Skip to main content
OpenTrials
Completed

NCT Number: NCT02771275

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mitral Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Heart Valve Prolapse Mitral Valve Insufficiency Mitral Valve Prolapse

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Paul II University Hospital, Krakow, Poland

Loading trial locations.

About this study

The TSD-5 is intended to secure ePTFE sutures on the mitral valve for the treatment of mitral valve disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All subjects referred for mitral valve surgery
  • Presence of severe mitral regurgitation as read on an echocardiographic study performed within 60 days prior to procedure. Assessment of mitral regurgitation will be performed by the investigational site echocardiography laboratory and confirmed by the Core Echocardiography Laboratory using an integrative method.
  • Age > 18 years
  • Estimated post-ePTFE cordal implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee
  • Degenerative mitral valve disease
  • Subject 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
  • Able to sign informed consent

Exclusion criteria

  • Age < 18 years
  • Infective endocarditis
  • Anterior or bileaflet prolapse
  • Functional mitral regurgitation
  • 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
  • Severely calcified mitral leaflets
  • Recent stroke (< 6 months) with permanent impairment
  • EuroScore (for mitral valve repair) > 8%
  • Subjects with contraindications to transesophageal echocardiography
  • Severe left or right ventricular dysfunction
  • NYHA Class IV
  • Renal insufficiency CKD stage 3b or worse (GFR < 45 ml/min/1.73 m2)
  • Patient is participating in another clinical study for which follow-up is currently ongoing. (Co-enrollment in an investigational device or interventional study)
  • Patient with non-cardiac co-morbidities and life expectancy < 1 year
  • Patient has a condition or conditions that, in the opinion of the Investigator, preclude participation, including willingness to comply with all follow-up procedures

Treatment and study plan

Harpoon Medical Device

Device

It is expected that the Harpoon Medical transapical suturing device will be a valuable treatment alternative for patients suffering from mitral valve regurgitation because it can access the left ventricle with a small shaft or via a small valved introducer with a secure anchoring mechanism that can be deployed anywhere on the mitral valve leaflet.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Subject's Serious Adverse Events (SAE) Through Discharge

    Time frame: Discharge, an average of 8 days post implantation

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

Secondary outcomes

  1. Subject's Severity of Mitral Regurgitation Over Time

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

Safety and Performance Study of the Harpoon Medical Transapical Suturing Device (TSD-5) in Subjects With Degenerative Mitral Regurgitation - EFS/CE Mark Study for the Harpoon Medical Device in Poland

Acronym: EFS

Important dates

Study start
2015
Primary completion
2016
Study completion
2021
First posted
May 13, 2016
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.