Safety and Performance Study of the Harpoon Mitral Valve Repair System

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03285724
• Collaborator: (none)
• Enrollment: 1
• Locations: 2
• Arm: 1
• Actual Duration (Months): 11.1
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The primary objective 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 TEE-guided ePTFE cordal 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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single Group AssignmentSingle Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Performance Study of the Harpoon Medical Device in Patients With Degenerative Mitral Regurgitation
• Actual Study Start Date: May 16, 2017
• Actual Primary Completion Date: Jun 16, 2017
• Actual Study Completion Date: Apr 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Harpoon Medical Transapical device TSD-5 This is a prospective, single arm, nonrandomized, early feasibility study to evaluate the safety and performance of the Harpoon Medical Device.	Device: Harpoon Artificial ePTFE Chords; The Harpoon Medical Transapical device is intended to be used to reduce the degree of degenerative mitral regurgitation by delivering and anchoring one or more ePTFE cords to the affected mitral valve leaflet(s) via a small left thoracotomy on the beating heart in patients with anterior, bi-leaflet or posterior prolapse.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Procedural Success During the First 30 Days [Procedure, discharge, and 30 days]

   To demonstrate that the Harpoon Medical Device performs as designed and can successfully implant one or more ePTFE artificial cords on either the anterior, posterior, or both leaflets of 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. Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days [Procedure, Discharge and 30 Days]

   Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded.

Secondary Outcome Measures

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

   Severity of mitral regurgitation at 6 months, 12 months and 24 months follow-up shall be tracked and recorded

2. Subject's Freedom From Serious Adverse Events Over Time [6 Months, 12 Months, and 24 Months]

   Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded

Eligibility Criteria

Criteria

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

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 cordal implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee

• Degenerative mitral valve disease associated with anterior, bileaflet, or posterior leaflet prolapse

• 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

• 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 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	Jagiellonian University	Krakow		Poland
2	Instytut of Kardiologii & Transplantology	Warsaw		Poland	04-628

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

• Principal Investigator: Krzysztof Bartus, MD PhD, Jagiellonian University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 12, 2016

More Information

Publications

None provided.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT03285724
• Other Study ID Numbers: HMEFS-2000
• First Posted: Sep 18, 2017
• Last Update Posted: Nov 19, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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: Mitral Valve Repair; Transapical; artificial chordae; bi-leaflet prolapse; anterior prolapse; posterior prolapse
• Additional relevant MeSH terms: Mitral Valve Insufficiency; Mitral Valve Prolapse; Prolapse

Study Results

Participant Flow

Arm/Group Title	Harpoon Medical Device
Arm/Group Description	Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Harpoon Medical Device
Arm/Group Description	Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
Overall Participants	1
Age, Customized (years) [Number]
Age	70
Sex: Female, Male (Count of Participants)
Female	1 100%
Male	0 0%
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	To demonstrate that the Harpoon Medical Device performs as designed and can successfully implant one or more ePTFE artificial cords on either the anterior, posterior, or both leaflets of 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.
Time Frame	Procedure, discharge, and 30 days

Outcome Measure Data

Analysis Population Description

Subject was not implanted with study Device

Arm/Group Title	Harpoon Medical Device
Arm/Group Description	Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
Measure Participants	1
Procedure	0 0%
Discharge	0 0%
30 days follow-up	0 0%

2. Primary Outcome

Title	Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days
Description	Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded.
Time Frame	Procedure, Discharge and 30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Harpoon Medical Device
Arm/Group Description	Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
Measure Participants	1
Procedure	0 0%
Discharge	0 0%
30 Days	0 0%

3. Secondary Outcome

Title	Subject's Severity of Mitral Regurgitation Over Time
Description	Severity of mitral regurgitation at 6 months, 12 months and 24 months follow-up shall be tracked and recorded
Time Frame	6 Months, 12 Months, and 24 Months

Outcome Measure Data

Analysis Population Description

Participant did not receive the Harpoon Medical Device.

Arm/Group Title	Harpoon Medical Device
Arm/Group Description	Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
Measure Participants	0

4. Secondary Outcome

Title	Subject's Freedom From Serious Adverse Events Over Time
Description	Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded
Time Frame	6 Months, 12 Months, and 24 Months

Outcome Measure Data

Analysis Population Description

Participant did not receive the Harpoon Medical Device.

Arm/Group Title	Harpoon Medical Device
Arm/Group Description	Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
Measure Participants	0

Adverse Events

Time Frame	Events occurring from baseline through end of procedure.
Adverse Event Reporting Description	Participant did not receive the Harpoon Medical Device.
Arm/Group Title	Harpoon Medical Device
Arm/Group Description	Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
All Cause Mortality
	Harpoon Medical Device
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Serious Adverse Events
	Harpoon Medical Device
	Affected / at Risk (%)	# Events
Total	1/1 (100%)
Cardiac disorders
Implantation cord failure, mitral ring damage	1/1 (100%)	1
Other (Not Including Serious) Adverse Events
	Harpoon Medical Device
	Affected / at Risk (%)	# Events
Total	0/1 (0%)

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.