Hydra Single-centre Experience - Copenhagen, Denmark

Aortic Valve Stenosis Clinical Trial

Official title:

Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06342635
• Other study ID #: HYD/DENMARK-001/2023
• Status: Recruiting
• Start date: June 18, 2024
• Est. completion date: October 31, 2026

Study information

• Verified date: May 2024
• Source: Sahajanand Medical Technologies Limited
• Contact: Dr. Ole De Backer
• Phone: +4527605009
• Email: ole.debacker[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 31, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Hydra Transcatheter Aortic Valve (THV) Series
The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Sahajanand Medical Technologies Limited	Qmed Consulting A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days
Primary	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).	30 days
Secondary	Technical success		Immediately after procedure
Secondary	Cardiovascular mortality		30 days, and 1-year
Secondary	All-cause mortality		30 days, and 1-year
Secondary	All stroke		30 days, and 1-year
Secondary	Disabling stroke		30 days, and 1-year
Secondary	Myocardial infarction		30 days, and 1-year
Secondary	Major vascular complication		30 days
Secondary	Acute kidney injury		30 days
Secondary	New permanent pacemaker implantation due to procedure related conduction abnormalities		30 days, and 1-year
Secondary	New-onset atrial fibrillation		30 days, and 1-year
Secondary	Coronary artery obstruction requiring intervention		30 days, and 1-year
Secondary	Re-hospitalization for procedure- or valve-related causes		30 days, and 1-year
Secondary	Mean aortic valve gradient		30 days, and 1-year
Secondary	Effective Orifice Area (EOA)		30 days, and 1-year
Secondary	Paravalvular leak		30 days, and 1-year
Secondary	New York Heart Association (NYHA) functional class		30 days, and 1-year
Secondary	Quality-of-life evaluation		30 days, and 1-year
Secondary	Bioprosthetic Valve Failure (BVF)		30 days, and 1-year
Secondary	Bioprosthetic valve dysfunction (BVD)		30 days, and 1-year
Secondary	Stroke or peripheral embolism		30 days, and 1-year
Secondary	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
Secondary	Rates of Hypoattenuated Leaflet Thickening (HALT)		30 days
Secondary	Rates of Reduced leaflet motion (RLM)		30 days
Secondary	Commissural alignment		30 days