N/A Completed N=26 Treatment

CE Mark Study for the Harpoon Medical Device

Mitral Valve Regurgitation · Mitral valve prolapse · Mitral Valve Insufficiency

Source: ClinicalTrials.gov NCT02768870 ↗

Enrolled (actual)

Serious AEs

73.1%

Results posted

Nov 2019

Primary outcomePrimary: Subject's Procedural Success During the First 30 Days — 23 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Subject's Procedural Success During the First 30 Days	23	—
PRIMARY Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days	92.3; 57.7	—
PRIMARY Subject's Serious Adverse Events (SAE) Through Discharge	6	—
SECONDARY Subject's Severity of Mitral Regurgitation Over Time	9; 3; 6; 2; 3; 3	—
SECONDARY Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days	46.2; 38.5; 38.5; 38.5; 38.5; 38.5	—

Eligibility 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 70 mmHg)
Previous cardiac surgery, or surgery on the left pleural space
Left ventricular, atrial or appendage thrombus
Severely calcified mitral leaflets
Recent stroke ( 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02768870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.