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Mitral StenosisPhase 4BAHMVRNCT01641614

Beating Versus Arrested Heart for Mitral Valve Replacement

A Phase 4 study testing Mitral valve replacement in people with Mitral Stenosis and Mitral Insufficiency, run by Federal University of Bahia at 1 site in Brazil.

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 evaluate the immediately clinic and ultramicroscopic myocardial cellular ischemia and reperfusion to replace of the mitral valve using arrested heart versus on-pump empty beating heart surgical techniques. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Mitral Stenosis, Mitral Insufficiency
What is being tested?
Mitral valve replacement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteBrazil
Study dates
Apr 2010to Jan 2012
Phase
Phase 4
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • all patient included into the study were adults 18-60 years old,
  • with an echocardiography diagnosis of mitral and/or tricuspid valve disease due to inflammatory acquired diseases,
  • no previous history of cardiac surgery and d) elective indication for valve replacement.

Who cannot join

  • with metabolic diseases such as diabetes mellitus and uremia,
  • with coronary artery diseases,
  • dilated myocardiopathy,
  • with severe chronic pulmonary obstructive diseases,
  • with present or past history of malignant diseases,
  • acute endocarditis
  • with severe pre-operatory laboratory parameters such as creatinine levels > 3mg/dL, Hemoglobin ≤ 7.0 g/dL, Prothrombin time/activity ≤ 70% and clotting time ≥ 10 minutes.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital Ana Neri

    Salvador, Estado de Bahia, 40.000

Other trials in Brazil

About this study

Official title: Clinical and Ultramicroscopic Myocardial Randomized Study of On-Pump Beating Heart Mitral Valve Replacement

The purpose of this study is to evaluate the immediately clinic and ultramicroscopic myocardial cellular ischemia and reperfusion to replace of the mitral valve using arrested heart versus on-pump empty beating heart surgical techniques.

Read the detailed description

During open-heart surgery prevention of ischemia and reperfusion following cardioplegic arrest are essential for myocardial protection. Beating heart surgery on normothermic bypass simulates physiologic cardiac status and is good method for myocardial protection. A comparison of both available techniques for valve replacement arrested heart versus on-pump empty beating heart of the clinical and ultramicroscopic myocardial alterations will allowed to better understand myocardial protection because eliminated the use of cardioplegia and the corollary risk of ischemic reperfusion injury.

Being tested
Mitral valve replacement
Keywords
Mitral valve, valve replacement, arrested heart, beating heart
Medical subject headings
Mitral Valve Stenosis, Mitral Valve Insufficiency

What participants receive

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

  • Mitral valve replacementProcedure or surgery

    Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture. For the beating heart the prostheses was functionally tested before removal of the retrograde perfusion catheter and for the arrested heart the prosthesis was artificially tested by pumping saline into the left ventricle. The tricuspid valve repair was done following De Vegas' technique in both groups

  • mitral valve replacementProcedure or surgery

    Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture. For the beating heart the prostheses was functionally tested before removal of the retrograde perfusion catheter and for the arrested heart the prosthesis was artificially tested by pumping saline into the left ventricle. The tricuspid valve repair was done following De Vegas' technique in both groups

Study groups in NCT01641614
Study groupRoleWhat they receive
Beating heart surgeryExperimentalGroup A (Beating heart) surgery was performed under normal temperature (36⁰ C) ,once CPB was established, the patient was placed in Trendelenburg position and a retrograde perfusion catheter was inserted into the coronary sinus and ligated by a simple suture line. Aorta cross clamping was immediately established and blood was oxygenated and delivered continuously through a catheter Mitral valve was exposed using the left atrial retractor. Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture De Vegas' technique.
Receives: Procedure: Mitral valve replacement
heart surgery Group BActive comparatorGroup B (arrested heart) surgery was performed under moderate hypothermia (32⁰C) as technique requirement (3). After cardiac arrest, during the period of cross clamping, the aortic root was perfused through the cardioplegias's cannula with oxygenated blood at a rate between 200 mL/min to 300 mL/min for 2 minutes with 15 minutes intervals.Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture De Vegas' technique.
Receives: Procedure: mitral valve replacement

What is being measured

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

  1. mitral valve replacement

    Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture. For the beating heart the prostheses was functionally tested before removal of the retrograde perfusion catheter and for the arrested heart the prosthesis was artificially tested by pumping saline into the left ventricle. The tricuspid valve repair was done following De Vegas' technique in both groups with the beating heart also in the group B.

    Measured: 1hour , 3 hours and 1 hour after surgery procedure

Secondary outcomes (1)

  1. Ultramicroscopic evidences of ischemia

    During the surgery myocardial biopsies were performed as full thickness transmural specimen of three small fragments for electromicrospic analysis

    Measured: 1hour, 3 hours and 1 hour after aortic clamping

Timeline

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

  1. First posted17 Jul 2012 (estimated)
  2. Study startApr 2010
  3. Primary completionMar 2011
  4. Study completionJan 2012

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01641614
Sponsor's protocol ID
REQ:690
Acronym
BAHMVR
Status last verified
Jul 2012
First submitted
10 Jul 2012
Last updated
18 Jul 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Schaper J, Schwarz F, Kittstein H, Stammler G, Winkler B, Scheld H, Hehrlein F. The effects of global ischemia and reperfusion on human myocardium: quantitative evaluation by electron microscopic morphometry. Ann Thorac Surg. 1982 Feb;33(2):116-22. doi: 10.1016/s0003-4975(10)61895-4.

    PubMed 7065773

  • Babaroglu S, Yay K, Parlar AI, Ates C, Mungan U, Cicekcioglu F, Tutun U, Katircioglu SF. Beating heart versus conventional mitral valve surgery. Interact Cardiovasc Thorac Surg. 2011 Mar;12(3):441-7. doi: 10.1510/icvts.2010.255240. Epub 2010 Dec 21.

    PubMed 21177299

  • Kaplon RJ, Pham SM, Salerno TA. Beating-heart valvular surgery: a possible alternative for patients with severely compromised ventricular function. J Card Surg. 2002 Mar-Apr;17(2):170-2. doi: 10.1111/j.1540-8191.2002.tb01194.x.

    PubMed 12220071

  • Matsumoto Y, Watanabe G, Endo M, Sasaki H, Kasashima F, Kosugi I. Efficacy and safety of on-pump beating heart surgery for valvular disease. Ann Thorac Surg. 2002 Sep;74(3):678-83. doi: 10.1016/s0003-4975(02)03753-0.

    PubMed 12238823

  • Salhiyyah K, Taggart D. Beating-heart valve surgery: A systematic review. Asian Cardiovasc Thorac Ann. 2009 Dec;17(6):650-8. doi: 10.1177/0218492309348942.

    PubMed 20026547

  • Ghosh S, Jutley RS, Wraighte P, Shajar M, Naik SK. Beating-heart mitral valve surgery in patients with poor left ventricular function. J Heart Valve Dis. 2004 Jul;13(4):622-7; discussion 627-9.

    PubMed 15311869

  • Mizuno T, Arai H. On-pump beating-heart mitral valve plasty without aortic cross-clamping. Jpn J Thorac Cardiovasc Surg. 2006 Oct;54(10):454-7. doi: 10.1007/s11748-006-0031-4.

    PubMed 17087329

  • Bara C, Zhang R, Haverich A. De Vega annuloplasty for tricuspid valve repair in posttraumatic tricuspid insufficiency--16 years experience. Int J Cardiol. 2008 Jun 6;126(3):e61-2. doi: 10.1016/j.ijcard.2007.01.027. Epub 2007 Mar 29.

    PubMed 17395296

  • Hassan HT, Veit A, Maurer HR. Synergistic interactions between differentiation-inducing agents in inhibiting the proliferation of HL-60 human myeloid leukaemia cells in clonogenic micro assays. J Cancer Res Clin Oncol. 1991;117(3):227-31. doi: 10.1007/BF01625429.

    PubMed 1709642

  • Herrera JM, Cuenca J, Campos V, Rodriguez F, Vicente Valle J, Juffe A. [Coronary surgery without extracorporeal circulation: 5-year experience]. Rev Esp Cardiol. 1998 Feb;51(2):136-40. Spanish.

    PubMed 9542436

  • Karolak W, Hirsch G, Buth K, Legare JF. Medium-term outcomes of coronary artery bypass graft surgery on pump versus off pump: results from a randomized controlled trial. Am Heart J. 2007 Apr;153(4):689-95. doi: 10.1016/j.ahj.2007.01.033.

    PubMed 17383313

  • Karadeniz U, Erdemli O, Yamak B, Genel N, Tutun U, Aksoyek A, Cicekcioglu F, Parlar AI, Katircioglu SF. On-pump beating heart versus hypothermic arrested heart valve replacement surgery. J Card Surg. 2008 Mar-Apr;23(2):107-13. doi: 10.1111/j.1540-8191.2007.00536.x.

    PubMed 18304123

  • Lichtenstein SV, Ashe KA, el Dalati H, Cusimano RJ, Panos A, Slutsky AS. Warm heart surgery. J Thorac Cardiovasc Surg. 1991 Feb;101(2):269-74.

    PubMed 1992237

  • Kamlot A, Bellows SD, Simkhovich BZ, Hale SL, Aoki A, Kloner RA, Kay GL. Is warm retrograde blood cardioplegia better than cold for myocardial protection? Ann Thorac Surg. 1997 Jan;63(1):98-104. doi: 10.1016/s0003-4975(96)01074-0.

    PubMed 8993249

  • Eke CC, Gundry SR, Fukushima N, Bailey LL. Is there a safe limit to coronary sinus pressure during retrograde cardioplegia? Am Surg. 1997 May;63(5):417-20.

    PubMed 9128230

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mitral valve replacement in people with Mitral Stenosis and Mitral Insufficiency, run by Federal University of Bahia at 1 site in Brazil.

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 3 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 18 Jul 2012. 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 Brazil. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

mitral valve replacement (time frame: 1hour , 3 hours and 1 hour after surgery procedure). 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 NCT01641614, which also lists 17 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 18 Jul 2012.

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