Trial Outcomes & Findings for Safety and Early Feasibility Study of the Harpoon Medical Device (EFS) (NCT NCT02771275)
NCT ID: NCT02771275
Last Updated: 2024-01-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Procedure through 30 days
Results posted on
2024-01-22
Participant Flow
Participant milestones
| Measure |
Harpoon Medical Device
Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Harpoon Medical Device
Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
|
|---|---|
|
Overall Study
Reoperation
|
3
|
|
Overall Study
Exit - subject did not reconsent to extended follow-up
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Harpoon Medical Device
n=13 Participants
Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
|
|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 12.7 • n=13 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: Procedure through 30 daysPopulation: This outcome is reported for subjects who received the Harpoon Medical device where data is available.
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.
Outcome measures
| Measure |
Harpoon Medical Device
n=13 Participants
Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
|
|---|---|
|
Number of Subjects With Procedural Success During the First 30 Days
|
12 Participants
|
PRIMARY outcome
Timeframe: Procedure through 30 daysPopulation: This outcome is reported for subjects who received the Harpoon Medical Device where data is available.
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.
Outcome measures
| Measure |
Harpoon Medical Device
n=13 Participants
Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
|
|---|---|
|
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days
KM estimate: 30 Days
|
84.6 percentage of subjects
|
|
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days
KM estimate: Procedure
|
100.0 percentage of subjects
|
PRIMARY outcome
Timeframe: Discharge, an average of 8 days post implantationPopulation: This outcome is reported for subjects who received the Harpoon Medical Device where data is available.
Number of Participants experiencing a Serious Adverse Event (SAE) through time of Discharge.
Outcome measures
| Measure |
Harpoon Medical Device
n=13 Participants
Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
|
|---|---|
|
Subject's Serious Adverse Events (SAE) Through Discharge
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 months, 24 months, 30 months, and 36 monthsPopulation: This outcome is reported for subjects who received the Harpoon Medical Device where data is available.
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.
Outcome measures
| Measure |
Harpoon Medical Device
n=13 Participants
Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
|
|---|---|
|
Subject's Severity of Mitral Regurgitation Over Time
30 month follow-up · None
|
0 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
30 month follow-up · Trace
|
0 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
30 month follow-up · Mild
|
0 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
30 month follow-up · Moderate
|
1 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
30 month follow-up · Severe
|
0 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
30 - 36 month follow-up · Trace
|
0 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
30 - 36 month follow-up · Mild
|
1 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
30 - 36 month follow-up · Severe
|
0 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
24 month follow-up · Trace
|
3 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
24 month follow-up · Mild
|
3 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
30 - 36 month follow-up · None
|
0 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
30 - 36 month follow-up · Moderate
|
0 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
24 month follow-up · Severe
|
1 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
6 month follow-up · None
|
1 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
6 month follow-up · Trace
|
4 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
6 month follow-up · Mild
|
4 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
6 month follow-up · Moderate
|
2 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
6 month follow-up · Severe
|
1 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
12 month follow-up · None
|
1 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
12 month follow-up · Trace
|
3 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
12 month follow-up · Mild
|
2 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
12 month follow-up · Moderate
|
5 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
12 month follow-up · Severe
|
0 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
18 - 24 month follow-up · None
|
0 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
18 - 24 month follow-up · Trace
|
0 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
18 - 24 month follow-up · Mild
|
0 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
18 - 24 month follow-up · Moderate
|
0 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
18 - 24 month follow-up · Severe
|
1 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
24 month follow-up · None
|
0 Participants
|
|
Subject's Severity of Mitral Regurgitation Over Time
24 month follow-up · Moderate
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 months, 24 months, 30 months, and 36 monthsPopulation: This outcome is reported for subjects who received the Harpoon Medical Device where data is available.
Subject's freedom from Serious Adverse Events at \>30 days post-implant. Time to events were estimated by Kaplan-Meier method.
Outcome measures
| Measure |
Harpoon Medical Device
n=13 Participants
Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
|
|---|---|
|
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
KM estimate:12 months
|
53.8 percentage of subjects
|
|
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
KM estimate: 6 months
|
61.5 percentage of subjects
|
|
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
KM estimate:18 months
|
53.8 percentage of subjects
|
|
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
KM estimate:24 months
|
53.8 percentage of subjects
|
|
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
KM estimate:30 months
|
53.8 percentage of subjects
|
|
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
KM estimate:36 months
|
53.8 percentage of subjects
|
Adverse Events
Harpoon Medical Device
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Harpoon Medical Device
n=13 participants at risk
Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
|
|---|---|
|
Cardiac disorders
Pericardial tamponade
|
15.4%
2/13 • Number of events 2 • Events occurring from baseline through 60 months post implant.
|
|
Musculoskeletal and connective tissue disorders
Infection/Inflammation - Other
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
|
Cardiac disorders
Arterial dissection
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
|
Product Issues
Damage to the native mitral valve apparatus Chord
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
|
Product Issues
Other Study Device Structural Problems
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Left
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
|
Product Issues
EPTFE KNOT PULL-OUT/DETACHMENT (FROM LEAFLET)
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
Other adverse events
| Measure |
Harpoon Medical Device
n=13 participants at risk
Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
|
|---|---|
|
Cardiac disorders
Arrhythmia - Supraventricular Tachycardia (SVT)
|
15.4%
2/13 • Number of events 2 • Events occurring from baseline through 60 months post implant.
|
|
General disorders
Nonspecific, unknown, or other body system - Other complication
|
15.4%
2/13 • Number of events 2 • Events occurring from baseline through 60 months post implant.
|
|
Blood and lymphatic system disorders
Anemia - Non-bleeding related
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
|
Cardiac disorders
Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
|
Blood and lymphatic system disorders
Bleeding - Genitourinary - Major
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
|
Infections and infestations
INFECTION - OTHER LOCALIZED INFECTION
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
|
General disorders
Bone fracture/Break
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
|
General disorders
Other
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
|
Product Issues
Other Access Site Complication - Minor
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
|
Renal and urinary disorders
Renal dysfunction
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
|
Blood and lymphatic system disorders
BLEEDING - CARDIOVASCULAR - MAJOR
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
|
Cardiac disorders
REGURGITATION - MITRAL-INDETERMINATE +4
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION - BILATERAL
|
7.7%
1/13 • Number of events 1 • Events occurring from baseline through 60 months post implant.
|
Additional Information
Sabrina Hundt, Director of Clinical Affairs, Surgical Structural Heart
Edwards Lifesciences, LLC
Phone: 949-250-2500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PI must submit publication 60 days prior to its submission for presentation/publication to Sponsor. The Sponsor may, at its sole discretion, (a) approve the publication, (b) reject the publication, or (c) suggest changes to the publication to ensure protection of confidential commercial information in compliance with regulatory requirements. Until the content of any publication is approved by the Sponsor and the PI, the PI shall not disclose such publication.
- Publication restrictions are in place
Restriction type: OTHER