Trial Outcomes & Findings for Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device. (NCT NCT04382612)
NCT ID: NCT04382612
Last Updated: 2023-12-22
Results Overview
Subject's freedom from all-cause mortality, disabling stroke and life-threatening bleeding at 30 days post-implant.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
30 days
Results posted on
2023-12-22
Participant Flow
Participant milestones
| Measure |
HARPOON MVRS
The enrolled cohort with the HARPOON MVRS.
HARPOON Beating Heart Mitral Valve Repair System (MVRS): Repair of the chordae tendinae in the mitral valve.
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
HARPOON MVRS
The enrolled cohort with the HARPOON MVRS.
HARPOON Beating Heart Mitral Valve Repair System (MVRS): Repair of the chordae tendinae in the mitral valve.
|
|---|---|
|
Overall Study
Screen failure - no attempt to use the device
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
HARPOON MVRS
n=41 Participants
The attempt to treat cohort with the HARPOON MVRS.
HARPOON Beating Heart Mitral Valve Repair System (MVRS): Repair of the chordae tendinae in the mitral valve.
|
|---|---|
|
Age, Continuous
|
67.2 Years
STANDARD_DEVIATION 11.75 • n=41 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: This outcome is reported as a Kaplan Meier estimate for subjects who were attempted to be treated in the trial where data is available. The number of participants analyzed at the 30-day timepoint is equivalent to the number of patients at risk at that timepoint.
Subject's freedom from all-cause mortality, disabling stroke and life-threatening bleeding at 30 days post-implant.
Outcome measures
| Measure |
HARPOON MVRS
n=38 Participants
The attempt to treat cohort with the HARPOON MVRS.
HARPOON Beating Heart Mitral Valve Repair System (MVRS): Repair of the chordae tendinae in the mitral valve.
|
|---|---|
|
Percentage of Subject's With Freedom From All-cause Mortality, Disabling Stroke and Life-threatening Bleeding
|
97.6 percentage of subjects
Interval 92.8 to 100.0
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PRIMARY outcome
Timeframe: 30 daysPopulation: Subjects who completed a 30-day follow-up. The outcome is reported for subjects where data is available.
Subject's procedural success at 30 days post-treatment, as measured by: Technical success (defined as implantation of at least three chords, leaving the operating room and no conversion to open heart surgery) with reduction of MR to less than or equal to mild and the absence of major device or procedure-related SAEs.
Outcome measures
| Measure |
HARPOON MVRS
n=38 Participants
The attempt to treat cohort with the HARPOON MVRS.
HARPOON Beating Heart Mitral Valve Repair System (MVRS): Repair of the chordae tendinae in the mitral valve.
|
|---|---|
|
Number of Subjects With Procedural Success During the First 30 Days
|
26 Participants
|
Adverse Events
HARPOON MVRS
Serious events: 15 serious events
Other events: 20 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
HARPOON MVRS
n=42 participants at risk
The enrolled cohort of the ASCEND trial.
|
|---|---|
|
Blood and lymphatic system disorders
BLEEDING - INTRACARDIAC/INTRATHORACIC INJURY DURING INDEX PROCEDURE
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
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Cardiac disorders
ARRHYTHMIA - TACHYCARDIA - VENTRICULAR
|
4.8%
2/42 • Number of events 2 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Cardiac disorders
ARRHYTHMIA - BRADYCARDIA
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Cardiac disorders
ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
4.8%
2/42 • Number of events 2 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Cardiac disorders
PERICARDITIS
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Cardiac disorders
REGURGITATION - RECURRENT MITRAL SEVERE
|
11.9%
5/42 • Number of events 5 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Product Issues
DEVICE SPECIFIC COMPLICATION - EPTFE KNOT PULL-OUT/DETACHMENT (FROM LEAFLET)
|
4.8%
2/42 • Number of events 2 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Product Issues
DEVICE SPECIFIC COMPLICATION - OTHER CHORD/KNOT STRUCTURAL PROBLEMS
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY/RENAL INSUFFICIENCY
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Musculoskeletal and connective tissue disorders
BONE FRACTURE/BREAK
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
General disorders
OTHER - NONSPECIFIC
|
4.8%
2/42 • Number of events 2 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
4.8%
2/42 • Number of events 3 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY COMPLICATION - PNEUMOTHORAX
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
Other adverse events
| Measure |
HARPOON MVRS
n=42 participants at risk
The enrolled cohort of the ASCEND trial.
|
|---|---|
|
Vascular disorders
ACCESS SITE AND VASCULAR COMPLICATIONS - OTHER MINOR
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Blood and lymphatic system disorders
ANEMIA - NON-BLEEDING RELATED
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Cardiac disorders
ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
|
16.7%
7/42 • Number of events 7 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Cardiac disorders
ARRHYTHMIA - BRADYCARDIA
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Cardiac disorders
ARRHYTHMIA - OTHER
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Cardiac disorders
REGURGITATION - RECURRENT MITRAL MODERATE
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Cardiac disorders
REGURGITATION - RECURRENT MITRAL SEVERE
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Product Issues
DEVICE SPECIFIC COMPLICATION - EPTFE KNOT PULL-OUT/DETACHMENT (FROM LEAFLET)
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR SKELETAL/DERMATOLOGIC - OTHER
|
4.8%
2/42 • Number of events 2 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Cardiac disorders
NEUROLOGICAL EVENT - TRANSIENT ISCHEMIC ATTACK (TIA)
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Infections and infestations
INFECTION/INFLAMMATION - OTHER
|
7.1%
3/42 • Number of events 4 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
General disorders
OTHER - NONSPECIFIC
|
4.8%
2/42 • Number of events 2 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
General disorders
ALLERGIC REACTION - OTHER
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
General disorders
FEVER - UNKNOWN ORIGIN
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Psychiatric disorders
PSYCHIATRIC - OTHER
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Psychiatric disorders
PSYCHIATRIC DISORDER
|
2.4%
1/42 • Number of events 1 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
11.9%
5/42 • Number of events 5 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY COMPLICATION - PNEUMOTHORAX
|
4.8%
2/42 • Number of events 2 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY INFECTION - UPPER (URI)
|
4.8%
2/42 • Number of events 2 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/RESPIRATORY - OTHER
|
2.4%
1/42 • Number of events 2 • Adverse events occurring from baseline through 24 months post implant of the enrolled cohort.
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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 can't publish/present on overall study results not yet published but may publish his own data subject to EW review prior to submission/presentation to ensure proprietary information shall not be divulged. Publication/presentation of the PI's site-specific results of devices which haven't been market released and which still may be undergoing development, shall not include claims of device safety/effectiveness and will require the review/approval of EW.
- Publication restrictions are in place
Restriction type: OTHER