Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis

ConditionLow Flow, Low Gradient Aortic Stenosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of Salerno

About this trial

LOW-TAVR is a real-world, retrospective and prospective, multicenter Italian registry aimed at evaluating the characteristics and clinical outcomes of patients with severe low flow, low gradient aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) and, in particular:

* risk factors * gender differences * comorbidities * pharmacological treatment * TAVR procedural characteristics * periprocedural and in-hospital complications * clinical outcome at 30-day, 1-year, 2-year and 5-year follow-up

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

LFLG-AS diagnosis according to current European Society of Cardiology guidelines

Age 18 years or older

Written informed consent

Disqualifiers

LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis

LFLG-AS referred for medical treatment or undergoing surgery

Trial population

Patients with severe low flow, low gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Transcatheter aortic valve replacement
Device
Transcatheter aortic valve replacement with implantation of new-generation balloon-expandable or self-expandable bioprostheses

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

Composite of all-cause death and hospitalization for worsening heart failure

Death due to cardiac or non-cardiac cause and new hospitalization for worsening heart failure

Time frame

1 year

Sponsors and contacts

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

University of Salerno

Lead sponsor

Source ClinicalTrials.gov

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