Ignite Creation Date:
2024-05-06 @ 1:07 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01735916
Status:
TERMINATED
Last Update Posted:
2017-11-06
First Post:
2012-11-15
Brief Title:
MIRACLE EF Clinical Study
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
MIRACLE EF Clinical Study
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated early due to low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIRACLE EF
Brief 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 patients heart failure from getting worse When the lower heart chambers ie 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
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 US and Japanese labeling for Medtronics implantable CRT-P devices and to provide further evidence to support changes to cardiology practice guidelines ACCAHA 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 21 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
Following enrollment and the baseline assessment eligible subjects will be implanted with a CRT-P system and randomized in a 21 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None