NCT02771275: EFS

Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)

Completed NA Results posted Last updated 22 January 2024

What this trial tests

NA trial testing Harpoon Medical Device in Mitral Valve Regurgitation in 13 participants. Completed in 16 July 2021.

Timeline

15 February 2015

Primary endpoint
21 March 2016

16 July 2021

Quick facts

Lead sponsor	Edwards Lifesciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	15 February 2015
Primary completion	21 March 2016
Estimated completion	16 July 2021
Sites	2 locations across Poland

Drugs / interventions tested

• Harpoon Medical Device

Conditions studied

• Mitral Valve Regurgitation — all drugs for Mitral Valve Regurgitation →
• Mitral Valve Prolapse — all drugs for Mitral Valve Prolapse →
• Mitral Valve Insufficiency — all drugs for Mitral Valve Insufficiency →

Sponsor

Edwards Lifesciences — full company profile →

Who can join

18 and older, any sex, with Mitral Valve Regurgitation or Mitral Valve Prolapse. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Procedural Success During the First 30 Days Primary · 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.

Group	Value	95% CI
Harpoon Medical Device	12

Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days Primary · Procedure through 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.

KM estimate: Procedure

Group	Value	95% CI
Harpoon Medical Device	100.0

KM estimate: 30 Days

Group	Value	95% CI
Harpoon Medical Device	84.6

Subject's Serious Adverse Events (SAE) Through Discharge Primary · Discharge, an average of 8 days post implantation

Number of Participants experiencing a Serious Adverse Event (SAE) through time of Discharge.

Group	Value	95% CI
Harpoon Medical Device	1

Subject's Severity of Mitral Regurgitation Over Time Secondary · 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.

6 month follow-up

Group	Value	95% CI
Harpoon Medical Device	1
Harpoon Medical Device	4
Harpoon Medical Device	4
Harpoon Medical Device	2

12 month follow-up

Group	Value	95% CI
Harpoon Medical Device	1
Harpoon Medical Device	3
Harpoon Medical Device	2
Harpoon Medical Device	5

18 - 24 month follow-up

Group	Value	95% CI
Harpoon Medical Device	0
Harpoon Medical Device	0
Harpoon Medical Device	0
Harpoon Medical Device	0

24 month follow-up

Group	Value	95% CI
Harpoon Medical Device	0
Harpoon Medical Device	3
Harpoon Medical Device	3
Harpoon Medical Device	4

30 month follow-up

Group	Value	95% CI
Harpoon Medical Device	0
Harpoon Medical Device	0
Harpoon Medical Device	0
Harpoon Medical Device	1

30 - 36 month follow-up

Group	Value	95% CI
Harpoon Medical Device	0
Harpoon Medical Device	0
Harpoon Medical Device	1
Harpoon Medical Device	0

Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days Secondary · 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.

KM estimate: 6 months

Group	Value	95% CI
Harpoon Medical Device	61.5

KM estimate:12 months

Group	Value	95% CI
Harpoon Medical Device	53.8

KM estimate:18 months

Group	Value	95% CI
Harpoon Medical Device	53.8

KM estimate:24 months

Group	Value	95% CI
Harpoon Medical Device	53.8

KM estimate:30 months

Group	Value	95% CI
Harpoon Medical Device	53.8

KM estimate:36 months

Group	Value	95% CI
Harpoon Medical Device	53.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Events occurring from baseline through 60 months post implant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Harpoon Medical Device

Serious: 6/13 (46%)

Deaths: 0/13

Serious adverse events (7 terms)

Reaction	System	Harpoon Medical Device
Pericardial tamponade	Cardiac disorders	—
Infection/Inflammation - Other	Musculoskeletal and connective tissue disorders	—
Arterial dissection	Cardiac disorders	—
Damage to the native mitral valve apparatus Chord	Product Issues	—
Other Study Device Structural Problems	Product Issues	—
Pleural effusion - Left	Respiratory, thoracic and mediastinal disorders	—
EPTFE KNOT PULL-OUT/DETACHMENT (FROM LEAFLET)	Product Issues	—

Other adverse events (13 terms — click to expand)

Reaction	System	Harpoon Medical Device
Arrhythmia - Supraventricular Tachycardia (SVT)	Cardiac disorders	—
Nonspecific, unknown, or other body system - Other complication	General disorders	—
Anemia - Non-bleeding related	Blood and lymphatic system disorders	—
Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)	Cardiac disorders	—
Bleeding - Genitourinary - Major	Blood and lymphatic system disorders	—
INFECTION - OTHER LOCALIZED INFECTION	Infections and infestations	—
Bone fracture/Break	General disorders	—
Other	General disorders	—
Other Access Site Complication - Minor	Product Issues	—
Renal dysfunction	Renal and urinary disorders	—
BLEEDING - CARDIOVASCULAR - MAJOR	Blood and lymphatic system disorders	—
REGURGITATION - MITRAL-INDETERMINATE +4	Cardiac disorders	—
PLEURAL EFFUSION - BILATERAL	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Pericardial tamponade, Infection/Inflammation - Other, Arterial dissection, Damage to the native mitral valve apparatus Chord, Other Study Device Structural Problems, Pleural effusion - Left, EPTFE KNOT PULL-OUT/DETACHMENT (FROM LEAFLET).

Data from ClinicalTrials.gov NCT02771275 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant 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 TEE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.