Aortic Valve DiseaseNCT00619151

CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics

A study testing Top Hat and Regent in people with Aortic Valve Disease, run by Sorin Group USA, Inc. at 2 sites in United States.

Terminated

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

Official record

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Trial summary

The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Valve Disease
What is being tested?: Top Hat and Regent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 2 sitesUnited States
Study dates: Dec 2007to May 2008
Phase: Interventional
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

Who may be able to join

Patients who are indicated for implant with a mechanical valve prosthesis in the aortic position according to the current practice for valve selection at the center.

Who cannot join

Patients < 18 years of age
Emergency surgery
Pre-existing valve prosthesis
Aortic root replacement
Active endocarditis

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Johns Hopkins Hospital
Baltimore, Maryland, 21287
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660

Other trials in United States

About this study

Official title: A Randomized Study to Compare Sizing, Implant Techniques, & Hemodynamic Performance Between the CarboMedics Supra-annular Top Hat Valve and the St. Jude Medical Regent Valve in the Aortic Position.

The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.

Conditions: Aortic Valve Disease
Being tested: Top Hat, Regent
Keywords: aortic valve, heart valve, valve replacement, Valve disease
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.

Top HatDevice
Implant of CarboMedics Top Hat mechanical valve.
RegentDevice
Implant of the St. Jude Medical Regent mechanical valve

Study groups in NCT00619151
Study group	Role	What they receive
1	Active comparator	CarboMedics Supra-annular Top Hat Valve Receives: Device: Top Hat
2	Active comparator	St. Jude Medical Regent Valve Receives: Device: Regent

What is being measured

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

Effective Orifice Area (EOA)
Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.
Measured: 6 month evaluation
Aortic Mean Gradient
Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.
Measured: 6 months

Timeline

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

Dec 2007May 2008

First posted20 Feb 2008 (estimated)
Study startDec 2007
Primary completionMay 2008
Study completionMay 2008

Why it stopped: Study stopped due to lack of elegible patient enrollment

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.
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: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00619151
Sponsor's protocol ID: RVSS-1H
Status last verified: Sep 2011
First submitted: 10 Jan 2008
Last updated: 16 Nov 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
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Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Valve Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Study to Compare Sizing, Implant Techniques, & Hemodynamic Performance Between the CarboMedics Supra-annular Top Hat Valve and the St. Jude Medical Regent Valve in the Aortic Position.
ClinicalTrials.gov ID: NCT00619151
Acronym / sponsor ID: RVSS-1H
Conditions: Aortic Valve Disease
Keywords: aortic valve, heart valve, valve replacement, Valve disease
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study stopped due to lack of elegible patient enrollment
Enrolment: 2 participants (actual)
Lead sponsor: Sorin Group USA, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 20 Feb 2008 (estimated)
Results: Posted 3 Nov 2011

Clinical summary

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

The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Device: Top HatCarboMedics Supra-annular Top Hat Valve
2	Active comparator	Device: RegentSt. Jude Medical Regent Valve

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients who are indicated for implant with a mechanical valve prosthesis in the aortic position according to the current practice for valve selection at the center.

Key exclusion criteria (5 listed)

Patients < 18 years of age
Emergency surgery
Pre-existing valve prosthesis
Aortic root replacement
Active endocarditis

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
Top HatImplant of CarboMedics Top Hat mechanical valve.	Device	1
RegentImplant of the St. Jude Medical Regent mechanical valve	Device	2

Primary outcome

Effective Orifice Area (EOA)
Time frame: 6 month evaluation
Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.
Aortic Mean Gradient
Time frame: 6 months
Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.

Results and safety

Results posted to the registry on 3 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Top Hat Valve	2	1
St.Jude Valve	0	0

Primary outcome: Effective Orifice Area (EOA)

Time frame: 6 month evaluation. Mean (Standard Deviation). Unit: cm^2

Population analysed: Analysis not performed due to study termination prior to analysis period.

Primary outcome: Aortic Mean Gradient

Time frame: 6 months. Mean (Standard Deviation). Unit: mmHg

Population analysed: Analysis not performed due to study termination prior to analysis period.

Adverse events

Time frame: Duration of hospital stay after surgery, an average of 4 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Top Hat Valve	0 of 2 (0%)	0 of 2 (0%)	Not reported
St.Jude Valve	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Early termination due to low enrollment resulted in only 2 patients. Insufficient data for analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Aortic Valve Disease

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Top Hat and Regent in people with Aortic Valve Disease, run by Sorin Group USA, Inc. at 2 sites in United States.

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 1 inclusion and 5 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 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 3 Nov 2011). 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?

Effective Orifice Area (EOA) (time frame: 6 month evaluation). The study lists 2 primary outcomes in all. 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 NCT00619151.

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 16 Nov 2011.