Health TrialsbyHealthPanel

Hydra Registry - Italy Experience

ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorSahajanand Medical Technologies Limited

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Ability to understand and provide informed consent for inclusion in the study

Disqualifiers

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

Trial population

Patient with severe aortic valve stenosis

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Hydra Transcatheter Aortic Valve System

    Device

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Cardiovascular mortality

Time frame
30 days

Secondary outcomes

1

All-cause mortality

Cardiovascular mortality, valve-related mortality, and non-cardiovascular mortality

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

All stroke

Disabling and non-disabling stroke

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

Disabling stroke

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

Myocardial infarction

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sahajanand Medical Technologies Limited

Lead sponsor

Clinica Di Montevergine

Collaborator

Source ClinicalTrials.gov
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