- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01641614
Beating Versus Arrested Heart for Mitral Valve Replacement (BAHMVR)
July 17, 2012 updated by: Clotario Neptali Carrasco Cueva, Federal University of Bahia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Bahia
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Salvador, Bahia, Brazil, 40.000
- Hospital Ana Neri
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Beating heart surgery
Group 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.
|
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
|
Active Comparator: heart surgery Group B
Group 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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mitral valve replacement
Time Frame: 1hour , 3 hours and 1 hour after surgery procedure
|
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.
|
1hour , 3 hours and 1 hour after surgery procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultramicroscopic evidences of ischemia
Time Frame: 1hour, 3 hours and 1 hour after aortic clamping
|
During the surgery myocardial biopsies were performed as full thickness transmural specimen of three small fragments for electromicrospic analysis
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1hour, 3 hours and 1 hour after aortic clamping
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Gundry SR, Wang N, Sciolaro CM, Van Arsdell GS, Razzouk AJ, Hill AC, Bailey LL. Uniformity of perfusion in all regions of the human heart by warm continuous retrograde cardioplegia. Ann Thorac Surg. 1996 Jan;61(1):33-5. doi: 10.1016/0003-4975(95)00880-2.
- Pena E, Solano L, Portillo Z, Meertens de Rodriguez L. [Nutritional status of institutionalized elderly. Valencia, State of Carabobo, Venezuela]. Arch Latinoam Nutr. 1998 Jun;48(2):104-11. Spanish.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
July 10, 2012
First Submitted That Met QC Criteria
July 16, 2012
First Posted (Estimate)
July 17, 2012
Study Record Updates
Last Update Posted (Estimate)
July 18, 2012
Last Update Submitted That Met QC Criteria
July 17, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REQ:690
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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