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

Sponsor
Edwards Lifesciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02771275
Collaborator
(none)
13
2
1
65.4
6.5
0.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Harpoon Medical Device
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Jul 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Harpoon Medical Device TSD-5

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.

Device: Harpoon Medical 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.

Outcome Measures

Primary Outcome Measures

  1. Number of Subjects With Procedural Success During the First 30 Days [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 [Procedure and 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 [Discharge, an average of 8 days post implantation]

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

Secondary Outcome Measures

  1. Subject's Severity of Mitral Regurgitation Over Time [6 months, 12 months, 18 months, 24 months, and 30 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 [6 months, 12 months, 18 months, 24 months, and 30 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 John Paul II University Hospital Krakow Poland 31-202
2 Instytut of Kardiologii & Transplantology Warsaw Poland 04-628

Sponsors and Collaborators

  • Edwards Lifesciences

Investigators

  • Principal Investigator: Boguslaw Kapelak, MD, PhD, John Paul II University Hospital
  • Principal Investigator: Mariuz Kusmierczyk, MD, PhD, Instytut of Kardiologii & Transplantology

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT02771275
Other Study ID Numbers:
  • HMFIM-1000-PL-04
First Posted:
May 13, 2016
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Edwards Lifesciences
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Harpoon Medical Device
Arm/Group Description Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
Period Title: Overall Study
STARTED 13
COMPLETED 0
NOT COMPLETED 13

Baseline Characteristics

Arm/Group Title Harpoon Medical Device
Arm/Group Description Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
Overall Participants 13
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
65.9
(12.7)
Sex: Female, Male (Count of Participants)
Female
3
23.1%
Male
10
76.9%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome
Title Number of Subjects With 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 30 days

Outcome Measure Data

Analysis Population Description
This outcome is reported for enrolled subjects where data is available.
Arm/Group Title Harpoon Medical Device
Arm/Group Description Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
Measure Participants 13
Count of Participants [Participants]
12
92.3%
2. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
This outcome is reported for subjects who received the Harpoon Medical Device where data is available.
Arm/Group Title Harpoon Medical Device
Arm/Group Description Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
Measure Participants 13
KM estimate: Procedure
100.0
KM estimate: 30 Days
84.6
3. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
This outcome is reported for subjects who received the Harpoon Medical Device where data is available.
Arm/Group Title Harpoon Medical Device
Arm/Group Description Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
Measure Participants 13
Count of Participants [Participants]
1
7.7%
4. Secondary Outcome
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, 24 months, and 30 months

Outcome Measure Data

Analysis Population Description
This outcome is reported for subjects who received the Harpoon Medical Device where data is available.
Arm/Group Title Harpoon Medical Device
Arm/Group Description Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
Measure Participants 13
None
1
7.7%
Trace
4
30.8%
Mild
4
30.8%
Moderate
2
15.4%
Severe
1
7.7%
None
1
7.7%
Trace
3
23.1%
Mild
2
15.4%
Moderate
5
38.5%
Severe
0
0%
None
0
0%
Trace
3
23.1%
Mild
3
23.1%
Moderate
4
30.8%
Severe
1
7.7%
None
0
0%
Trace
0
0%
Mild
0
0%
Moderate
1
7.7%
Severe
0
0%
5. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
This outcome is reported for subjects who received the Harpoon Medical Device where data is available.
Arm/Group Title Harpoon Medical Device
Arm/Group Description Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
Measure Participants 13
KM estimate: 6 months
61.5
KM estimate:12 months
53.8
KM estimate:18 months
53.8
KM estimate:24 months
53.8
KM estimate:30 months
53.8

Adverse Events

Time Frame Events occurring from baseline through 30 months post implant.
Adverse Event Reporting Description
Arm/Group Title Harpoon Medical Device
Arm/Group Description Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
All Cause Mortality
Harpoon Medical Device
Affected / at Risk (%) # Events
Total 0/13 (0%)
Serious Adverse Events
Harpoon Medical Device
Affected / at Risk (%) # Events
Total 6/13 (46.2%)
Cardiac disorders
Pericardial tamponade 2/13 (15.4%) 2
Arterial dissection 1/13 (7.7%) 1
Musculoskeletal and connective tissue disorders
Infection/Inflammation - Other 1/13 (7.7%) 2
Product Issues
Damage to the native mitral valve apparatus Chord 1/13 (7.7%) 1
Other Study Device Structural Problems 1/13 (7.7%) 1
ePTFE cordal rupture 1/13 (7.7%) 1
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Left 1/13 (7.7%) 1
Other (Not Including Serious) Adverse Events
Harpoon Medical Device
Affected / at Risk (%) # Events
Total 7/13 (53.8%)
Blood and lymphatic system disorders
Anemia - Non-bleeding related 1/13 (7.7%) 1
Bleeding - Genitourinary - Major 1/13 (7.7%) 1
Bleeding Event - Blood Transfusion 1/13 (7.7%) 1
Cardiac disorders
Arrhythmia - Supraventricular Tachycardia (SVT) 2/13 (15.4%) 2
Arrhythmia - Paroxysmal Atrial Fibrillation (PAF) 1/13 (7.7%) 1
General disorders
Nonspecific, unknown, or other body system - Other complication 2/13 (15.4%) 2
Bone fracture/Break 1/13 (7.7%) 1
Muscular skeletal/Dermatologic - Other 1/13 (7.7%) 1
Product Issues
Other Access Site Complication - Minor 1/13 (7.7%) 1
Renal and urinary disorders
Renal dysfunction 1/13 (7.7%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

PI must submit publication 60 days prior to its submission for presentation/publication to Sponsor. The Sponsor may, at its sole discretion, (a) approve the publication, (b) reject the publication, or (c) suggest changes to the publication to ensure protection of confidential commercial information in compliance with regulatory requirements. Until the content of any publication is approved by the Sponsor and the PI, the PI shall not disclose such publication.

Results Point of Contact

Name/Title Andrey Nersesov, Sr. Director of Clinical Affairs, Surgical Structural Heart
Organization Edwards Lifesciences, LLC
Phone 949-250-2500 ext 0225
Email Andrey_Nersesov@edwards.com
Responsible Party:
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT02771275
Other Study ID Numbers:
  • HMFIM-1000-PL-04
First Posted:
May 13, 2016
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022