Pulmonary Valve StenosisSGPVNCT01092442

CryoValve SG Pulmonary Human Heart Valve Post Clearance Study

An observational study of Pulmonary Valve Stenosis and Pulmonary Valve Insufficiency, run by CryoLife, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve. Read more about this study

Who is it for?: Any age
Conditions the study is for: Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency, Aortic Valve Stenosis
What is being tested?: Echocardiogram
Type of treatment: Surgery or procedure
How many people: 140 participants
Where: 8 sitesUnited States
Study dates: Jan 2010to Dec 2014
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Consecutive patients who have had a CryoValve SG Pulmonary Human Heart Valve implanted in the pulmonary position for right ventricular outflow tract (RVOT) reconstruction or as part of the Ross procedure at selected institutions.

Retrospective Patients
Sequential patients implanted with a CryoValve SG Pulmonary Human Heart Halve as a Ross or RVOT reconstruction between February 2000 and March 2004 who were included in the 510(k) data collection will be identified using the following general criteria to aid in selection of patients who are most likely to provide adequate follow-up data: Patient is alive and the implanted valve is still in place (has not been explanted).

Patient is still under the care of the implanting institution or the implanting surgeon.

Patient was identified as previously providing data for at least one echocardiographic follow-up assessment at a minimum of one year post-implant.

Additionally, prospective enrolling centers will have the option to enroll retrospective patients. At these centers, all consecutive patients identified from valve implant data at CryoLife, implanted with a CryoValve SG Pulmonary Valve as a valved pulmonary valve prior to Clearance in 2008 will be targeted for inclusion in the retrospective patient data collection.
Prospective Patients
Sequential patients implanted with a CryoValve SG Pulmonary Human Heart Halve as a Ross or RVOT reconstruction after FDA 510(k) clearance in February 2008 at selected institutions.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

University of Michigan
Ann Arbor, Michigan, 48109
Cardiothoracic and Vascular Surgeons and Austin Heart
Austin, Texas, 78756
Indiana University
Indianapolis, Indiana, 46202
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
Oklahoma University Health and Sciences Center
Oklahoma City, Oklahoma, 73126
Arizona Pediatric Cardiology Consultants
Phoenix, Arizona, 85006
Methodist Healthcare System of San Antonio
San Antonio, Texas, 78229
Washington University
St Louis, Missouri, 63110

Other trials in United States

About this study

The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.

Read the detailed description

The CryoValve SG pulmonary human heart valve is recovered from deceased human donors, treated with the SynerGraft® process,which is designed to reduce the donor cells present on the graft. The valve is then cryopreserved for storage until use. Removing cells from the heart valve has been shown to reduce a component of the immune response after implant compared to a standard allograft valve. However, it is not known how this affects the long-term durability of the valve.

Conditions: Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency, Aortic Valve Stenosis, Aortic Valve Insufficiency
Being tested: Echocardiogram
Keywords: Pulmonary Valve, Right Ventricular Outflow Tract Reconstruction, Ross Procedure
Medical subject headings: Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency, Aortic Valve Stenosis, Aortic Valve Insufficiency

What participants receive

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

EchocardiogramProcedure or surgery
Patients will have a yearly echocardiogram after enrollment in the study.

Study groups in NCT01092442
Study group	Role	What they receive
Retrospective Patients		Retrospective Patients: The patient group who had the CryoValve SG Pulmonary Human Heart Valve implanted prior to the February 2008 clearance of the valve. Receives: Procedure: Echocardiogram
Prospective Patients		Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve. Receives: Procedure: Echocardiogram

What is being measured

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

Hemodynamic Performance
Peak Pulmonary Gradient Mean Pulmonary Gradient
Measured: Most Recent follow-up (average of 3-6 years post implant)
Hemodynamic Performance
Pulmonary Insufficiency Grade
Measured: Most Recent Follow-up (average of 4 to 6 years post implant)
Safety Assessment
Evaluation of the following adverse events
- Mortality (all cause and valve-related)
- Reoperation/reintervention
- Explant
- Endocarditis
- Structural valve deterioration (defined as >40 mmHg peak pulmonary gradient or >30 mmHg mean pulmonary gradient or moderately severe to severe pulmonary insufficiency)
- Thrombosis
- Thromboembolism (pulmonary embolism)
- Non-structural dysfunction
- Perivalvular leak
- Bleeding
- Hemolysis
- Calcification
Measured: Since Implant of the Valve to a Maximum of 13.0 years

Timeline

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

Jan 2010Dec 2014

First posted25 Mar 2010 (estimated)
Study startJan 2010
Primary completionDec 2014
Study completionDec 2014

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Pulmonary Valve StenosisStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01092442
Sponsor's protocol ID: CSG801.002-M
Acronym: SGPV
Status last verified: Aug 2016
First submitted: 23 Mar 2010
Last updated: 6 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Brown JW, Elkins RC, Clarke DR, Tweddell JS, Huddleston CB, Doty JR, Fehrenbacher JW, Takkenberg JJ. Performance of the CryoValve SG human decellularized pulmonary valve in 342 patients relative to the conventional CryoValve at a mean follow-up of four years. J Thorac Cardiovasc Surg. 2010 Feb;139(2):339-48. doi: 10.1016/j.jtcvs.2009.04.065.
PubMed 20106397
Konuma T, Devaney EJ, Bove EL, Gelehrter S, Hirsch JC, Tavakkol Z, Ohye RG. Performance of CryoValve SG decellularized pulmonary allografts compared with standard cryopreserved allografts. Ann Thorac Surg. 2009 Sep;88(3):849-54; discussion 554-5. doi: 10.1016/j.athoracsur.2009.06.003.
PubMed 19699910
Hawkins JA, Hillman ND, Lambert LM, Jones J, Di Russo GB, Profaizer T, Fuller TC, Minich LL, Williams RV, Shaddy RE. Immunogenicity of decellularized cryopreserved allografts in pediatric cardiac surgery: comparison with standard cryopreserved allografts. J Thorac Cardiovasc Surg. 2003 Jul;126(1):247-52; discussion 252-3. doi: 10.1016/s0022-5223(03)00116-8.
PubMed 12878962

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 Pulmonary Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CryoValve SG Pulmonary Human Heart Valve Post Clearance Study
ClinicalTrials.gov ID: NCT01092442
Acronym / sponsor ID: SGPV / CSG801.002-M
Conditions: Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency, Aortic Valve Stenosis, Aortic Valve Insufficiency
Keywords: Pulmonary Valve, Right Ventricular Outflow Tract Reconstruction, Ross Procedure
Study type: Observational
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: CryoLife, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 25 Mar 2010 (estimated)
Results: Posted 9 Dec 2015

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 collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Retrospective Patients	–	Procedure: EchocardiogramRetrospective Patients: The patient group who had the CryoValve SG Pulmonary Human Heart Valve implanted prior to the February 2008 clearance of the valve.
Prospective Patients	–	Procedure: EchocardiogramProspective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Consecutive patients who have had a CryoValve SG Pulmonary Human Heart Valve implanted in the pulmonary position for right ventricular outflow tract (RVOT) reconstruction or as part of the Ross procedure at selected institutions.

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
EchocardiogramPatients will have a yearly echocardiogram after enrollment in the study.	Procedure or surgery	Prospective Patients, Retrospective Patients

Primary outcome

Hemodynamic Performance
Time frame: Most Recent follow-up (average of 3-6 years post implant)
Peak Pulmonary Gradient Mean Pulmonary Gradient
Hemodynamic Performance
Time frame: Most Recent Follow-up (average of 4 to 6 years post implant)
Pulmonary Insufficiency Grade
Safety Assessment
Time frame: Since Implant of the Valve to a Maximum of 13.0 years
Evaluation of the following adverse events * Mortality (all cause and valve-related) * Reoperation/reintervention * Explant * Endocarditis * Structural valve deterioration (defined as >40 mmHg peak pulmonary gradient or >30 mmHg mean pulmonary gradient or moderately severe to severe pulmonary insufficiency) * Thrombosis * Thromboembolism (pulmonary embolism) * Non-structural dysfunction * Perivalvular leak * Bleeding * Hemolysis * Calcification

Results and safety

Results posted to the registry on 9 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Retrospective Patients	80	80
Prospective Patients	60	60

Primary outcome: Hemodynamic Performance

Time frame: Most Recent follow-up (average of 3-6 years post implant). Mean (Standard Deviation). Unit: mmHg

Measure	Retrospective Ross n = 25	Prospective Ross n = 39	Retrospective Right Ventricular Outflow Tract (RVOT) n = 47	Prospective RVOT n = 19
Peak Pulmonary Gradient	22.2 (16.0)	13.5 (10.9)	21.2 (11.4)	21.9 (12.1)
Mean Pulmonary Gradient	12.1 (8.3)	7.5 (5.7)	12.3 (6.5)	11.7 (6.7)

Population analysed: The number of participants was limited to those participants with a hemodynamic measurement provided. Therefore, the total number in each group is less than the total participants in each group.

Primary outcome: Hemodynamic Performance

Time frame: Most Recent Follow-up (average of 4 to 6 years post implant). Number. Unit: participants

Measure	Retrospective Ross n = 27	Prospective Ross n = 39	Retrospective RVOT n = 48	Prospective RVOT n = 19
None	6	12	8	3
Trivial	6	18	14	13
Mild	10	6	12	2
Moderate	2	1	10	1
Moderate-Severe	1	1	1	0
Severe	0	1	3	0

Primary outcome: Safety Assessment

Time frame: Since Implant of the Valve to a Maximum of 13.0 years. Number. Unit: percentage of patients

Measure	Ross Patients n = 68	RVOT Reconstruction Patients n = 72
10-Year Freedom from Mortality	84	97
10-Year Freedom from Valve-Related Mortality	100	100
10-Year Freedom from Reoperation/Reintervention	100	81
10-Year Freedom from Explant	100	88
10-Year Freedom from Endocarditis	100	96
10-Year Freedom from SVD	74	52
10-Year Freedom from Thrombosis	100	100
10-Year Freedom from Thromboembolism	100	100

Adverse events

Time frame: Since Implant of the Valve to a Maximum of 13 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ross Patients	5 of 68 (7.4%)	0 of 0	Not reported
RVOT Reconstruction Patients	11 of 72 (15.3%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20106397Brown JW, Elkins RC, Clarke DR, Tweddell JS, Huddleston CB, Doty JR, Fehrenbacher JW, Takkenberg JJ. Performance of the CryoValve SG human decellularized pulmonary valve in 342 patients relative to the conventional CryoValve at a mean follow-up of four years. J Thorac Cardiovasc Surg. 2010 Feb;139(2):339-48. doi: 10.1016/j.jtcvs.2009.04.065.
Background: PubMed 19699910Konuma T, Devaney EJ, Bove EL, Gelehrter S, Hirsch JC, Tavakkol Z, Ohye RG. Performance of CryoValve SG decellularized pulmonary allografts compared with standard cryopreserved allografts. Ann Thorac Surg. 2009 Sep;88(3):849-54; discussion 554-5. doi: 10.1016/j.athoracsur.2009.06.003.
Background: PubMed 12878962Hawkins JA, Hillman ND, Lambert LM, Jones J, Di Russo GB, Profaizer T, Fuller TC, Minich LL, Williams RV, Shaddy RE. Immunogenicity of decellularized cryopreserved allografts in pediatric cardiac surgery: comparison with standard cryopreserved allografts. J Thorac Cardiovasc Surg. 2003 Jul;126(1):247-52; discussion 252-3. doi: 10.1016/s0022-5223(03)00116-8.

Related trials for Pulmonary Valve Stenosis

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Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
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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.

Scott B Capps, MS study director

CryoLife, Inc.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Valve Stenosis and Pulmonary Valve Insufficiency, run by CryoLife, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 9 Dec 2015). 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?

Hemodynamic Performance (time frame: Most Recent follow-up (average of 3-6 years post implant)). The study lists 3 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 NCT01092442, which also lists 3 linked publications.

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 6 Oct 2016.