Video-Assisted Left Atrial Appendage Exclusion Trial
Withdrawn before enrolling · Not applicable
Conditions studied: Heart Diseases
In brief
Exclusion of the LAA(Left Atrial Appendage) using the TigerPaw II System with VATS technique is safe and effective.
Key facts
- Study ID
- NCT02226133
- Run by
- LAAx, Inc.
- People needed
- 0
- Starts
- 2015-04-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2015-05-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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);
- 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.
Where it is running
- ValleyCare Health System-Pleasanton — Pleasanton, California, United States
- UMD School of Medicine — Baltimore, Maryland, United States
- Geisinger Heart Institute — Danville, Pennsylvania, United States
- Lankenau MOB East — Wynnewood, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.