Hydra Single-centre Experience - Copenhagen, Denmark

April 22, 2026 updated by: Sahajanand Medical Technologies Limited

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary safety endpoint
Time Frame: 30 days

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
Time Frame: 30 days

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Technical success
Time Frame: Immediately after procedure
Immediately after procedure
Cardiovascular mortality
Time Frame: 30 days, and 1-year
30 days, and 1-year
All-cause mortality
Time Frame: 30 days, and 1-year
30 days, and 1-year
All stroke
Time Frame: 30 days, and 1-year
30 days, and 1-year
Disabling stroke
Time Frame: 30 days, and 1-year
30 days, and 1-year
Myocardial infarction
Time Frame: 30 days, and 1-year
30 days, and 1-year
Major vascular complication
Time Frame: 30 days
30 days
Acute kidney injury
Time Frame: 30 days
30 days
New permanent pacemaker implantation due to procedure related conduction abnormalities
Time Frame: 30 days, and 1-year
30 days, and 1-year
New-onset atrial fibrillation
Time Frame: 30 days, and 1-year
30 days, and 1-year
Coronary artery obstruction requiring intervention
Time Frame: 30 days, and 1-year
30 days, and 1-year
Re-hospitalization for procedure- or valve-related causes
Time Frame: 30 days, and 1-year
30 days, and 1-year
Mean aortic valve gradient
Time Frame: 30 days, and 1-year
30 days, and 1-year
Effective Orifice Area (EOA)
Time Frame: 30 days, and 1-year
30 days, and 1-year
Paravalvular leak
Time Frame: 30 days, and 1-year
30 days, and 1-year
New York Heart Association (NYHA) functional class
Time Frame: 30 days, and 1-year
30 days, and 1-year
Quality-of-life evaluation
Time Frame: 30 days, and 1-year
30 days, and 1-year
Bioprosthetic Valve Failure (BVF)
Time Frame: 30 days, and 1-year
30 days, and 1-year
Bioprosthetic valve dysfunction (BVD)
Time Frame: 30 days, and 1-year
30 days, and 1-year
Stroke or peripheral embolism
Time Frame: 30 days, and 1-year
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
Time Frame: 30 days, and 1-year
30 days, and 1-year
Rates of Hypoattenuated Leaflet Thickening (HALT)
Time Frame: 30 days
30 days
Rates of Reduced leaflet motion (RLM)
Time Frame: 30 days
30 days
Commissural alignment
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sahajanand Medical Technologies Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Qmed Consulting A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings