Valvuloplasty Scoring Balloon Catheter First-in-Man Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by AngioScore, Inc.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Pathological Conditions, Anatomical
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on October 28, 2014