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CE Mark Study for the Harpoon Medical Device (TRACER)

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ClinicalTrials.gov Identifier: NCT02768870
Recruitment Status : Active, not recruiting
First Posted : May 11, 2016
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

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.

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Mitral Valve Prolapse Mitral Valve Insufficiency Device: Harpoon Artificial ePTFE Chords Not Applicable

Detailed Description:
The device is designed to reduce the degree of mitral regurgitation by delivering and anchoring artificial chordae tendineae to the affected mitral valve leaflet(s) in a beating heart.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mitral TRans-Apical neoChordal Echo-guided Repair (TRACER) Trial
Actual Study Start Date : April 2016
Actual Primary Completion Date : November 2017
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Harpoon Medical Device
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
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.




Primary Outcome Measures :
  1. Procedural success during the first 30 days [ Time Frame: 30 days ]
    To demonstrate that the Harpoon Medical device performs as designed and has the ability to successfully implant one or more ePTFE chordae tendineae on 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.

  2. Freedom from SAE's during the first 30 days [ Time Frame: 30 days ]
    Procedure freedom from Serious Adverse Events (SAEs) during the ePTFE implantation procedure, at discharge, and at 30 days follow-up shall be tracked and recorded. Rates are expected to be not significantly worse than conventional mitral valve surgery.


Secondary Outcome Measures :
  1. Long Term Procedural Success [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months ]
    Severity of mitral regurgitation at 6 months, 12 months, 18 months, 24 months, 30 months and 36 months follow-up shall be tracked and recorded.

  2. Freedom from SAE's post implant > 30 days [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months ]
    Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months, 18 months, 24 months, 30 months and 36 months follow-up shall be tracked and recorded.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Severely calcified mitral leaflets
  • Recent stroke (< 6 months) with permanent impairment
  • EuroScore (for mitral valve repair) > 8%
  • Patients with contraindications to Transoesophageal 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768870


Locations
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Italy
Ospedale San Raffaele Hospital
Milan, Italy, 20132
University Hospital Padova
Padova, Italy, 351278
United Kingdom
The Royal Brompton and Harefield NHS Foundation Trust
London, United Kingdom, SH3 6NP
University Hospital Southampton NHS Trust
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Gino Gerosa, MD University Hospital Padova
Principal Investigator: Ottavio Alfieri, MD OSR San Raffaele Hospital
Principal Investigator: Alison Duncan, MD The Royal Brompton Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02768870     History of Changes
Other Study ID Numbers: HMCE-1002j
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Edwards Lifesciences:
Mitral Valve Repair
Transapical
Artificial Chordae
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Mitral Valve Prolapse
Prolapse
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Heart Valve Prolapse