Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure
NCT ID: NCT03001674
Last Updated: 2017-05-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2014-12-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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IABP recipient
Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery.
Conductance catheterization
CD Leycom Conductance Catheter
Control
Control subjects undergoing left heart catheterization with an LV ejection fraction \> 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.
Conductance catheterization
CD Leycom Conductance Catheter
Interventions
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Conductance catheterization
CD Leycom Conductance Catheter
Eligibility Criteria
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Inclusion Criteria
* NYHA Class III-IV heart failure at the time of MEGA deployment
* Stage C-D systolic heart failure
* Non-ischemic cardiomyopathy
* Preserved right ventricular function defined by 2D-echocardiography
* Clinically indicated left and right heart catheterization and MEGA-IABP placement
* Clinically indicated MEGA-IABP support for 12 hours minimum
Exclusion Criteria
* Active myocardial ischemia or acute coronary syndrome
* Severe peripheral vascular disease
* Severe aortic or mitral valve insufficiency
* Severe aortic or mitral valve stenosis
* Right ventricular failure
* Inability to tolerate left and right heart catheterization
* Severe hemodynamic instability defined as a systolic BP \<80mmHg despite vasopressor/inotropic support
* Sustained ventricular tachycardia (\>10 beats) within 24 hours and/or ventricular fibrillation within 24 hours
* Pacemaker dependent rhythm
* Left ventricular thrombus
* Rapid atrial fibrillation (HR\>120 bpm)
* Unable to provide informed consent
* Pregnancy
18 Years
75 Years
ALL
Yes
Sponsors
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Tufts Medical Center
OTHER
Responsible Party
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Principal Investigators
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Navin Kapur, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Locations
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Tufts Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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IABP_Hemodynamics
Identifier Type: -
Identifier Source: org_study_id
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