Valvuloplasty Scoring Balloon Catheter First-in-Man Study
|ClinicalTrials.gov Identifier: NCT01514994|
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : April 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Stenosis||Device: AngioScore's Valvuloplasty Scoring Balloon||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Critical Aortic Valve Stenosis Using a Novel Valvuloplasty Scoring Balloon Catheter: a First-in-Man Study|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||September 2015|
|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.
- Procedural Success [ Time Frame: 1 day ]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 ]Freedom from in-hospital death, stroke, myocardial infarction or emergency cardiac surgery
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514994
|Canada, British Columbia|
|St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z1Y6|
|Principal Investigator:||John G. Webb, MD||St. Paul's Hospital, Vancouver, Canada|