Heart Valve DiseasesNCT00630916

Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

A study testing Mitroflow Aortic Heart Valve in people with Heart Valve Diseases, run by Sorin Group USA, Inc. at 26 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Valve Diseases
What is being tested?: Mitroflow Aortic Heart Valve
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 756 participants
Where: 26 sitesin 2 countries
Study dates: Nov 2003to Dec 2007
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

The subject is male or female 18 years old or older
The subject or subject's legal representative is willing to sign the informed consent
A bioprosthesis is the most suitable alternative for replacement of a dysfunctional or diseased native aortic valve or prosthesis accord gin to the current medical practice for valve selection at the center
The subject is able to return for all follow-up evaluations for the duration of the study (i.e. geographically stable

Who cannot join

The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position
The patient requires a double or triple valve replacement
The patient had a Mitroflow Heart valve during the clinical study but who then had the valve explanted
The patient has active endocarditis
The subject is or will be participating in a concomitant research study of an investigational product
The subject is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
The patient has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient the patient is pregnant or lactating

Trial locations and contacts

26 sites in 2 countries.

Country

City, postcode or hospital

26 sites in 2 countries

United States21 sites

Johns Hopkins Hospital
Baltimore, Maryland, 21287
Baylor Univ. Medical Center
Dallas, Texas, 75246
Denton Regional Medical
Denton, Texas, 76210
Hershey Medical Center
Hershey, Pennsylvania, 17033
Methodist Hospital
Indianapolis, Indiana, 46206
Heart Center of Indiana
Indianapolis, Indiana, 46240
St. Luke's Hospital
Kansas City, Missouri, 53215
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Saint Michael's Med. Center
Newark, New Jersey, 07102
Newark Beth Israel Med Ctr
Newark, New Jersey, 07112
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Hospital of the Univ. of PA
Philadelphia, Pennsylvania, 19104
Banner Good Samaritan
Phoenix, Arizona, 85006
Medical Center of Plano
Plano, Texas, 75075
Providence St. Vincent
Portland, Oregon, 97225
Mayo Clinic
Rochester, Minnesota, 55905
Sharp Memorial Hospital
San Diego, California, 92123
St. Joseph's Medical Center
Towson, Maryland, 21204
The University of Arizona
Tucson, Arizona, 85724
Westchester County Med Ctr
Valhalla, New York, 10595
Lankenau Hospital
Wynnewood, Pennsylvania, 19096

Other trials in United States

Canada5 sites

Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Hopital Laval
Québec, Quebec, G1V 4G5
Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Read the detailed description

Bioprosthetic heart valves offer several advantages over mechanical valves, the most important being freedom from the need for anticoagulation and a low rate of thromboembolic events. Pericardial bioprosthetic valves are known to have hemodynamic performance superior to porcine valves, and the excellent hemodynamic performance of pericardial valves is particularly relevant in patients with a small aortic root. However, long-term durability continues to be the main concern with use of pericardial valves. Although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation techniques and design failure rather than the pericardial tissue.The unique desing of the Mitroflow Aortic Heart Valve may provide superior hemodynamic performance over other tissue valves.

Conditions: Heart Valve Diseases
Being tested: Mitroflow Aortic Heart Valve
Keywords: Aortic valve insufficiency, Aortic valve, Aortic disease, Aortic incompetence
Medical subject headings: Heart Valve Diseases, Aortic Valve Insufficiency, Aortic Diseases

What participants receive

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

Mitroflow Aortic Heart ValveDevice
Also called Mitroflow
Replacement of the native aortic valve or a previously implanted prosthetic aortic valve

Study groups in NCT00630916
Study group	Role	What they receive
A	No intervention	Not described Receives: Device: Mitroflow Aortic Heart Valve

What is being measured

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

Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Hazard rate calculated as the number of adverse events divided by the total follow-up in years. Calculation is based on cumulative events and follow-up occurring >30 days after valve implant.
Measured: Late postoperative
Mean Gradient
Mean pressure across the Mitroflow aortic pericardial valve measured via echocardiography to assess ease of blood flow through the prosthetic valve for each valve size.
Measured: 12 months
Effective Orifice Area
Effective orifice area of the Mitroflow pericardial aortic valve measured via echocardiography to assess physiological area of blood flow through the prosthetic valve for each valve size.
Measured: 12 months

Secondary outcomes (1)

Aortic Valve Regurgitation
Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.
Measured: 12 months

Timeline

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

Nov 2003Dec 2007

First posted7 Mar 2008 (estimated)
Study startNov 2003
Primary completionDec 2005
Study completionDec 2007

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 (14)Papers the sponsor has linked to this study.
Other trials for Heart Valve DiseasesStudies 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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 756 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00630916
Sponsor's protocol ID: SYNPCR-01
Status last verified: Sep 2011
First submitted: 28 Feb 2008
Last updated: 22 Sep 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Duran CM. Pericardium in valve operations. Ann Thorac Surg. 1993 Jul;56(1):1-2. doi: 10.1016/0003-4975(93)90393-v. No abstract available.
PubMed 8328836
Cosgrove DM, Lytle BW, Gill CC, Golding LA, Stewart RW, Loop FD, Williams GW. In vivo hemodynamic comparison of porcine and pericardial valves. J Thorac Cardiovasc Surg. 1985 Mar;89(3):358-68.
PubMed 3974271
Minami K, Boethig D, Mirow N, Kleikamp G, Koertke H, Godehardt E, Koerfer R. Mitroflow pericardial valve prosthesis in the aortic position: an analysis of long-term outcome and prognostic factors. J Heart Valve Dis. 2000 Jan;9(1):112-22.
PubMed 10678383
Moggio RA, Pooley RW, Sarabu MR, Christiana J, Ho AW, Reed GE. Experience with the Mitroflow aortic bioprosthesis. J Thorac Cardiovasc Surg. 1994 Aug;108(2):215-20.
PubMed 8041169
Jamieson WR, Pelletier LC, Gerein AN, Pomar J. The Mitroflow pericardial bioprosthesis. Comparison of early clinical performance in aortic and mitral positions. Can J Surg. 1992 Apr;35(2):159-64.
PubMed 1562925
Loisance DY, Mazzucotelli JP, Bertrand PC, Deleuze PH, Cachera JP. Mitroflow pericardial valve: long-term durability. Ann Thorac Surg. 1993 Jul;56(1):131-6. doi: 10.1016/0003-4975(93)90416-f.
PubMed 8328843
Mazzucotelli JP, Bertrand PC, Loisance DY. Durability of the Mitroflow pericardial valve at ten years. Ann Thorac Surg. 1995 Aug;60(2 Suppl):S303-4. doi: 10.1016/0003-4975(95)00222-7.
PubMed 7646177
Mazzucotelli JP, Bertrand PC, Loisance DY. The Mitroflow pericardial valve: clinical performance to 10 years. J Heart Valve Dis. 1995 Jul;4(4):407-13.
PubMed 7582152
Pomar JL, Jamieson WR, Pelletier LC, Gerein AN, Castella M, Brownlee RT. Mitroflow pericardial bioprosthesis: clinical performance to ten years. Ann Thorac Surg. 1995 Aug;60(2 Suppl):S305-9; discussion S309-10. doi: 10.1016/0003-4975(95)00307-7.
PubMed 7646178
Reber D, Birnbaum DE, Tollenaere P, Eschenbruch E. Long-term results after aortic valve replacement with the Mitroflow pericardial valve. J Cardiovasc Surg (Torino). 1996 Dec;37(6 Suppl 1):23-7.
PubMed 10064343
Pomar JL, Jamieson WR, Pelletier LC, Castella M, Germann E, Brownlee RT. Mitroflow pericardial bioprosthesis experience in aortic valve replacement > or =60 years of age. Ann Thorac Surg. 1998 Dec;66(6 Suppl):S53-6. doi: 10.1016/s0003-4975(98)01129-1.
PubMed 9930417
Gersh BJ, Fisher LD, Schaff HV, Rahimtoola SH, Reeder GS, Frater RW, McGoon DC. Issues concerning the clinical evaluation of new prosthetic valves. J Thorac Cardiovasc Surg. 1986 Mar;91(3):460-6. No abstract available.
PubMed 3512921
Grunkemeier GL, Johnson DM, Naftel DC. Sample size requirements for evaluating heart valves with constant risk events. J Heart Valve Dis. 1994 Jan;3(1):53-8.
PubMed 8162217
Edmunds LH Jr, Clark RE, Cohn LH, Grunkemeier GL, Miller DC, Weisel RD. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity of The American Association for Thoracic Surgery and The Society of Thoracic Surgeons. J Thorac Cardiovasc Surg. 1996 Sep;112(3):708-11. doi: 10.1016/s0022-5223(96)70055-7. No abstract available.
PubMed 8800159

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?

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All Heart Valve Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
ClinicalTrials.gov ID: NCT00630916
Acronym / sponsor ID: SYNPCR-01
Conditions: Heart Valve Diseases
Keywords: Aortic valve insufficiency, Aortic valve, Aortic disease, Aortic incompetence
Study type: Interventional
Recruitment status: Completed
Enrolment: 756 participants (actual)
Lead sponsor: Sorin Group USA, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2003
Primary completion: Dec 2005 (actual)
Study completion: Dec 2007 (actual)
First posted: 7 Mar 2008 (estimated)
Results: Posted 20 Sep 2011

Clinical summary

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

This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
A	No intervention	Device: Mitroflow Aortic Heart Valve

Who may qualify

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

Key inclusion criteria (4 listed)

The subject is male or female 18 years old or older
The subject or subject's legal representative is willing to sign the informed consent
A bioprosthesis is the most suitable alternative for replacement of a dysfunctional or diseased native aortic valve or prosthesis accord gin to the current medical practice for valve selection at the center
The subject is able to return for all follow-up evaluations for the duration of the study (i.e. geographically stable

Key exclusion criteria (7 listed)

The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position
The patient requires a double or triple valve replacement
The patient had a Mitroflow Heart valve during the clinical study but who then had the valve explanted
The patient has active endocarditis
The subject is or will be participating in a concomitant research study of an investigational product

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
Mitroflow Aortic Heart ValveAlso: MitroflowReplacement of the native aortic valve or a previously implanted prosthetic aortic valve	Device	A

Primary outcome

Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Time frame: Late postoperative
Hazard rate calculated as the number of adverse events divided by the total follow-up in years. Calculation is based on cumulative events and follow-up occurring >30 days after valve implant.
Mean Gradient
Time frame: 12 months
Mean pressure across the Mitroflow aortic pericardial valve measured via echocardiography to assess ease of blood flow through the prosthetic valve for each valve size.
Effective Orifice Area
Time frame: 12 months
Effective orifice area of the Mitroflow pericardial aortic valve measured via echocardiography to assess physiological area of blood flow through the prosthetic valve for each valve size.

1 secondary outcome

Aortic Valve Regurgitation
Time frame: 12 months

Results and safety

Results posted to the registry on 20 Sep 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
Mitroflow Aortic Pericardial Valve	756	546

Primary outcome: Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair

Time frame: Late postoperative. Mean (95% Confidence Interval). Unit: Percent occurrence per patient-year

Measure	Mitroflow Aortic Pericardial Valve n = 699
All mortality	7.1 (5.8 to 8.6)
Valve-related mortality	1.27 (0.78 to 1.96)
Structural valve deterioration	0.21 (0.06 to 0.56)
Major anticoagulant-related bleeding	0.56 (0.27 to 1.06)
Thromboembolism	1.34 (0.83 to 2.05)
Major thromboembolic event	0.49 (0.22 to 0.97)
Valve thrombosis	0 (0 to 0.17)
Endocarditis	1.41 (0.89 to 2.13)

Population analysed: Cumulative follow-up in years occurring post 30 days

Primary outcome: Mean Gradient

Time frame: 12 months. Mean (Standard Deviation). Unit: mmHg

Measure	Mitroflow Aortic Pericardial Valve n = 544
Valve Size 19	13.4 (5)
Valve Size 21	11.4 (4.4)
Valve Size 23	10.5 (4.2)
Valve Size 25	8.6 (3.3)
Valve Size 27	7.3 (2.7)
Valve Size 29	7.3 (1.8)

Population analysed: Patients with 12 month hemodynamic evaluations

Primary outcome: Effective Orifice Area

Time frame: 12 months. Mean (Standard Deviation). Unit: cm^2

Measure	Mitroflow Aortic Pericardial Valve n = 544
Valve Size 19	1.1 (0.2)
Valve Size 21	1.2 (0.3)
Valve Size 23	1.4 (0.3)
Valve Size 25	1.6 (0.3)
Valve Size 27	1.8 (0.3)
Valve Size 29	2 (0.1)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All postop serious adverse events. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mitroflow Aortic Pericardial Valve	351 of 699 (50.2%)	430 of 699 (61.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8328836Duran CM. Pericardium in valve operations. Ann Thorac Surg. 1993 Jul;56(1):1-2. doi: 10.1016/0003-4975(93)90393-v. No abstract available.
Background: PubMed 3974271Cosgrove DM, Lytle BW, Gill CC, Golding LA, Stewart RW, Loop FD, Williams GW. In vivo hemodynamic comparison of porcine and pericardial valves. J Thorac Cardiovasc Surg. 1985 Mar;89(3):358-68.
Background: PubMed 10678383Minami K, Boethig D, Mirow N, Kleikamp G, Koertke H, Godehardt E, Koerfer R. Mitroflow pericardial valve prosthesis in the aortic position: an analysis of long-term outcome and prognostic factors. J Heart Valve Dis. 2000 Jan;9(1):112-22.
Background: PubMed 8041169Moggio RA, Pooley RW, Sarabu MR, Christiana J, Ho AW, Reed GE. Experience with the Mitroflow aortic bioprosthesis. J Thorac Cardiovasc Surg. 1994 Aug;108(2):215-20.
Background: PubMed 1562925Jamieson WR, Pelletier LC, Gerein AN, Pomar J. The Mitroflow pericardial bioprosthesis. Comparison of early clinical performance in aortic and mitral positions. Can J Surg. 1992 Apr;35(2):159-64.
Background: PubMed 8328843Loisance DY, Mazzucotelli JP, Bertrand PC, Deleuze PH, Cachera JP. Mitroflow pericardial valve: long-term durability. Ann Thorac Surg. 1993 Jul;56(1):131-6. doi: 10.1016/0003-4975(93)90416-f.
Background: PubMed 7646177Mazzucotelli JP, Bertrand PC, Loisance DY. Durability of the Mitroflow pericardial valve at ten years. Ann Thorac Surg. 1995 Aug;60(2 Suppl):S303-4. doi: 10.1016/0003-4975(95)00222-7.
Background: PubMed 7582152Mazzucotelli JP, Bertrand PC, Loisance DY. The Mitroflow pericardial valve: clinical performance to 10 years. J Heart Valve Dis. 1995 Jul;4(4):407-13.
Background: PubMed 7646178Pomar JL, Jamieson WR, Pelletier LC, Gerein AN, Castella M, Brownlee RT. Mitroflow pericardial bioprosthesis: clinical performance to ten years. Ann Thorac Surg. 1995 Aug;60(2 Suppl):S305-9; discussion S309-10. doi: 10.1016/0003-4975(95)00307-7.
Background: PubMed 10064343Reber D, Birnbaum DE, Tollenaere P, Eschenbruch E. Long-term results after aortic valve replacement with the Mitroflow pericardial valve. J Cardiovasc Surg (Torino). 1996 Dec;37(6 Suppl 1):23-7.
Background: PubMed 9930417Pomar JL, Jamieson WR, Pelletier LC, Castella M, Germann E, Brownlee RT. Mitroflow pericardial bioprosthesis experience in aortic valve replacement > or =60 years of age. Ann Thorac Surg. 1998 Dec;66(6 Suppl):S53-6. doi: 10.1016/s0003-4975(98)01129-1.
Background: PubMed 3512921Gersh BJ, Fisher LD, Schaff HV, Rahimtoola SH, Reeder GS, Frater RW, McGoon DC. Issues concerning the clinical evaluation of new prosthetic valves. J Thorac Cardiovasc Surg. 1986 Mar;91(3):460-6. No abstract available.
Click here for more information about MitroflowLink provided by the sponsor.

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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.

Mary Onxley study director

Sorin Group USA, Inc.

26 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mitroflow Aortic Heart Valve in people with Heart Valve Diseases, run by Sorin Group USA, Inc. at 26 sites in 2 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 4 inclusion and 7 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 22 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Canada. 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 20 Sep 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?

Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair (time frame: Late postoperative). 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 NCT00630916, which also lists 14 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 22 Sep 2011.