NCT01641614

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
Last Updated

July 18, 2012

Status Verified

July 1, 2012

Enrollment Period

11 months

First QC Date

July 10, 2012

Last Update Submit

July 17, 2012

Conditions

Mitral StenosisMitral Insufficiency

Keywords

Mitral valvevalve replacementarrested heartbeating heart

Outcome Measures

Primary Outcomes (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.

    1hour , 3 hours and 1 hour after surgery procedure

Secondary Outcomes (1)

  • Ultramicroscopic evidences of ischemia

    1hour, 3 hours and 1 hour after aortic clamping

Study Arms (2)

Beating heart surgery

EXPERIMENTAL

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.

Procedure: Mitral valve replacement

heart surgery Group B

ACTIVE COMPARATOR

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.

Procedure: mitral valve replacement

Interventions

mitral valve replacementPROCEDURE

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

Beating heart surgery

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Ana Neri

Salvador, Estado de Bahia, 40.000, Brazil

Location

Related Publications (17)

  • 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.

    PMID: 7065773BACKGROUND

  • 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.

    PMID: 21177299BACKGROUND

  • 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.

    PMID: 12220071BACKGROUND

  • 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.

    PMID: 12238823BACKGROUND

  • 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.

    PMID: 20026547BACKGROUND

  • 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.

    PMID: 15311869BACKGROUND

  • 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.

    PMID: 17087329BACKGROUND

  • 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.

    PMID: 17395296BACKGROUND

  • 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.

    PMID: 1709642BACKGROUND

  • 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.

    PMID: 9542436BACKGROUND

  • 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.

    PMID: 17383313BACKGROUND

  • 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.

    PMID: 18304123BACKGROUND

  • 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.

    PMID: 1992237BACKGROUND

  • 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.

    PMID: 8993249BACKGROUND

  • 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.

    PMID: 9128230BACKGROUND

  • 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.

    PMID: 8561599BACKGROUND

  • 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.

    PMID: 9830484BACKGROUND

MeSH Terms

Conditions

Mitral Valve StenosisMitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor , Profesor of Cardiac Surgery

Study Record Dates

First Submitted

July 10, 2012

First Posted

July 17, 2012

Study Start

April 1, 2010

Primary Completion

March 1, 2011

Study Completion

January 1, 2012

Last Updated

July 18, 2012

Record last verified: 2012-07

Locations

BR(1)