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Dedicated Sheath Feasibility Study (BAV)

V

Valve Medical

Status

Unknown

Conditions

Aortic Stenosis

Treatments

Device: Valve Medical Dedicated Sheath version 00

Study type

Interventional

Funder types

Industry

Identifiers

NCT02617524
CLICL 01446

Details and patient eligibility

About

Dedicated Sheath feasibility study: A prospective, open-label study to evaluate the feasibility and safety of the Valve Medical Dedicated Sheath during Balloon Aortic Valvuloplasty (BAV).

Full description

This is an open-label, prospective, single arm clinical study. Up to 15 patients undergoing valvular intervention will be enrolled. Follow up will take place at 1, 6 and 24 hours post procedure. No follow up visits are required.

During the study, the patient will undergo the following tests:

  • Physical examination (includes blood pressure, age, height, weight).
  • Echo assessments prior to procedure.
  • Hemodynamic study prior and post BAV.
  • Full blood count
  • Angiography

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years.
  • Patient understands the implications of participating in the study and provides written informed consent.
  • The patient has an indication for balloon aortic valvuloplasty (BAV).

Exclusion criteria

  • Peripheral vessel anatomy or peripheral vascular disease that would preclude the insertion of the 12 Fr. sheath.
  • Any illness or condition which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Valve Medical Dedicated Sheath
Experimental group
Description:
Valve Medical Dedicated Sheath version 00
Treatment:
Device: Valve Medical Dedicated Sheath version 00

Trial contacts and locations

1

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Central trial contact

Mor Buchshtav, M.Sc.

Data sourced from clinicaltrials.gov

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