NCT01514994

Valvuloplasty Scoring Balloon Catheter First-in-Man Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Spectranetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	AngioScore's Valvuloplasty Scoring Balloon	All patients will receive treatment for their aortic valve stenosis with the Valvuloplasty Scoring Balloon Catheter.

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-12-01
• Completion: 2015-09-01
• First posted: 2012-01-23
• Last updated: 2016-04-18

Locations

1 site across 1 country: Canada