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Beating Versus Arrested Heart for Mitral Valve Replacement (BAHMVR)

Primary Purpose

Mitral Stenosis, Mitral Insufficiency

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Mitral valve replacement
mitral valve replacement
Sponsored by
Federal University of Bahia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Stenosis focused on measuring Mitral valve, valve replacement, arrested heart, beating heart

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Ana Neri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Beating heart surgery

heart surgery Group B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 10, 2012
Last Updated
July 17, 2012
Sponsor
Federal University of Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT01641614
Brief Title
Beating Versus Arrested Heart for Mitral Valve Replacement
Acronym
BAHMVR
Official Title
Clinical and Ultramicroscopic Myocardial Randomized Study of On-Pump Beating Heart Mitral Valve Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Stenosis, Mitral Insufficiency
Keywords
Mitral valve, valve replacement, arrested heart, beating heart

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beating heart surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
heart surgery Group B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Mitral valve replacement
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
mitral valve replacement
Intervention Description
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
Primary Outcome Measure Information:
Title
mitral valve replacement
Description
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.
Time Frame
1hour , 3 hours and 1 hour after surgery procedure
Secondary Outcome Measure Information:
Title
Ultramicroscopic evidences of ischemia
Description
During the surgery myocardial biopsies were performed as full thickness transmural specimen of three small fragments for electromicrospic analysis
Time Frame
1hour, 3 hours and 1 hour after aortic clamping

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Ana Neri
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40.000
Country
Brazil

12. IPD Sharing Statement

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Beating Versus Arrested Heart for Mitral Valve Replacement

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