Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Sahajanand Medical Technologies Limited
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Primary performance endpoint
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •Patients affected by severe aortic stenosis (NYHA class ≥ II) eligible for TAVI procedure as per local Heart Team evaluation
- •Full understanding and willing to provide informed consent to study enrolment
Exclusion Criteria
- •Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
- •Refusal to provide informed consent to study enrolment
- •Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI
- •Patients with calcification on the annulus and in the Left Ventricular Outflow Tract (LVOT), or/and excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator
Outcomes
Primary Outcomes
Primary performance endpoint
Time Frame: 30 days
Device success as defined by VARC-3, as composite of: * Technical success; * Freedom from mortality; * Freedom from surgery or intervention related to the device or to a major vascular or access related or cardiac structural complication; * Intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).
Primary safety endpoint
Time Frame: 30 days
Early safety as defined by VARC-3, as composite of: * Freedom from all-cause mortality; * Freedom from all stroke; * Freedom from VARC 3 type 3-4 bleeding; * Freedom from major vascular, access-related, or cardiac structural complication; * Freedom from acute kidney injury stage 3 or 4; * Freedom from moderate or severe aortic regurgitation; * Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; * Freedom from surgery or intervention related to the device.
Secondary Outcomes
- Disabling stroke(30 days, and 1-year)
- Major vascular complication(30 days)
- New permanent pacemaker implantation due to procedure related conduction abnormalities(30 days, and 1-year)
- Effective Orifice Area (EOA)(30 days, and 1-year)
- All-cause mortality(30 days, and 1-year)
- All stroke(30 days, and 1-year)
- Acute kidney injury(30 days)
- Myocardial infarction(30 days, and 1-year)
- Coronary artery obstruction requiring intervention(30 days, and 1-year)
- Mean aortic valve gradient(30 days, and 1-year)
- Technical success(Immediately after procedure)
- Cardiovascular mortality(30 days, and 1-year)
- Quality-of-life evaluation(30 days, and 1-year)
- Bioprosthetic valve dysfunction (BVD)(30 days, and 1-year)
- New-onset atrial fibrillation(30 days, and 1-year)
- Re-hospitalization for procedure- or valve-related causes(30 days, and 1-year)
- New York Heart Association (NYHA) functional class(30 days, and 1-year)
- Stroke or peripheral embolism(30 days, and 1-year)
- VARC-3 Type 3-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns(30 days, and 1-year)
- Commissural alignment(30 days)
- Paravalvular leak(30 days, and 1-year)
- Rates of Hypoattenuated Leaflet Thickening (HALT)(30 days)
- Bioprosthetic Valve Failure (BVF)(30 days, and 1-year)
- Rates of Reduced leaflet motion (RLM)(30 days)