Trial Outcomes & Findings for Safety and Performance Study of the Harpoon Mitral Valve Repair System (NCT NCT03285724)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

Procedure, discharge, and 30 days

Results posted on

2019-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	Harpoon Medical Device Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Harpoon Medical Device n=1 Participants Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
Age, Customized Age	70 years n=1 Participants
Sex: Female, Male Female	1 Participants n=1 Participants
Sex: Female, Male Male	0 Participants n=1 Participants

PRIMARY outcome

Timeframe: Procedure, discharge, and 30 days

Population: Subject was not implanted with study Device

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.

Outcome measures

Outcome measures
Measure	Harpoon Medical Device n=1 Participants Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
Number of Subjects With Procedural Success During the First 30 Days Procedure	0 Participants
Number of Subjects With Procedural Success During the First 30 Days Discharge	0 Participants
Number of Subjects With Procedural Success During the First 30 Days 30 days follow-up	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Harpoon Medical Device n=1 Participants Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days Procedure	0 Participants
Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days Discharge	0 Participants
Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days 30 Days	0 Participants

SECONDARY outcome

Timeframe: 6 Months, 12 Months, and 24 Months

Population: Participant did not receive the Harpoon Medical Device.

Severity of mitral regurgitation at 6 months, 12 months and 24 months follow-up shall be tracked and recorded

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 Months, 12 Months, and 24 Months

Population: Participant did not receive the Harpoon Medical Device.

Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded

Outcome measures

Outcome data not reported

Adverse Events

Harpoon Medical Device

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Harpoon Medical Device n=1 participants at risk Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
Cardiac disorders Implantation cord failure, mitral ring damage	100.0% 1/1 • Number of events 1 • Events occurring from baseline through end of procedure. Participant did not receive the Harpoon Medical Device.

Other adverse events

Adverse event data not reported

Additional Information

Andrey Nersesov, Sr. 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