NCT05956652

Brief Summary

Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jul 2023Jul 2029

Study Start

First participant enrolled

July 1, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2029

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

July 14, 2023

Last Update Submit

April 22, 2026

Conditions

Aortic Valve Stenosis

Keywords

Aortic Valve StenosisTAVIHydra

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular mortality

    30 days

Secondary Outcomes (12)

  • All-cause mortality

    30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  • All stroke

    30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  • Disabling stroke

    30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  • Myocardial infarction

    30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  • Life-threatening or disabling bleeding

    30 days

  • +7 more secondary outcomes

Interventions

Hydra Transcatheter Aortic Valve SystemDEVICE

The Hydra device is self-expanding transcatheter aortic valve 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:

  • Patients with severe symptomatic native aortic valve stenosis and candidates for the TAVI procedure based on the evaluation of the Heart Team

You may not qualify if:

  • Contraindication to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis.
  • Refusal by the patient to participate in the study
  • High probability of non-adherence to required follow-ups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fondazione Poliambulanza Istituto

Brescia, 25124, Italy

RECRUITING

Montevergine Clinic, Mercogliano, Italy

Mercogliano, 83013, Italy

RECRUITING

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, 20157, Italy

NOT YET RECRUITING

Università degli studi di Padova

Padova, 35122, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Dr. Angelo Cioppa

    Montevergine Clinic, Mercogliano, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Angelo Cioppa

CONTACT

+390825705131emodinamica@clinicamontevergine.it

Study Design

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

Study Record Dates

First Submitted

July 14, 2023

First Posted

July 21, 2023

Study Start

July 1, 2023

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2029

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(4)