Download The benefits of CRT for NYHA II-III HF patients with a wide QRS, low

Miracle EF Clinical Study (CRT in Heart Failure Patients with LBBB and LVEF 36-50%)
Steering Committee: Cecilia Linde , Anne Curtis , Gregg Fonarow , Kerry Lee , William Little , Anthony Tang , Francisco Leyva , Shin-ichi Momomura , and Martin Cowie
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Karolinska Institutet, Stockholm Sweden; 2University at Buffalo, Buffalo, NY; 3University of California at Los Angeles; 4Duke University, Durham, NC; 5University of Mississippi, Oxford, MS; 6Victoria Cardiac Arrhythmia Trials , Victoria, BC, Canada; 7Queen Elizabeth Hospital, University of Birmingham, UK; 8Jichi Medical University, Saitama, Japan;
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The Royal Brompton Hospital, London, UK
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Patient Criteria
• The benefits of CRT for NYHA II-III HF
patients with a wide QRS, low LVEF ≤ 35%
and optimal medical therapy is established
• The benefits are greater with wider
QRS duration and/or LBBB, demonstrating
the role of electrical dyssynchrony
• However, the effect of LVEF on CRT
outcomes is less clear. Recent sub-studies
indicate that CRT benefit may be present
over the full range of reduced LVEF*
A 80
70.2
Percent of patients
70
P = 0.23
62.8
60
Under 35
Over 35
50
40
30
18.6
20
17.1
12.7
18.6
10
0
Unchanged
Improved
B 80
P = 0.23
70
Percent of patients
Worsened
57.8
60
Under 35
Over 35
50.8
50
40
34.5
34.9
30
20
14.3
7.6
10
0
> 15% Decrease
Unchanged
> 15% Increase
A) Improved clinical composite score.
B) Reduction in left ventricular end systolic volume by 15% or more.
There were no significant differences between groups.
Methods
• Prospective, randomized, controlled,
double-blinded, parallel comparison,
global, multi-center clinical trial
• 2,900 subject to achieve sample of
2,300 implants at up to 275 centers
worldwide (up to 200 US)
• Event driven study design,
4 interim analyses
• Minimum follow-up duration
of 24 months or until study closure
Identify Potential Subject
No
(LBBB, NYHA Class II/III, No device)
Yes
No Further Action
Subject Signs Consent
Yes
Confirm Eligibility and
Complete Baseline Testing
Yes
CRT Implant
Yes
Subject Randomized
2:1
CRT ON
No
No
No
No
CRT OFF
Subject Exit
Objectives
Inclusion
Exclusion
• Chronic heart failure
• LVEF between 36% and 50%
• LBBB with QRS ≥ 130 ms
• Patient is either:
– NYHA Class III OR
– NYHA Class II, with hospitalization for
HF in the last 12 months OR
– NYHA Class II, without hospitalization
for HF, but with BNP ≥ 250 pg/ml or
NT-proBNP > 1,000 pg/ml
• Sinus rhythm at time of enrollment
• Optimal medical therapy per guidelines
for Heart Failure, Ischemic Heart Disease
(IHD), Hypertension, and Atrial Fibrillation,
as applicable
• No additions to or subtractions from
non-diuretic heart failure medical therapy
within prior 30 days
• Indicated for implantable cardioverter
defibrillator (ICD)
• CRT-P, pacemaker, ICD or CRT-D device
implanted
• Mechanical tricuspid heart valve
• Unstable angina or an acute MI within
past 40 days
• Coronary artery bypass graft (CABG)
or percutaneous coronary intervention
(PCI) within the past 90 days
• Chronic (permanent) atrial arrhythmias
• Cardioversion for atrial fibrillation within
the past 30 days
• Life expectancy of less than 24 months
due to non-cardiac conditions.
• < 18 years of age
• Significant renal dysfunction
• Significant hepatic dysfunction
Primary Efficacy: Time to first event will be assessed, defined as:
• All-cause mortality, or
•H
F Event, defined as either:
Inpatient hospitalization for HF, or
Outpatient event requiring invasive clinical intervention and management
for HF (i.e., IV diuretics, ultrafiltration, or equivalent) and overnight stay
Primary Safety: System-related complication-free at 6 months > 80%
Status
Study Status: Enrolling
Study Start Date: January 2013
Estimated Study Completion Date: 2018, if full duration of follow-up
Contacts
Contact: C
hristopher Manrodt, Trial Leader
[email protected]
Sponsor: Medtronic, Inc.
(Monitor)
1-Month, 3-Month, and 6-Month Follow-Up
6-Month Follow-Ups Until Study Closure
Funding: Medtronic, Inc.
ClinicalTrials.gov: NCT01735916
* Chung, et al. Eur J Heart Fail. 2010;12:581-587.
UC201402550 EN © Medtronic, Inc. 2013. Minneapolis, MN. All Rights Reserved. Printed in USA. 09/2013
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