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

Primary Purpose

Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency

Status

Completed

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Harpoon Medical Device

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation focused on measuring Mitral Valve Repair, Transapical, Artificial Chordae

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

John Paul II University Hospital
Instytut of Kardiologii & Transplantology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Harpoon Medical Device TSD-5

Arm Description

This is a prospective, nonrandomized, single-centered European study designed single arm study to demonstrate the performance and safety of the Harpoon Medical TSD-5 in Subjects with degenerative mitral regurgitation.

Outcomes

Primary Outcome Measures

Number of Subjects With 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.

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.

Subject's Serious Adverse Events (SAE) Through Discharge

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

Secondary Outcome Measures

Subject's Severity of Mitral Regurgitation Over Time

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.

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

Subject's freedom from Serious Adverse Events at >30 days post-implant. Time to events were estimated by Kaplan-Meier method.

Full Information

NCT ID

NCT02771275

First Posted

April 20, 2016

Last Updated

April 10, 2023

Sponsor

Edwards Lifesciences

1. Study Identification

Unique Protocol Identification Number

NCT02771275

Brief Title

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

Acronym

EFS

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

February 15, 2015 (Actual)

Primary Completion Date

March 21, 2016 (Actual)

Study Completion Date

July 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency

Keywords

Mitral Valve Repair, Transapical, Artificial Chordae

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Harpoon Medical Device TSD-5

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Harpoon Medical Device

Intervention Description

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 Outcome Measure Information:

Title

Number of Subjects With Procedural Success During the First 30 Days

Description

Time Frame

30 days

Title

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

Description

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.

Time Frame

Procedure and 30 days

Title

Subject's Serious Adverse Events (SAE) Through Discharge

Description

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

Time Frame

Discharge, an average of 8 days post implantation

Secondary Outcome Measure Information:

Title

Subject's Severity of Mitral Regurgitation Over Time

Description

Time Frame

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

Title

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

Description

Subject's freedom from Serious Adverse Events at >30 days post-implant. Time to events were estimated by Kaplan-Meier method.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boguslaw Kapelak, MD, PhD

Organizational Affiliation

John Paul II University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mariuz Kusmierczyk, MD, PhD

Organizational Affiliation

Instytut of Kardiologii & Transplantology

Official's Role

Principal Investigator

Facility Information:

Facility Name

John Paul II University Hospital

City

Krakow

ZIP/Postal Code

31-202

Country

Poland

Facility Name

Instytut of Kardiologii & Transplantology

City

Warsaw

ZIP/Postal Code

04-628

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual participant data will not be available to other researchers.

Learn more about this trial

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

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