NCT06342635

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
18mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Jun 2024Oct 2027

First Submitted

Initial submission to the registry

March 21, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

June 18, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

March 21, 2024

Last Update Submit

April 22, 2026

Conditions

Aortic Valve Stenosis

Keywords

Aortic Valve StenosisTAVIHydra

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (24)

  • 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

  • +19 more secondary outcomes

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 Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with severe aortic valve stenosis

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Central Study Contacts

Dr. Ole De Backer

CONTACT

+4527605009ole.debacker@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2024

First Posted

April 2, 2024

Study Start

June 18, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations

DK(1)