Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study

NCT01213615 | Completed

• 1 other identifier: Rev B February 4, 2010
• Study Type: observational
• Target: 179
• Locations: 4 countries
• Sites: 5

Brief Summary

Since the first implant in September 1982, the Medtronic Hancock® II has provided more than 20 years of excellent hemodynamic performance and durability. Design improvements over the past generations include: low profile, flexible stent, Supra-X™ supra-annular placement, T6 anti-calcification tissue treatment, modified fixation process, CINCH® advanced implant system and ULTRA™ minimized sewing ring. Valve sizing is a critical consideration in obtaining optimal hemodynamic performance. This is particular true in small aortic roots. A critical issue is the size of the prosthesis in relation to the patient's annulus. The objective of this clinical study is to evaluate, at six and twelve months, the hemodynamic performance of the HancockÒ Ultra™ bioprosthesis in the aortic position, to analyze the incidence of patient prosthesis mismatch, correlation of gradients, and to ascertain frequency at which a larger valve size is used vs. a patient's debrided annulus diameter.

Conditions

Aortic Heart Valve Diseases

Outcome Measures

Primary Outcomes (1)

• The primary objective of the study is the hemodynamic performance of the bioprosthesis at 6 and 12 months after surgery.

  This will be measured by comparing the mean aortic valve gradients pre- and post-surgery.Left ventricular mass regression will be compared pre operative and at 6 months follow-up. The follow-up data at 12 months will be used to see if there was any improvement with the 6 months follow-up visit. .

  6 and 12 months after surgery

Secondary Outcomes (1)

• The secondary objective of the study is the incidence of patient prosthesis mismatch (PPM).

  5 to 15 days post procedure

Study Arms (1)

all patients eligible for implantation of a Hancock II Ultra

Device: Valve replacement

Interventions

Valve replacement DEVICE

Aortic valve replacement of Hancock II Ultra porcine bioprosthesis

all patients eligible for implantation of a Hancock II Ultra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient population includes all patients who require aortic valve replacement for heart valve disease (acquired or congenital) and who are candidates for a bioprosthetic valve. Patients will be informed about the aspects of this study and will be asked to give their Informed Consent.

You may qualify if:

• Patients who require aortic valve replacement with or without coronary artery bypass grafting or surgical treatment of atrial fibrillation or mitral valve repair.
• Patients who are able to provide informed consent.

You may not qualify if:

• Concomitant procedures other than coronary artery bypass grafting, surgical treatment of atrial fibrillation or mitral valve repair.
• Patients indicated for receiving a mechanical prosthesis.
• Patients who will have a replacement of existing valve prosthesis.
• Patients refusing or not able to provide informed consent.
• Patients requiring emergency surgery.
• Patients unable to participate in follow-up

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (5)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Azienda Ospedaliera Sant'Anna e San Sebastiano

Caserta, 81100, Italy

Location

Azienda Universitaria S. Maria della Misericordia

Udine, 33100, Italy

Location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

The Cardiothoracic Centre Liverpool NHS Trust

Liverpool, L14 3PE, United Kingdom

Location

MeSH Terms

Interventions

Transcatheter Aortic Valve Replacement

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: October 4, 2010
• Study Start: August 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: May 1, 2014
• Last Updated: October 30, 2015

Record last verified: 2015-10

Locations

GB (1); IT (2); BE (1); NL (1)