Video-Assisted Left Atrial Appendage Exclusion Trial (VALET)

May 1, 2015 updated by: LAAx, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
rate of device related adverse and serious adverse events
Time Frame: 30 (plus or minus 7) days
30 (plus or minus 7) days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exclusion of the Left Atrial Appendage
Time Frame: 30 days
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LAAx, Inc.

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D&D CIP-0030

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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