Aortic Heart Valve DiseasesNCT01213615
Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study
An observational study of Aortic Heart Valve Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Heart Valve Diseases
- What is being tested?
- Valve replacement
- Type of treatment
- Medical device
- How many people
- 179 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Aug 2008to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Italy2 sites
Azienda Ospedaliera Sant'Anna e San Sebastiano
Caserta, 81100
Azienda Universitaria S. Maria della Misericordia
Udine, 33100
United Kingdom1 site
The Cardiothoracic Centre Liverpool NHS Trust
Liverpool, L14 3PE
About this 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.
- Conditions
- Aortic Heart Valve Diseases
- Being tested
- Valve replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valve replacementDevice
Aortic valve replacement of Hancock II Ultra porcine bioprosthesis
| Study group | Role | What they receive |
|---|---|---|
| all patients eligible for implantation of a Hancock II Ultra | Not described Receives: Device: Valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. .
Measured: 6 and 12 months after surgery
Secondary outcomes (1)
The secondary objective of the study is the incidence of patient prosthesis mismatch (PPM).
This is measured by collecting valve sizing data during implant and the ultimate valve sizes used for implant
Measured: 5 to 15 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startAug 2008
- Primary completionOct 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213615
- Sponsor's protocol ID
- Rev B February 4, 2010
- Status last verified
- Oct 2015
- First submitted
- 26 Jul 2010
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study
- ClinicalTrials.gov ID
- NCT01213615
- Acronym / sponsor ID
- Rev B February 4, 2010
- Conditions
- Aortic Heart Valve Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Oct 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients eligible for implantation of a Hancock II Ultra | – | Device: Valve replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valve replacementAortic valve replacement of Hancock II Ultra porcine bioprosthesis | Device | all patients eligible for implantation of a Hancock II Ultra |
Primary outcome
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. .
1 secondary outcome
The secondary objective of the study is the incidence of patient prosthesis mismatch (PPM).
Time frame: 5 to 15 days post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Heart Valve Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Belgium, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2015.