Transfemoral Implant of Inovare® Transcatheter Valve - Clinical Trial of Feasibility and Safety and Efficacy Verification
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Device success
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Clinical trial to evaluate the early safety and efficacy of the transfemoral implant of Inovare® Transcatheter Valve for the treatment of patients with severe degenerative aortic stenosis and high surgical risk.
Detailed Description
The Inovare® transcatheter valve was developed and has been market ed since 2011 for replacement, via transapical or transaortic route, of calcified native aortic valves and degenerated bioprostheses (aortic and mitral) with satisfactory medium-long-term results. The present study aims to evaluate the safety and clinical performance of the new navigation and delivery system of this device using the transfemoral route. The new device has as its main feature the drivable control of the curvature of the delivery system, the which allows better navigability in regions of more complex anatomy, especially with accentuated tortuosities.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Calcified degenerative aortic stenosis with valve area \< 1.0 cm2 (or valve area index \< 0.6 cm2/m2) and mean transvalvular gradient \> 40 mmHg or aortic jet velocity \> 4 m/s by echocardiogram.
- •Multidisciplinary evaluation by the "Heart Team", composed of a cardiovascular surgeon, clinical cardiologist and hemodynamicist, which concludes that the patient has:
- •High surgical risk for aortic valve replacement, typically with an STS score of ≥ 8% (or logistic EuroSCORE ≥ 20%) or intermediate risk (STS of ≥ 3% and \< 8%);
- •Presence of porcelain aorta or hostile chest, as well as global clinical condition and comorbidities not fully addressed by the score STS
- •Presence of extreme frailty (5-meter walk test \[5MWT\], grip strength, activities of daily living (ADL), and albumin laboratory exam);
- •Considerable chance of clinical benefit with the transcatheter procedure.
- •Heart failure symptoms NYHA functional ≥ II.
- •Aortic valve annulus with a mean diameter between 17.3 and 28.6 mm, documented by imaging method, suitable for positioning and accommodation of the Inovare® prosthesis, according to the judgment of an experienced hemodynamicist.
- •Height of coronary ostia \> 10 mm or presence of a coronary graft that prevents the occurrence of acute myocardial ischemia due to coronary occlusion after valve release.
- •Femoral arterial access route considered adequate for the progression of the vascular introducer and prosthesis-balloon system, typically evaluated through multi-imaging methods that include, for example, conventional angiography and computed tomography.
Exclusion Criteria
- •Hemodynamic instability requiring vasoactive drugs or circulatory support;
- •Valve procedure with clinical need to be performed in a time of urgency or emergency (non-elective);
- •Left ventricular ejection fraction \< 30%;
- •Chronic renal failure on dialysis or with serum creatinine levels \> 3.0 mg/dL (265 µmol/L);
- •Acute renal failure with serum creatinine that has not yet returned to baseline levels;
- •Clinical or biological signs of infection with systemic repercussions;
- •Endocarditis \< 12 months;
- •Coronary artery disease requiring elective revascularization during or after the valve procedure;
- •Evidence of myocardial infarction in an interval of less than one month;
- •Recent stroke or transient ischemic attack (within the last 6 months);
Outcomes
Primary Outcomes
Device success
Time Frame: Procedure
Absence of mortality in the procedure AND correct positioning of a single bioprosthesis with the intended performance (mean gradient \< 20 mmHg and regurgitation ≥ moderate).
Death the first 30 days
Time Frame: 30 days
Deaths from any cause within the first 30 days of the procedure or during hospital stay will be considered procedure-related deaths.
Secondary Outcomes
- Incidence of serious adverse events(30 days or more)
- Device success(30 days or more)
- Efficacy of the procedure(30 days or more)