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Valvuloplasty Scoring Balloon Catheter First-in-Man Study

Primary Purpose

Aortic Valve Stenosis

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

AngioScore's Valvuloplasty Scoring Balloon

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Native, degenerative-calcific, tricuspid, aortic valve stenosis with echocardiographic derived criteria: mean gradient of >40 mm Hg or Doppler peak systolic velocity greater than 4.0 m/s or an initial aortic valve area < 0.8 cm2.
Symptomatic aortic valve disease as demonstrated by CCS Functional Class II or greater
Aortic valve annulus of greater than or equal to 18 mm and less than or equal to 28 mm measured on pre-procedure TTE.
Phase 1 patients must be scheduled for a surgical aortic valve replacement.
Phase 2 patients must not be suitable candidates for elective surgical aortic valve replacement.

Exclusion Criteria:

Recent myocardial infarction (<30days)
Unicuspid or bicuspid aortic valve or non-calcific aortic valve stenosis
Any sepsis, including active endocarditis
Concomitant 2+ or greater aortic valve valve regurgitation
LVEF < 20%
CVA or TIA within the previous 6 months
Previous aortic valve replacement (bioprosthetic or mechanical)

Sites / Locations

St. Paul's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AngioScore's Valvuloplasty Scoring Balloon

Arm Description

Outcomes

Primary Outcome Measures

Procedural Success

Procedural success defined as a >50% increase in the aortic valve effective orifice area and less than or equal to 2+ valvular regurgitation at the end of the percutaneous valvuloplasty procedure utilizing echocardiography, hemodynamic measurements and angiography.

Number of participants who do not experience death, stroke, myocardial infarction or emergency cardiac surgery during their hospitalization.

Freedom from in-hospital death, stroke, myocardial infarction or emergency cardiac surgery

Secondary Outcome Measures

Full Information

NCT ID

NCT01514994

First Posted

January 11, 2012

Last Updated

April 15, 2016

Sponsor

Spectranetics Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01514994

Brief Title

Valvuloplasty Scoring Balloon Catheter First-in-Man Study

Official Title

Treatment of Critical Aortic Valve Stenosis Using a Novel Valvuloplasty Scoring Balloon Catheter: a First-in-Man Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Spectranetics Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring Balloon Catheter for the treatment of critical aortic valve stenosis.

Detailed Description

Phase 1 will enroll patient who are scheduled to undergo open surgical aortic valve replacement and will have the Valvuloplasty Scoring Balloon delivered to their stenotic aortic valve through a standard aortotomy and deployed immediately prior to valve replacement. Phase 2 will enroll patients with aortic valve stenosis who are deemed to not be suitable candidates for elective surgical aortic valve replacement and in whom the investigational Valvuloplasty Scoring Balloon will be used as a stand-alone Valvuloplasty procedure or "bridge" to trans-catheter aortic valve implantation (TAVI) or surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AngioScore's Valvuloplasty Scoring Balloon

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

AngioScore's Valvuloplasty Scoring Balloon

Intervention Description

All patients will receive treatment for their aortic valve stenosis with the Valvuloplasty Scoring Balloon Catheter.

Primary Outcome Measure Information:

Title

Procedural Success

Description

Time Frame

1 day

Title

Number of participants who do not experience death, stroke, myocardial infarction or emergency cardiac surgery during their hospitalization.

Description

Freedom from in-hospital death, stroke, myocardial infarction or emergency cardiac surgery

Time Frame

Participants will be followed for the duration of the hospital stay, an expected average of 48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Native, degenerative-calcific, tricuspid, aortic valve stenosis with echocardiographic derived criteria: mean gradient of >40 mm Hg or Doppler peak systolic velocity greater than 4.0 m/s or an initial aortic valve area < 0.8 cm2. Symptomatic aortic valve disease as demonstrated by CCS Functional Class II or greater Aortic valve annulus of greater than or equal to 18 mm and less than or equal to 28 mm measured on pre-procedure TTE. Phase 1 patients must be scheduled for a surgical aortic valve replacement. Phase 2 patients must not be suitable candidates for elective surgical aortic valve replacement. Exclusion Criteria: Recent myocardial infarction (<30days) Unicuspid or bicuspid aortic valve or non-calcific aortic valve stenosis Any sepsis, including active endocarditis Concomitant 2+ or greater aortic valve valve regurgitation LVEF < 20% CVA or TIA within the previous 6 months Previous aortic valve replacement (bioprosthetic or mechanical)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John G. Webb, MD

Organizational Affiliation

St. Paul's Hospital, Vancouver, Canada

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Paul's Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z1Y6

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Valvuloplasty Scoring Balloon Catheter First-in-Man Study

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