Aortic Valve DiseaseNCT01256710

Trifecta™ Durability Study

An observational study of Aortic Valve Disease, run by Abbott Medical Devices at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Valve Disease
What is being tested?: Trifecta™ aortic bioprosthesis
Type of treatment: Medical device
How many people: 1,151 participants
Where: 1 siteGermany
Study dates: Jan 2011to 12 Mar 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Patients that are candidates for implantation or have been implanted over the past 9 months with a Trifecta™ aortic valve.

Who may be able to join

Patients implanted for less than 9 months with a Trifecta™ valve, or patients who are candidates for implant with a Trifecta™ valve, as per current guidelines
Patient requires aortic valve replacement.
Patient is legal age in host country.
Patients must be able and willing to provide written informed consent to participate in this investigation
Patients must be willing and able to comply with all follow-up requirements

Who cannot join

Patients with contraindication for cardiac surgery
Patients who are pregnant.
Patient is unwilling to or has an inability that reduces his mobility in order to attend the required follow-up visits.
Patient has active endocarditis
Patient has had an acute preoperative neurological event defined as patient has not returned to baseline 30 days prior to the planned valve implantation surgery.
Patient is undergoing renal dialysis.

Show all 14Show fewer

Patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate.
Patient has a documented thrombus in left atrium or left ventricle.
Patient had in the past mitral or tricuspid valve replacement.
Patient needs mitral and/or tricuspid valve replacement.
Patient has an Ejection Fraction < 25%
Patient had the Trifecta™ valve implanted as part of this study, but then had the device explanted
Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
Patient has a life expectancy less than two years.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Universitat Herzzentrum Leipzig
Leipzig, 04289

Other trials in Germany

About this study

The Trifecta™ Durability Study was a multi-center, prospective, single-arm, post-market study conducted in Europe and Canada to collect long-term safety and performance data on the Trifecta™ valve. The Trifecta™ valve is a stented surgical aortic bioprosthesis with bovine pericardial leaflets designed for supra annular placement.

Conditions: Aortic Valve Disease
Being tested: Trifecta™ aortic bioprosthesis
Medical subject headings: Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trifecta™ aortic bioprosthesisDevice
Surgical aortic valve replacement with the Trifecta™ valve.

Study groups in NCT01256710
Study group	Role	What they receive
Trifecta™ Valve Group		Subjects implanted with the Trifecta™ aortic bioprosthesis. Receives: Device: Trifecta™ aortic bioprosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

Actuarial Freedom From Reintervention Due to Structural Valve Deterioration
Percentage of participants free from surgical explant or valve-in-valve transcatheter aortic valve intervention for treatment of structural deterioration of the Trifecta™ valve through 10 years post-implant. This percentage is estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation.
Measured: 10 years

Secondary outcomes (3)

Actuarial Freedom From All-cause Mortality
Percentage of participants free of death from any cause through 10 years after implant with the Trifecta™ valve, estimated from time-to-event data using the Kaplan-Meier estimator.
Measured: 10 years
Freedom From Valve Related Mortality
Percentage of participants free from death related to the Trifecta™ valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Valve-related mortality includes deaths due to any of the following events involving the study valve: structural valvular deterioration, nonstructural valve dysfunction, valve thrombosis, embolism, bleeding events, endocarditis, or reoperation. Sudden, unexplained deaths of participants implanted with the Trifecta™ valve are also counted as valve-related mortality.
Measured: 10 years
Freedom From Structural Valve Deterioration
Percentage of participants free of structural deterioration of the Trifecta valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation. The presence of structural valve deterioration is determined by direct visualization of the valve at explant or autopsy or by echocardiographic or other cardiac imaging criteria for assessment of valvular stenosis and regurgitation.
Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201112 Mar 2021

First posted8 Dec 2010 (estimated)
Study startJan 2011
Primary completion12 Mar 2021
Study completion12 Mar 2021

Why it stopped: The study was terminated approximately 6 months earlier than planned because 227 subjects (59% more than anticipated) had already completed 10-Year Visits due to lower than expected subject attrition.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe 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: 1,151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01256710
Sponsor's protocol ID: CS-10-012-EU-TV
Status last verified: Feb 2023
First submitted: 7 Dec 2010
Last updated: 22 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Aortic Valve Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trifecta™ Durability Study
ClinicalTrials.gov ID: NCT01256710
Acronym / sponsor ID: CS-10-012-EU-TV
Conditions: Aortic Valve Disease
Study type: Observational
Recruitment status: TerminatedReason stopped: The study was terminated approximately 6 months earlier than planned because 227 subjects (59% more than anticipated) had already completed 10-Year Visits due to lower than expected subject attrition.
Enrolment: 1,151 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Jan 2011 (actual)
Primary completion: 12 Mar 2021 (actual)
Study completion: 12 Mar 2021 (actual)
First posted: 8 Dec 2010 (estimated)
Results: Posted 22 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Trifecta™ Valve Group	–	Device: Trifecta™ aortic bioprosthesisSubjects implanted with the Trifecta™ aortic bioprosthesis.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients that are candidates for implantation or have been implanted over the past 9 months with a Trifecta™ aortic valve.

Key inclusion criteria (5 listed)

Patients implanted for less than 9 months with a Trifecta™ valve, or patients who are candidates for implant with a Trifecta™ valve, as per current guidelines
Patient requires aortic valve replacement.
Patient is legal age in host country.
Patients must be able and willing to provide written informed consent to participate in this investigation
Patients must be willing and able to comply with all follow-up requirements

Key exclusion criteria (14 listed)

Patients with contraindication for cardiac surgery
Patients who are pregnant.
Patient is unwilling to or has an inability that reduces his mobility in order to attend the required follow-up visits.
Patient has active endocarditis
Patient has had an acute preoperative neurological event defined as patient has not returned to baseline 30 days prior to the planned valve implantation 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
Trifecta™ aortic bioprosthesisSurgical aortic valve replacement with the Trifecta™ valve.	Device	Trifecta™ Valve Group

Primary outcome

Actuarial Freedom From Reintervention Due to Structural Valve Deterioration
Time frame: 10 years
Percentage of participants free from surgical explant or valve-in-valve transcatheter aortic valve intervention for treatment of structural deterioration of the Trifecta™ valve through 10 years post-implant. This percentage is estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation.

3 secondary outcomes

Actuarial Freedom From All-cause Mortality
Time frame: 10 years
Freedom From Valve Related Mortality
Time frame: 10 years
Freedom From Structural Valve Deterioration
Time frame: 10 years

Results and safety

Results posted to the registry on 22 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trifecta™ Valve Group	1,151	227

Primary outcome: Actuarial Freedom From Reintervention Due to Structural Valve Deterioration

Time frame: 10 years. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Trifecta Valve™ Group n = 1151
Value	85.0 (81.6 to 87.8)

Population analysed: The analysis population includes participants implanted with the Trifecta™ valve who met all study eligibility criteria and consented to be enrolled in the study.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trifecta Valve Group	952 of 1,151 (82.7%)	562 of 1,151 (48.8%)	449 of 1,151

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Sven Lehmann principal investigator

Universitat Herzzentrum Leipzig

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Disease, run by Abbott Medical Devices at 1 site in Germany.

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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

Yes. Results are posted in the registry (first posted 22 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Actuarial Freedom From Reintervention Due to Structural Valve Deterioration (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01256710.

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 22 Nov 2023.