Back to resultsCE Mark Study for the Harpoon Medical Device in Poland
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
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Valve Regurgitation focused on measuring Mitral Valve Repair, Transapical, artificial chordae
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
Sites / Locations
- John Paul II University Hospital
- Instytut of Kardiologii & Transplantology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Harpoon Medical 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
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.
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
1. Study Identification
Unique Protocol Identification Number
NCT02432196
Brief Title
CE Mark Study for the Harpoon Medical Device in Poland
Official Title
Safety and Performance Study of the Harpoon Medical Transapical Suturing Device (TSD-5) in Subjects With Degenerative Mitral Regurgitation - 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
December 11, 2015 (Actual)
Primary Completion Date
February 8, 2018 (Actual)
Study Completion Date
November 16, 2022 (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
No
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
No
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
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Harpoon Medical TSD-5
Arm Type
Experimental
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.
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
Subject's Procedural Success During the First 30 Days
Description
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.
Time Frame
Procedure and 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 6 days post implant
Secondary Outcome Measure Information:
Title
Subject's Severity of Mitral Regurgitation Over Time
Description
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.
Time Frame
6 months, 12 months, 18 months, and 24 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Piotr Kolsut, 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
No
IPD Sharing Plan Description
Individual participant data will not be available to other researchers.
Citations:
PubMed Identifier
27436878
Citation
Gammie JS, Wilson P, Bartus K, Gackowski A, Hung J, D'Ambra MN, Kolsut P, Bittle GJ, Szymanski P, Sadowski J, Kapelak B, Bilewska A, Kusmierczyk M, Ghoreishi M. Transapical Beating-Heart Mitral Valve Repair With an Expanded Polytetrafluoroethylene Cordal Implantation Device: Initial Clinical Experience. Circulation. 2016 Jul 19;134(3):189-97. doi: 10.1161/CIRCULATIONAHA.116.022010.
Results Reference
result
PubMed Identifier
33038223
Citation
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.
Results Reference
derived
PubMed Identifier
27777278
Citation
Goto Y, Funada A, Goto Y. Duration of Prehospital Cardiopulmonary Resuscitation and Favorable Neurological Outcomes for Pediatric Out-of-Hospital Cardiac Arrests: A Nationwide, Population-Based Cohort Study. Circulation. 2016 Dec 20;134(25):2046-2059. doi: 10.1161/CIRCULATIONAHA.116.023821. Epub 2016 Oct 24.
Results Reference
derived
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CE Mark Study for the Harpoon Medical Device in Poland
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