NCT02617524

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

November 24, 2015

Last Update Submit

January 17, 2016

Conditions

Aortic Stenosis

Keywords

dedicated sheath

Outcome Measures

Primary Outcomes (2)

  • Device success

    Outcome measures will be assessed at 1, 6 and 24 hours post procedure.

  • Procedure Safety: Adverse Event Assessment for device related and unrelated events

    Outcome measures will be assessed at enrollment, throughout the procedure and 1, 6 and 24 hours post procedure.

Study Arms (1)

Valve Medical Dedicated Sheath

EXPERIMENTAL

Valve Medical Dedicated Sheath version 00

Device: Valve Medical Dedicated Sheath version 00

Interventions

Valve Medical Dedicated Sheath version 00DEVICE

The Valve Medical Dedicated Sheath is intended to be used as an introducer sheath during BAV procedures

Valve Medical Dedicated Sheath

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Central Study Contacts

Mor Buchshtav, M.Sc.

CONTACT

972 3 7679000morb@medinol.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 1, 2015

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations

IL(1)