Trial Outcomes & Findings for Observational Registry on the HARPOON Device (NCT NCT04393779)

Results Overview

Subject's freedom from re-operation due to recurrent severe mitral regurgitation through 1-year post-implant

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

1 year post-implant

Results posted on

2024-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	HARPOON™ MVRS Subjects who were treated with the HARPOON MVRS. HARPOON Beating Heart Mitral Valve Repair System (MVRS): Repair of the chordae tendinae in the mitral valve.
Overall Study STARTED	26
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	HARPOON™ MVRS Subjects who were treated with the HARPOON MVRS. HARPOON Beating Heart Mitral Valve Repair System (MVRS): Repair of the chordae tendinae in the mitral valve.
Overall Study Death	1
Overall Study Device reintervention or explant	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HARPOON™ MVRS n=26 Participants Subjects who were treated with the HARPOON MVRS. HARPOON Beating Heart Mitral Valve Repair System (MVRS): Repair of the chordae tendinae in the mitral valve.
Age, Continuous	65.7 Years STANDARD_DEVIATION 10.87 • n=26 Participants
Sex: Female, Male Female	4 Participants n=26 Participants
Sex: Female, Male Male	22 Participants n=26 Participants

PRIMARY outcome

Timeframe: 1 year post-implant

Population: 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 1-year timepoint is equivalent to the number of patients at risk at that timepoint.

Subject's freedom from re-operation due to recurrent severe mitral regurgitation through 1-year post-implant

Outcome measures

Outcome measures
Measure	HARPOON™ MVRS n=15 Participants Subjects who were treated with the HARPOON MVRS. HARPOON Beating Heart Mitral Valve Repair System (MVRS): Repair of the chordae tendinae in the mitral valve.
Freedom From Re-operation Due to Recurrent Severe Mitral Regurgitation Through 1-year Post-implant	81.0 Percent of participants

Adverse Events

HARPOON™ MVRS

Serious events: 6 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	HARPOON™ MVRS n=26 participants at risk Subjects who were treated with the HARPOON MVRS. HARPOON Beating Heart Mitral Valve Repair System (MVRS): Repair of the chordae tendinae in the mitral valve.
Vascular disorders ACCESS SITE AND VASCULAR COMPLICATIONS - DAMAGE TO THE NATIVE MITRAL VALVE APPARATUS - CHORD	3.8% 1/26 • Number of events 1 • Adverse events occurring from baseline through 25 months post implant of the enrolled cohort.
Blood and lymphatic system disorders BLOOD SEPSIS	3.8% 1/26 • Number of events 1 • Adverse events occurring from baseline through 25 months post implant of the enrolled cohort.
Cardiac disorders REGURGITATION - RECURRENT MITRAL SEVERE	15.4% 4/26 • Number of events 4 • Adverse events occurring from baseline through 25 months post implant of the enrolled cohort.
Product Issues DEVICE SPECIFIC COMPLICATION - OTHER CHORD/KNOT PROBLEMS	3.8% 1/26 • Number of events 1 • Adverse events occurring from baseline through 25 months post implant of the enrolled cohort.

Other adverse events

Other adverse events
Measure	HARPOON™ MVRS n=26 participants at risk Subjects who were treated with the HARPOON MVRS. HARPOON Beating Heart Mitral Valve Repair System (MVRS): Repair of the chordae tendinae in the mitral valve.
Cardiac disorders REGURGITATION - RECURRENT MITRAL MODERATE	3.8% 1/26 • Number of events 2 • Adverse events occurring from baseline through 25 months post implant of the enrolled cohort.
Product Issues DEVICE SPECIFIC COMPLICATION - OTHER CHORD/KNOT PROBLEMS	3.8% 1/26 • Number of events 1 • Adverse events occurring from baseline through 25 months post implant of the enrolled cohort.

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