Trial Search Results

CE Mark Study for the Harpoon Medical Device

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Edwards Lifesciences

Stanford Investigator(s):

Intervention(s):

  • Device: Harpoon Artificial ePTFE Chords

Phase:

N/A

Eligibility


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 < 18 years

   - Infective endocarditis

   - Anterior or bileaflet prolapse

   - Functional MR

   - 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 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting