc., TigerPaw System II LAA Exclusion Device for the Exclusion of the Left Atrial Appendage Via Video-Assisted Thoracoscopic Surgery ("VATS")

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02226133
• Other study ID #: D&D CIP-0030
• Status: Withdrawn
• Phase: N/A
• First received: August 23, 2014
• Last updated: May 1, 2015
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: LAAx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Exclusion of the LAA(Left Atrial Appendage) using the TigerPaw II System with VATS technique is safe and effective.

Description:

The objective of this confirmatory study is to demonstrate that the LAAx, Inc. TigerPaw® II System can be safely and effectively used to exclude the Left Atrial Appendage (LAA) during cardiac surgery utilizing thoracoscopic camera and light source and thus remove, from the cleared indication for use, the direct vision limitation.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Greater than or equal to 18 years of age;

2. Capable and willing to give informed consent;

3. Able and willing to complete a 30 day ± 7 day follow-up evaluation;

4. Ejection fraction = 30%;

5. Life expectancy of > 1 year;

6. Stroke Risk (CHADS score of = 1), CHADS scoring: CHF=1 point, Hypertension (or treated hypertension) = 1 point, Age > 75 = 1 point, Diabetes = 1 point, Prior stroke or TIA = 2 points;

7. Subjects suitable for elective Video-Assisted Thoracoscopic Surgical (VATS) procedure(s) including, but not limited to, cardiac surgery for one or more of the following:

1. mitral valve repair or replacement,

2. aortic valve repair or replacement,

3. tricuspid valve repair or replacement,

4. coronary artery bypass procedures,

5. concomitant surgical (ablation or cut and sew) Maze procedure and other ablation procedures

6. hybrid procedures including combination surgical and interventional procedures and surgical procedures with a combination of left and right thoracic access sites

Exclusion Criteria:

1. Previous cardiac surgery;

2. Active systemic or cutaneous infection or inflammation;

3. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids not including intermittent use of inhaled steroids for respiratory diseases;

4. Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline INR =1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);

5. Severe co-existing morbidities having a life expectancy of less than 1 year;

6. Currently involved in any other investigational clinical trials that have not completed their primary endpoint or that may interfere with the TigerPaw study results;

7. Thrombus in the LAA/LA;

8. NYHA Class IV heart failure symptoms;

9. 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;

10. Preoperative need for an intra-aortic balloon pump;

11. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;

12. Females who are pregnant, planning to become pregnant within 1 month of the procedure, or lactating;

13. Extreme morbid obesity (BMI greater than 45 kg/m2);

14. Any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk;

15. Contraindication to Transesophageal Echocardiography (TEE);

16. Need for emergent cardiac surgery (e.g., cardiogenic shock);

17. Creatinine >200 umol/L;

18. Renal failure requiring dialysis or hepatic failure;

19. A known drug and/or alcohol addiction;

20. Concurrent chemotherapy.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Device:
• LAAx, Inc. TigerPaw® System II
Exclusion of Left Atrial Appendage.

Locations

Country	Name	City	State
United States	UMD School of Medicine	Baltimore	Maryland
United States	Geisinger Heart Institute	Danville	Pennsylvania
United States	ValleyCare Health System-Pleasanton	Pleasanton	California
United States	Lankenau MOB East	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
LAAx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of device related adverse and serious adverse events		30 (plus or minus 7) days	Yes
Secondary	Exclusion of the Left Atrial Appendage	Primary effectiveness will be measured by the percentage of patients with exclusion of the LAA assessed intraoperatively via endoscopic image and transesophageal echocardiography (TEE).	30 days	No