Hydra Single-centre Experience - Copenhagen, Denmark

Sahajanand Medical Technologies Limited50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Valve Stenosis

Interventions

Hydra Transcatheter Aortic Valve (THV) SeriesDEVICE

The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

RECRUITING

Outcomes

Primary Outcomes

Primary safety endpoint

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.

Time frame: 30 days

Primary performance endpoint

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).

Time frame: 30 days