Feasibility of a new mitral valve system delivered through the femoral vein
European Feasibility Study of High Surgical Risk Patients With Severe Mitral Regurgitation Treated With the Cardiovalve Transfemoral Mitral Valve System (AHEAD Study)
This study is testing a new mitral valve system delivered through a vein to see if it can safely help patients with severe mitral regurgitation who can't have traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cardiovalve Ltd. Industry-sponsored |
| Locations | 11 sites (Bonn, Nordrhein-Westfalen and 10 other locations) |
| Trial ID | NCT03339115 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and performance of the Cardiovalve Transfemoral Mitral Valve System in patients with severe mitral regurgitation. The device is delivered via a transfemoral access and transseptal approach, aiming to reduce mortality and adverse events in patients who are not candidates for traditional surgical options. Data will be collected on safety and performance over a 30-day period, with long-term clinical outcomes assessed over two years. The innovative design of the Cardiovalve minimizes procedural risks associated with mitral valve replacement.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with severe mitral regurgitation who are not suitable for conventional surgery.
Not a fit: Patients with mild to moderate mitral regurgitation or those who are candidates for traditional surgical interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive option for patients with severe mitral regurgitation who are at high risk for surgery.
How similar studies have performed: Other studies have shown promise with similar transcatheter approaches for mitral valve replacement, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
General Inclusion Criteria
1. Age ≥ 18 years
2. NYHA functional II, III or ambulatory IV
3. Severe mitral regurgitation (MR grade 3-4+)
4. Subject is on optimal guideline-directed medical therapy for heart failure for at least 30 days or CRT if indicated.
5. Elevated risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and imaging specialist as a minimum) based on STS/Euro Score II (per MVARC Part 1), frailty and co-morbidities.
6. Able to undergo Transesophageal Echocardiography (TEE).
7. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
8. The subject commits to return for the scheduled post-operative follow-up visits at the hospital.
Anatomical Inclusion Criteria
9. Suitable for femoral access procedure and trans septal catheterization
10. Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve (as assessed by the independent Screening Committee)
Cardiovascular Exclusion Criteria
1. Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability
2. Acute myocardial infarction within the previous 30 days
3. Any prior heart valve surgery or transcatheter mitral intervention
4. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
5. Rheumatic heart disease or endocarditis within the previous 3 months
6. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
7. Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
8. Untreated clinically significant coronary artery disease requiring revascularization
9. Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
10. Aortic or pulmonic valve disease requiring surgery
11. CRT/ICD implant within 30 days
Anatomical Exclusion Criteria (assessed by pre-procedural imaging)
12. Left Ventricular Ejection Fraction (LVEF) \<30%
13. LV end diastolic diameter \> 70mm
14. Significant abnormalities of the mitral valve and sub-valvular apparatus.
15. Severe mitral annular or leaflets calcification
16. Left atrial or LV thrombus or vegetation
17. Severe right ventricular dysfunction
18. Severe tricuspid or aortic valve disease
General Exclusion Criteria
19. Subject who is currently participating in an investigational study, other than this study
20. Hemodynamic instability defined as systolic pressure \< 90mmHg or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device, or any mechanical heart assistance
21. Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has an allergy to Nitinol alloys (nickel and titanium), or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications
22. Bleeding diathesis or hypercoagulable state
23. Active peptic ulcer or active gastrointestinal bleeding
24. Pulmonary artery systolic pressure \>70 mmHg
25. Patients with renal insufficiency (creatinine \> 2.5 mg/dL)
26. Need for emergent or urgent surgery for any reason or any planned cardiac Surgery within the next 12 months
27. Subject with hepatic insufficiency
28. Subject has a co-morbid illness that may result in a life expectancy of less than one year
29. Active infection that requires antibiotic therapy
30. Subject is pregnant, breastfeeding or intend to become pregnant within one year
Where this trial is running
Bonn, Nordrhein-Westfalen and 10 other locations
- Universitätsklinikum Bonn — Bonn, Nordrhein-Westfalen, Germany (Recruiting)
- Herzzentrum der Uniklinik Köln — Köln, Germany (Not_yet_recruiting)
- Studienzentrale der Medizinische Klinik II Universitäres Herzzentrum Lübeck — Lübeck, Germany (Recruiting)
- Universitaet_Mainz — Mainz, Germany (Not_yet_recruiting)
- Klinikum der Universität München LMU — München, Germany (Recruiting)
- Hygea — Athens, Greece (Recruiting)
- Maria Cecilia Hospital — Cotignola, Italy (Recruiting)
- Fondazione Toscana G. Monasterio-Ospedale del Cuore — Massa, Italy (Recruiting)
- San Raffaele Hospital — Milano, Italy (Recruiting)
- Policlinico San Donato — Milano, Italy (Recruiting)
- A.O.U. Pisana — Pisa, Italy (Recruiting)
Study contacts
- Study coordinator: Nitza Shoham, VP CA&A
- Email: nitza@cardiovalve.com
- Phone: +972765388142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.