N/A
Completed N=13
Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)
Mitral Valve Regurgitation · Mitral valve prolapse · Mitral Valve Insufficiency
Source: ClinicalTrials.gov NCT02771275 ↗
Enrolled (actual)
13
Serious AEs
46.2%
Results posted
Nov 2019
Primary outcomePrimary: Number of Subjects With Procedural Success During the First 30 Days — 12 Participants
Summary
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TEE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Procedural Success During the First 30 Days |
12 | — |
| PRIMARY Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days |
100.0; 84.6 | — |
| PRIMARY Subject's Serious Adverse Events (SAE) Through Discharge |
1 | — |
| SECONDARY Subject's Severity of Mitral Regurgitation Over Time |
1; 4; 4; 2; 1; 1 | — |
| SECONDARY Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days |
61.5; 53.8; 53.8; 53.8; 53.8; 53.8 | — |
Eligibility Criteria
Inclusion Criteria
- All subjects referred for mitral valve surgery
- Presence of severe mitral regurgitation as read on an echocardiographic study performed within 60 days prior to procedure. Assessment of mitral regurgitation will be performed by the investigational site echocardiography laboratory and confirmed by the Core Echocardiography Laboratory using an integrative method.
- Age > 18 years
- Estimated post-ePTFE cordal implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee
- Degenerative mitral valve disease
- Subject is able to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation
- Women of child-bearing potential have a negative pregnancy test
- Able to sign informed consent
Exclusion Criteria
- Age 70 mmHg)
- Previous cardiac surgery, or surgery on the left pleural space
- Left ventricular, atrial or appendage thrombus
- Severely calcified mitral leaflets
- Recent stroke ( 8%
- Subjects with contraindications to transesophageal echocardiography
- Severe left or right ventricular dysfunction
- NYHA Class IV
- Renal insufficiency CKD stage 3b or worse (GFR < 45 ml/min/1.73 m2)
- Patient is participating in another clinical study for which follow-up is currently ongoing. (Co-enrollment in an investigational device or interventional study)
- Patient with non-cardiac co-morbidities and life expectancy < 1 year
- Patient has a condition or conditions that, in the opinion of the Investigator, preclude participation, including willingness to comply with all follow-up procedures
Data sourced from ClinicalTrials.gov (NCT02771275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.