NCT01735916

MIRACLE EF Clinical Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Medtronic, Inc. is sponsoring the MIRACLE EF study, a prospective, randomized, controlled, double-blinded, global multi-center, Cardiac Resynchronization Therapy (CRT) in Heart Failure (HF) clinical study. The purpose of this study is to evaluate market released CRT pacemaker (CRT-P) devices in symptomatic HF patients with less severe left ventricular systolic dysfunction, specifically patients with reduced left ventricular ejection fraction (LVEF) in the range of 36% to 50%. This study will support expansion of indications for CRT worldwide. The outcome of this study is expected to support modification of existing U.S. and Japanese labeling for Medtronic's implantable CRT-P devices and to provide further evidence to support changes to cardiology practice guidelines (ACC/AHA, ESC guidelines) regarding the use of CRT in patients with mild to moderate HF. Following enrollment and the baseline assessment, eligible subjects will be implanted with a CRT-P system and randomized in a 2:1 fashion to either treatment (CRT-P ON) or control (CRT-P OFF) groups. Study subjects will be followed for a minimum of 24 months or until study closure, and will remain in their randomized groups until their 60 month visit or until the study is stopped, whichever comes first. The effectiveness of CRT-P in this population will be assessed using a composite endpoint of time to first event, with event defined as All-cause mortality or HF Event. To assess the safety of CRT-P in this population, the primary safety endpoint will measure freedom from system-related complications at 6 months post-implant.

Conditions

• Congestive Heart Failure
• Left Bundle Branch Block
• Systolic Heart Failure

Interventions

Type	Name	Description
DEVICE	CRT-P Implant	The Medtronic Consulta CRT-P (models C3TR01, C4TR011) dual chamber implantable pacemaker with cardiac resynchronization therapy (CRT-P) is a multi-programmable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, and sequential biventricular pacing. The device senses the electrical activity of the patient's heart using the electrodes of the implanted atrial and right ventricular leads. It then analyzes the heart rhythm based on selectable detection parameters. The device responds to bradyarrhythmias by providing bradycardia pacing therapy. Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
DEVICE	CRT-P OFF	Device programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-11-28
• Last updated: 2017-11-06
• Results posted: 2014-10-06

Locations

73 sites across 5 countries: United States, India, Russia, Sweden, United Kingdom