Valvuloplasty Scoring Balloon Catheter First-in-Man Study
This study is currently recruiting participants.
Verified April 2013 by AngioScore, Inc.
Sponsor:
AngioScore, Inc.
Information provided by (Responsible Party):
AngioScore, Inc.
ClinicalTrials.gov Identifier:
NCT01514994
First received: January 11, 2012
Last updated: April 5, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Aortic Valve Stenosis |
Device: AngioScore's Valvuloplasty Scoring Balloon |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Critical Aortic Valve Stenosis Using a Novel Valvuloplasty Scoring Balloon Catheter: a First-in-Man Study |
Resource links provided by NLM:
Further study details as provided by AngioScore, Inc.:
Primary Outcome Measures:
- Procedural Success [ Time Frame: 1 day ] [ Designated as safety issue: No ]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. [ Time Frame: Participants will be followed for the duration of the hospital stay, an expected average of 48 hours ] [ Designated as safety issue: Yes ]Freedom from in-hospital death, stroke, myocardial infarction or emergency cardiac surgery
| Estimated Enrollment: | 35 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AngioScore's Valvuloplasty Scoring Balloon |
Device: AngioScore's Valvuloplasty Scoring Balloon
All patients will receive treatment for their aortic valve stenosis with the Valvuloplasty Scoring Balloon Catheter.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514994
Contacts
| Contact: Gary Gershony, MD | 510-933-7902 | gary@angioscore.com |
| Contact: Lisa Henry, RN | 510-933-7934 | lhenry@angioscore.com |
Locations
| Canada, British Columbia | |
| St. Paul's Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V6Z1Y6 | |
| Contact: John G. Webb, MD 604-682-2344 ext 62529 | |
| Principal Investigator: John G. Webb, MD | |
Sponsors and Collaborators
AngioScore, Inc.
Investigators
| Principal Investigator: | John G. Webb, MD | St. Paul's Hospital, Vancouver, Canada |
More Information
No publications provided
| Responsible Party: | AngioScore, Inc. |
| ClinicalTrials.gov Identifier: | NCT01514994 History of Changes |
| Other Study ID Numbers: | ST-1486 |
| Study First Received: | January 11, 2012 |
| Last Updated: | April 5, 2013 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Aortic Valve Stenosis Constriction, Pathologic Heart Valve Diseases Heart Diseases |
Cardiovascular Diseases Ventricular Outflow Obstruction Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on June 18, 2013