Heart DiseasesVALETNCT02226133
Video-Assisted Left Atrial Appendage Exclusion Trial
A study testing LAAx, Inc. TigerPaw® System II in people with Heart Diseases, run by LAAx, Inc. at 4 sites in United States.
Trial summary
Exclusion of the LAA(Left Atrial Appendage) using the TigerPaw II System with VATS technique is safe and effective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- LAAx, Inc. TigerPaw® System II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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);
- Need for emergent cardiac surgery (e.g., cardiogenic shock);
- Creatinine >200 umol/L;
- Renal failure requiring dialysis or hepatic failure;
- A known drug and/or alcohol addiction;
- Concurrent chemotherapy.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UMD School of Medicine
Baltimore, Maryland, 21201
Geisinger Heart Institute
Danville, Pennsylvania, 18711
ValleyCare Health System-Pleasanton
Pleasanton, California, 94588
Lankenau MOB East
Wynnewood, Pennsylvania, 19096
About this study
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")
Exclusion of the LAA(Left Atrial Appendage) using the TigerPaw II System with VATS technique is safe and effective.
Read the 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.
- Conditions
- Heart Diseases
- Being tested
- LAAx, Inc. TigerPaw® System II
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAAx, Inc. TigerPaw® System IIDevice
Also called LAAx,Inc. TigerPaw System
Exclusion of Left Atrial Appendage.
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: Device: LAAx, Inc. TigerPaw® System II |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of device related adverse and serious adverse events
Measured: 30 (plus or minus 7) days
Secondary outcomes (1)
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).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startApr 2015
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: stopped for operational reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- LAAx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226133
- Sponsor's protocol ID
- D&D CIP-0030
- Acronym
- VALET
- Status last verified
- May 2015
- First submitted
- 23 Aug 2014
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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")
- ClinicalTrials.gov ID
- NCT02226133
- Acronym / sponsor ID
- VALET / D&D CIP-0030
- Conditions
- Heart Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: stopped for operational reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- LAAx, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exclusion of the LAA(Left Atrial Appendage) using the TigerPaw II System with VATS technique is safe and effective.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exclusion of Left Atrial Appendage | Experimental | Device: LAAx, Inc. TigerPaw® System IILeft Atrial Appendage (LAA) occlusion, using the LAAx, Inc. TigerPaw® System II (delivery system and implant/Fastener) using VATS techniques, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAAx, Inc. TigerPaw® System IIAlso: LAAx,Inc. TigerPaw SystemExclusion of Left Atrial Appendage. | Device | Exclusion of Left Atrial Appendage |
Primary outcome
rate of device related adverse and serious adverse events
Time frame: 30 (plus or minus 7) days
1 secondary outcome
Exclusion of the Left Atrial Appendage
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAAx, Inc. TigerPaw® System II in people with Heart Diseases, run by LAAx, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of device related adverse and serious adverse events (time frame: 30 (plus or minus 7) days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.