Completed

NCT Number: NCT01213615

Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study

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.

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Key information

Conditions

Aortic Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques Universitaires Saint-Luc, Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Valve replacement

Device

Aortic valve replacement of Hancock II Ultra porcine bioprosthesis

Primary outcomes

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

Time frame: 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. .

Secondary outcomes

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

Time frame: 5 to 15 days post procedure

This is measured by collecting valve sizing data during implant and the ultimate valve sizes used for implant

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2014
First posted: Oct 4, 2010
Registry last updated: Oct 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.