Clinical trial NCT06342635: Hydra Single-centre Experience - Copenhagen, Denmark
Official title: Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Keywords: Aortic Valve Stenosis
TAVI
Hydra
Lead sponsor: Sahajanand Medical Technologies Limited
Sponsor class: INDUSTRY
Collaborators: name: Qmed Consulting A/S
First posted: 2024-04-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with severe aortic valve stenosis

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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Patients affected by severe aortic stenosis (NYHA class ≥ II) eligible for TAVI procedure as per local Heart Team evaluation
3. Full understanding and willing to provide informed consent to study enrolment

Exclusion Criteria:

1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
2. Refusal to provide informed consent to study enrolment
3. Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI
4. 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

Primary outcomes:
measure: Primary safety endpoint
timeFrame: 30 days
measure: Primary performance endpoint
timeFrame: 30 days
Secondary outcomes:
measure: Technical success
timeFrame: Immediately after procedure
measure: Cardiovascular mortality
timeFrame: 30 days, and 1-year
measure: All-cause mortality
timeFrame: 30 days, and 1-year
measure: All stroke
timeFrame: 30 days, and 1-year
measure: Disabling stroke
timeFrame: 30 days, and 1-year
measure: Myocardial infarction
timeFrame: 30 days, and 1-year
measure: Major vascular complication
timeFrame: 30 days
measure: Acute kidney injury
timeFrame: 30 days
measure: New permanent pacemaker implantation due to procedure related conduction abnormalities
timeFrame: 30 days, and 1-year
measure: New-onset atrial fibrillation
timeFrame: 30 days, and 1-year
measure: Coronary artery obstruction requiring intervention
timeFrame: 30 days, and 1-year
measure: Re-hospitalization for procedure- or valve-related causes
timeFrame: 30 days, and 1-year
measure: Mean aortic valve gradient
timeFrame: 30 days, and 1-year
measure: Effective Orifice Area (EOA)
timeFrame: 30 days, and 1-year
measure: Paravalvular leak
timeFrame: 30 days, and 1-year
measure: New York Heart Association (NYHA) functional class
timeFrame: 30 days, and 1-year
measure: Quality-of-life evaluation
timeFrame: 30 days, and 1-year
measure: Bioprosthetic Valve Failure (BVF)
timeFrame: 30 days, and 1-year
measure: Bioprosthetic valve dysfunction (BVD)
timeFrame: 30 days, and 1-year
measure: Stroke or peripheral embolism
timeFrame: 30 days, and 1-year
measure: VARC-3 Type 3-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns
timeFrame: 30 days, and 1-year
measure: Rates of Hypoattenuated Leaflet Thickening (HALT)
timeFrame: 30 days
measure: Rates of Reduced leaflet motion (RLM)
timeFrame: 30 days
measure: Commissural alignment
timeFrame: 30 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
Study officials:
References: