Mitral Valve Insufficiency, Mitral Valve Prolapse, Mitral Valve Regurgitation
Conditions
Keywords
Mitral Valve Repair, Transapical, artificial chordae, bi-leaflet prolapse, anterior prolapse, posterior prolapse
Brief summary
The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide 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 ePTFE cordal length adjustment and 8) less complicated procedure that is teachable and adoptable.
Detailed description
The device is designed to reduce the degree of mitral regurgitation by delivering and anchoring artificial chordae tendineae to the affected mitral valve leaflet(s) in a beating heart.
Interventions
The Harpoon Medical Transapical device is intended to be used to reduce the degree of degenerative mitral regurgitation by delivering and anchoring one or more ePTFE cords to the affected mitral valve leaflet(s) via a small left thoracotomy on the beating heart in patients with anterior, bi-leaflet or posterior prolapse.
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Patient referred for mitral valve surgery * Presence of severe MR as read on an echocardiographic study performed within 60 days prior to procedure. * 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 associated with anterior, bileaflet, or posterior leaflet prolapse * Patient 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
Exclusion criteria
* Age \< 18 years * Infective endocarditis * History of Mediastinal Radiation * Inflammatory (rheumatic) valve disease * Requirement for concomitant cardiac surgery (e.g., coronary artery bypass grafting (CABG), aortic valve surgery, etc.) * Symptomatic coronary artery disease * Cardiogenic shock at the time of enrollment * ST segment elevation myocardial infarction requiring intervention within 30 days prior to enrollment * Evidence of cirrhosis or hepatic synthetic failure * Pregnancy at the time of enrollment (women of child bearing age should have negative pregnancy within 14 days of surgery) * Severe pulmonary hypertension (PA systolic pressure \> 70 mmHg) * Previous cardiac surgery, or surgery on the left pleural space * Left ventricular, atrial or appendage thrombus * Severely calcified mitral leaflets * Recent stroke (\< 6 months) with permanent impairment * EuroScore (for mitral valve repair) \> 8% * Patients 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Procedural Success During the First 30 Days | Procedure, discharge, and 30 days | To demonstrate that the Harpoon Medical Device performs as designed and can successfully implant one or more ePTFE artificial cords on either the anterior, posterior, or both leaflets of the mitral valve via a small left thoracotomy on the beating heart and reduce mitral regurgitation from severe to less than or equal to moderate at the conclusion of the procedure and at 30 days post-procedure. |
| Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days | Procedure, Discharge and 30 Days | Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Severity of Mitral Regurgitation Over Time | 6 Months, 12 Months, and 24 Months | Severity of mitral regurgitation at 6 months, 12 months and 24 months follow-up shall be tracked and recorded |
| Subject's Freedom From Serious Adverse Events Over Time | 6 Months, 12 Months, and 24 Months | Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Harpoon Medical Device Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Harpoon Medical Device | — |
|---|---|---|
| Age, Customized Age | 70 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 1 / 1 |
Outcome results
Primary
Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days
Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded.
Time frame: Procedure, Discharge and 30 Days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Harpoon Medical Device | Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days | Procedure | 0 Participants |
| Harpoon Medical Device | Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days | Discharge | 0 Participants |
| Harpoon Medical Device | Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days | 30 Days | 0 Participants |
Primary
Number of Subjects With Procedural Success During the First 30 Days
To demonstrate that the Harpoon Medical Device performs as designed and can successfully implant one or more ePTFE artificial cords on either the anterior, posterior, or both leaflets of the mitral valve via a small left thoracotomy on the beating heart and reduce mitral regurgitation from severe to less than or equal to moderate at the conclusion of the procedure and at 30 days post-procedure.
Time frame: Procedure, discharge, and 30 days
Population: Subject was not implanted with study Device
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Harpoon Medical Device | Number of Subjects With Procedural Success During the First 30 Days | Procedure | 0 Participants |
| Harpoon Medical Device | Number of Subjects With Procedural Success During the First 30 Days | Discharge | 0 Participants |
| Harpoon Medical Device | Number of Subjects With Procedural Success During the First 30 Days | 30 days follow-up | 0 Participants |
Secondary
Subject's Freedom From Serious Adverse Events Over Time
Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded
Time frame: 6 Months, 12 Months, and 24 Months
Population: Participant did not receive the Harpoon Medical Device.
Secondary
Subject's Severity of Mitral Regurgitation Over Time
Severity of mitral regurgitation at 6 months, 12 months and 24 months follow-up shall be tracked and recorded
Time frame: 6 Months, 12 Months, and 24 Months
Population: Participant did not receive the Harpoon Medical Device.