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Clinical Trial Details

Study Title: MIRACLE EF Clinical Study
Study Type: Interventional
Study Condition: Heart Failure, Left Bundle Branch Block
Investigator: Dr. Mark Landers
Phone: (910) 715-8600
Research Coordinator: Anne Dickerson
Phone: (910) 715-2200
Eligibility Criteria: Men or women ages 18 or older with a diagnosis of chronic heart failure and is on maximum tolerated (guideline) dosages of medications for heart failure, ischemic heart disease, hypertension and atrial fibrillation as appropriate. For additional criteria, call the Research Coordinator or visit the study weblink.
Sponsor Organization: Medtronic Cardiac Rhythm Disease Management
Study Rationale:
Study Purpose: This study is looking at whether the electrical treatment provided by a special type of pacemaker called a Cardiac Resynchronization Therapy (CRT) pacemaker may keep a patient's heart failure from getting worse. When the lower heart chambers (i.e. ventricles) are electrically paced to beat together by the CRT pacemaker, blood may be pumped to the body more efficiently. The CRT pacemaker being studied in this clinical trial is approved by the US Food and Drug Administration (FDA) for patients with moderate to severe heart failure, whose hearts pump blood inefficiently. In the MIRACLE EF study, patients who have heart failure with slightly less inefficient hearts will be observed to see if the electrical pacing treatment is better than not getting the treatment. This study is being conducted to support FDA approval of this type of pacemaker for people whose heart failure is less inefficient.
Study Link: http://clinicaltrials.gov/show/NCT01735916
   
 
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