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Mini-invasive Balloon Aortic Valvuloplasty

NCT03087552 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 361

Last updated 2021-04-29

No results posted yet for this study

Summary

The spreading of transcatheter aortic valve implantation has paradoxically increased the spectrum of indications for balloon aortic valvuloplasty. Balloon aortic valvuloplasty is currently used as destination therapy for patients excluded from transcatheter aortic valve implantation, as bridge to transcatheter aortic valve implantation or to surgical aortic valve replacement, or as a stratification tool for selected high-risk patients who cannot be immediate candidates for transcatheter aortic valve implantation. Moreover, it has been recently showed that transcatheter aortic valve implantation without balloon aortic valvuloplasty is encumbered by an increased risk of cerebral embolization. However, balloon aortic valvuloplasty has a complication rate comparable to transcatheter aortic valve implantation, mainly related to access site or temporary pacemaker implantation. Thus, a transradial mini-invasive approach with rapid pacing through the 0,035 inch left ventricular support wire could be extremely appealing.

Conditions

  • Aortic Valve Stenosis

Interventions

PROCEDURE

Transradial balloon aortic valvuloplasty

Mini-invasive balloon aortic valvuloplasty consisting in transradial access

PROCEDURE

Transradial balloon aortic valvuloplasty

Rapid pacing using the 0.035-in. retrograde left ventricular support wire

Sponsors & Collaborators

  • University Hospital of Ferrara

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-11
Primary Completion
2020-01-07
Completion
2021-04-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03087552 on ClinicalTrials.gov