Heart and Vascular Care
The cardiologists and cardiovascular surgeons at Main Line Health work together to improve the detection and prevention of heart disease with the latest treatment options.
Clinical Trials
Clinical Trial Number: CLIP-IT
| Study ID: | CLIP-IT |
|---|---|
| Phase | N/A |
| Physician Investigator(s) | |
| Study Locations |
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Inclusion Criteria:
- Patient is indicated to be treated with the Penditure™ LAA Exclusion System
- Greater than or equal to 18 years of age
- The subject is willing and able to provide written informed consent and comply with study visit requirements
Exclusion Criteria:
- Prior LAA isolation attempt(s)
- Need for emergent cardiac surgery
- Subject is contraindicated for MDCT and/or TEE
- Life expectancy of less than 12 months
- History of cardiac surgery
- Pericarditis
- Presence of thrombus in the left atrium or LAA, prior to or during the procedure
- Patients requiring a heart transplant, insertion of a ventricular assist device or total artificial heart, and/or ascending aortic aneurysm or dissection repair requiring circulatory arrest
- NYHA Class IV heart failure symptoms
- Patient has a documented history of substance (drug or alcohol) abuse
- Known allergy to device components (Nickel and/or Titanium)
- In the opinion of the investigator, the subject is not a suitable candidate for LAA isolation due to risks outweighing potential benefits including, complexity of planned concomitant procedures, or other pre-existing medical conditions
- Currently participating in an investigational drug or another device trial or study (excluding registries)