Video-Assisted Left Atrial Appendage Exclusion Trial (VALET)

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")

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

Study Overview

• Status: Withdrawn
• Conditions: Heart Diseases
• Intervention / Treatment: Device: LAAx, Inc. TigerPaw® System II

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pleasanton, California, United States, 94588
      • ValleyCare Health System-Pleasanton
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • UMD School of Medicine
  • Pennsylvania
    • Danville, Pennsylvania, United States, 18711
      • Geisinger Heart Institute
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau MOB East

Participation Criteria

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. 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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exclusion of Left Atrial Appendage; Left Atrial Appendage (LAA) occlusion, using the LAAx, Inc. TigerPaw® System II (delivery system and implant/Fastener) using VATS techniques,	Device: LAAx, Inc. TigerPaw® System II; Exclusion of Left Atrial Appendage.; Other Names: LAAx,Inc. TigerPaw System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
rate of device related adverse and serious adverse events	30 (plus or minus 7) days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: LAAx, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 23, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 27, 2014

Study Record Updates

• Last Update Posted (Estimate): May 5, 2015
• Last Update Submitted That Met QC Criteria: May 1, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: D&D CIP-0030