Hydra Single-centre Experience - Copenhagen, Denmark
- Conditions
- Aortic Valve Stenosis
- Registration Number
- NCT06342635
- Lead Sponsor
- Sahajanand Medical Technologies Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary performance endpoint 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 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Copenhagen University Hospital, Rigshospitalet
🇩🇰Copenhagen, Denmark