Mitral Valve Insufficiency, Mitral Valve Prolapse, Mitral Valve Regurgitation
Conditions
Keywords
Mitral Valve Repair, Transapical, Artificial Chordae
Brief summary
The purpose 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 TOE-guided chordal 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
It is anticipated that use of the Harpoon device could achieve similar outcomes to open cardiac surgery while decreasing the invasiveness of mitral valve repair.
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 chordae tendineae implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee * Degenerative mitral valve disease * 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 * Anterior or bileaflet prolapse * Functional MR * 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 Transoesophageal 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 |
|---|---|---|
| Subject's Procedural Success During the First 30 Days | End of procedure through 30 days | Procedural success was defined as the patient leaving the operating room with a successful implant of one or more ePTFE cords on the mitral valve and reduced mitral regurgitation from severe to \</=moderate at the conclusion of the procedure and at 30 days post-procedure. |
| Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days | Procedure and 30 days | Subject's freedom from Serious Adverse Events during the ePTFE implantation procedure and at 30 days follow-up. Time to events were estimated by Kaplan-Meier method. |
| Subject's Serious Adverse Events (SAE) Through Discharge | Discharge, an average of 5 days post implant | Number of Participants experiencing a Serious Adverse Event (SAE) through time of Discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Severity of Mitral Regurgitation Over Time | 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months | Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. The numbers on the scale are reflected as follows: 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome. |
| Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months | Subject's freedom from Serious Adverse Events at \>30 days post-implant. Time to events were estimated by Kaplan-Meier method. |
Countries
Italy, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Harpoon Medical Device Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Exit | 4 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Reoperation | 6 |
Baseline characteristics
| Characteristic | Harpoon Medical Device | — |
|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 11.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 26 |
| other Total, other adverse events | 17 / 26 |
| serious Total, serious adverse events | 19 / 26 |
Outcome results
Primary
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days
Subject's freedom from Serious Adverse Events during the ePTFE implantation procedure and at 30 days follow-up. Time to events were estimated by Kaplan-Meier method.
Time frame: Procedure and 30 days
Population: This outcome is reported for subjects who were enrolled in the trial where data is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Harpoon Medical Device | Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days | KM estimate: Procedure | 92.3 percentage of subjects |
| Harpoon Medical Device | Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days | KM estimate: 30 Days | 57.7 percentage of subjects |
Primary
Subject's Procedural Success During the First 30 Days
Procedural success was defined as the patient leaving the operating room with a successful implant of one or more ePTFE cords on the mitral valve and reduced mitral regurgitation from severe to \</=moderate at the conclusion of the procedure and at 30 days post-procedure.
Time frame: End of procedure through 30 days
Population: This outcome is reported for enrolled subjects where data is available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Harpoon Medical Device | Subject's Procedural Success During the First 30 Days | 23 Participants |
Primary
Subject's Serious Adverse Events (SAE) Through Discharge
Number of Participants experiencing a Serious Adverse Event (SAE) through time of Discharge.
Time frame: Discharge, an average of 5 days post implant
Population: This outcome is reported for enrolled subjects where data is available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Harpoon Medical Device | Subject's Serious Adverse Events (SAE) Through Discharge | 6 Participants |
Secondary
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
Subject's freedom from Serious Adverse Events at \>30 days post-implant. Time to events were estimated by Kaplan-Meier method.
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
Population: This outcome is reported for subjects who were enrolled in the trial where data is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Harpoon Medical Device | Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | KM estimate: 6 months | 46.2 percentage of subjects |
| Harpoon Medical Device | Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | KM estimate:12 months | 38.5 percentage of subjects |
| Harpoon Medical Device | Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | KM estimate:18 months | 38.5 percentage of subjects |
| Harpoon Medical Device | Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | KM estimate:24 months | 38.5 percentage of subjects |
| Harpoon Medical Device | Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | KM estimate:30 months | 38.5 percentage of subjects |
| Harpoon Medical Device | Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | KM estimate:36 months | 38.5 percentage of subjects |
Secondary
Subject's Severity of Mitral Regurgitation Over Time
Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. The numbers on the scale are reflected as follows: 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
Population: This outcome is reported for subjects who received the Harpoon Medical Device where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 24 month follow-up | Trace | 9 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 30 month follow-up | Severe | 4 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 6 month follow-up | None | 9 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 6 month follow-up | Trace | 3 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 6 month follow-up | Mild | 6 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 6 month follow-up | Moderate | 2 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 6 month follow-up | Severe | 3 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 12 month follow-up | None | 3 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 12 month follow-up | Trace | 6 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 12 month follow-up | Mild | 6 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 12 month follow-up | Moderate | 4 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 12 month follow-up | Severe | 1 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 18 month follow-up | None | 2 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 18 month follow-up | Trace | 4 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 18 month follow-up | Mild | 0 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 18 month follow-up | Moderate | 1 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 18 month follow-up | Severe | 0 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 24 month follow-up | None | 1 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 24 month follow-up | Mild | 3 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 24 month follow-up | Moderate | 3 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 24 month follow-up | Severe | 3 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 30 month follow-up | None | 4 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 30 month follow-up | Trace | 4 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 30 month follow-up | Mild | 0 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 30 month follow-up | Moderate | 2 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 36 month follow-up | None | 1 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 36 month follow-up | Trace | 4 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 36 month follow-up | Mild | 3 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 36 month follow-up | Moderate | 1 Participants |
| Harpoon Medical Device | Subject's Severity of Mitral Regurgitation Over Time | 36 month follow-up | Severe | 2 Participants |