Video-Assisted Left Atrial Appendage Exclusion Trial

NCT02226133 | Withdrawn DMC

• 1 other identifier: D&D CIP-0030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Heart Diseases

Outcome Measures

Primary Outcomes (1)

• rate of device related adverse and serious adverse events

  30 (plus or minus 7) days

Secondary Outcomes (1)

• Exclusion of the Left Atrial Appendage

  30 days

Study Arms (1)

Exclusion of Left Atrial Appendage

EXPERIMENTAL

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

Interventions

LAAx, Inc. TigerPaw® System II DEVICE

Exclusion of Left Atrial Appendage.

Also known as: LAAx,Inc. TigerPaw System

Exclusion of Left Atrial Appendage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than or equal to 18 years of age;
• Capable and willing to give informed consent;
• Able and willing to complete a 30 day ± 7 day follow-up evaluation;
• Ejection fraction ≥ 30%;
• Life expectancy of \> 1 year;
• 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;
• 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:
• 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 and other ablation procedures
• hybrid procedures including combination surgical and interventional procedures and surgical procedures with a combination of left and right thoracic access sites

You may not qualify if:

• Previous cardiac surgery;
• Active systemic or cutaneous infection or inflammation;
• Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids not including intermittent use of inhaled steroids for respiratory diseases;
• 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);
• Severe co-existing morbidities having a life expectancy of less than 1 year;
• Currently involved in any other investigational clinical trials that have not completed their primary endpoint or that may interfere with the TigerPaw study results;
• Thrombus in the LAA/LA;
• NYHA Class IV heart failure symptoms;
• 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;
• Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
• Females who are pregnant, planning to become pregnant within 1 month of the procedure, or lactating;
• Extreme morbid obesity (BMI greater than 45 kg/m2);
• Any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk;
• Contraindication to Transesophageal Echocardiography (TEE);

Sponsors & Collaborators

• LAAx, Inc.: lead

Study Sites (4)

ValleyCare Health System-Pleasanton

Pleasanton, California, 94588, United States

Location

UMD School of Medicine

Baltimore, Maryland, 21201, United States

Location

Geisinger Heart Institute

Danville, Pennsylvania, 18711, United States

Location

Lankenau MOB East

Wynnewood, Pennsylvania, 19096, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2014
• First Posted: August 27, 2014
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

US (4)