Hydra Single-centre Experience - Copenhagen, Denmark

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

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 Overview

• Status: Not yet recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Hydra Transcatheter Aortic Valve (THV) Series

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Dr. Ole De Backer; Phone Number: +4527605009; Email: ole.debacker@gmail.com

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Copenhagen University Hospital, Rigshospitalet
    • Contact: Dr. Ole De Backer
    • Principal Investigator: Dr. Ole De Backer, Copenhagen University Hospital, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with severe aortic valve stenosis

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sahajanand Medical Technologies Limited
• Collaborators: Qmed Consulting A/S

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Aortic Valve Stenosis; TAVI; Hydra
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: HYD/DENMARK-001/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No