NCT02768870

Brief Summary

The purpose of this study is to evaluate the safety and performance of the Harpoon Medical device. It is anticipated, that the Harpoon Medical device will provide 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 TOE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

April 28, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

November 25, 2019

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2022

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

April 20, 2016

Results QC Date

September 23, 2019

Last Update Submit

January 10, 2024

Conditions

Mitral Valve RegurgitationMitral Valve ProlapseMitral Valve Insufficiency

Keywords

Mitral Valve RepairTransapicalArtificial Chordae

Outcome Measures

Primary Outcomes (3)

  • Subject's Procedural Success During the First 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.

    End of procedure through 30 days

  • Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 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.

    Procedure and 30 days

  • Subject's Serious Adverse Events (SAE) Through Discharge

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

    Discharge, an average of 5 days post implant

Secondary Outcomes (2)

  • Subject's Severity of Mitral Regurgitation Over Time

    6 months, 12 months, 18 months, 24 months, 30 months, and 36 months

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

    6 months, 12 months, 18 months, 24 months, 30 months, and 36 months

Study Arms (1)

Harpoon Medical Device

EXPERIMENTAL

This is a prospective, single arm, nonrandomised, multi-center EU study to demonstrate the performance and safety of the Harpoon Medical device in patients with degenerative MR.

Device: Harpoon Artificial ePTFE Chords

Interventions

Harpoon Artificial ePTFE ChordsDEVICE

It is anticipated that use of the Harpoon device could achieve similar outcomes to open cardiac surgery while decreasing the invasiveness of mitral valve repair.

Harpoon Medical Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Patient referred for mitral valve surgery
  • Presence of severe MR as read on an echocardiographic study performed within 60 days prior to procedure
  • Estimated post-ePTFE chordae tendineae implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee
  • Degenerative mitral valve disease
  • Patient is able to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation
  • Women of child-bearing potential have a negative pregnancy test

You may not qualify if:

  • Age \< 18 years
  • Infective endocarditis
  • Anterior or bileaflet prolapse
  • Functional MR
  • History of Mediastinal Radiation
  • Inflammatory (rheumatic) valve disease
  • Requirement for concomitant cardiac surgery (e.g., coronary artery bypass grafting (CABG), aortic valve surgery, etc.)
  • Symptomatic coronary artery disease
  • Cardiogenic shock at the time of enrollment
  • ST segment elevation myocardial infarction requiring intervention within 30 days prior to enrollment
  • Evidence of cirrhosis or hepatic synthetic failure
  • Pregnancy at the time of enrollment (women of child bearing age should have negative pregnancy within 14 days of surgery)
  • Severe pulmonary hypertension (PA systolic pressure \> 70 mmHg)
  • Previous cardiac surgery, or surgery on the left pleural space
  • Left ventricular, atrial or appendage thrombus
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ospedale San Raffaele Hospital

Milan, 20132, Italy

Location

University Hospital Padova

Padua, 351278, Italy

Location

The Royal Brompton and Harefield NHS Foundation Trust

London, SH3 6NP, United Kingdom

Location

University Hospital Southampton NHS Trust

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (2)

  • Gammie JS, Bartus K, Gackowski A, D'Ambra MN, Szymanski P, Bilewska A, Kusmierczyk M, Kapelak B, Rzucidlo-Resil J, Moat N, Duncan A, Yadev R, Livesey S, Diprose P, Gerosa G, D'Onofrio A, Pitterello D, Denti P, La Canna G, De Bonis M, Alfieri O, Hung J, Kolsut P. Beating-Heart Mitral Valve Repair Using a Novel ePTFE Cordal Implantation Device: A Prospective Trial. J Am Coll Cardiol. 2018 Jan 2;71(1):25-36. doi: 10.1016/j.jacc.2017.10.062. Epub 2017 Nov 1.

    PMID: 29102688RESULT

  • Gammie JS, Bartus K, Gackowski A, Szymanski P, Bilewska A, Kusmierczyk M, Kapelak B, Rzucidlo-Resil J, Duncan A, Yadav R, Livesey S, Diprose P, Gerosa G, D'Onofrio A, Pittarello D, Denti P, La Canna G, De Bonis M, Alfieri O, Hung J, Kolsut P, D'Ambra MN. Safety and performance of a novel transventricular beating heart mitral valve repair system: 1-year outcomes. Eur J Cardiothorac Surg. 2021 Jan 4;59(1):199-206. doi: 10.1093/ejcts/ezaa256.

    PMID: 33038223DERIVED

MeSH Terms

Conditions

Mitral Valve InsufficiencyMitral Valve Prolapse

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesHeart Valve Prolapse

Results Point of Contact

Title
Sabrina Hundt, Director, Clinical Affairs, Surgical Structural Heart
Organization
Edwards Lifesciences, LLC
Sabrina_Hundt@edwards.com
949-250-2500

Study Officials

  • Gino Gerosa, MD

    University Hospital Padova

    PRINCIPAL INVESTIGATOR

  • Ottavio Alfieri, MD

    OSR San Raffaele Hospital

    PRINCIPAL INVESTIGATOR

  • Alison Duncan, MD

    The Royal Brompton Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2016

First Posted

May 11, 2016

Study Start

April 28, 2016

Primary Completion

November 6, 2017

Study Completion

September 6, 2022

Last Updated

January 11, 2024

Results First Posted

November 25, 2019

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be available to other researchers.

Locations

IT(2)GB(2)