Heart Failure Heart Failure
Conditions
Interventions
The subjects will be randomly assigned in a 1:1 ratio to Treatment group (aCRT ON, with AdaptivCRT programmed to Adaptive Bi-V and LV) or Control group (aCRT OFF, with AdaptivCRT programmed to Nonadap
Sponsors
Kusano Kengo
Sekiguchi Hideaki
Medtronic Japan Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is willing to sign and date the study Informed Consent Form (ICF). 2. Subject is indicated for a CRT device according to local guidelines. 3. Subject has minimally: 4. Sinus rhythm at time of enrollment. 5. LBBB as documented on an ECG(preferably within 30 day s prior to enrollment but up to 50 days is accepted) with moderately wide QRS: 6. Intrinsic QRS duration >=120 ms and =2 of leads V1, V2, V5, V6, I, and aVL. 9. Intrinsic, normal AV conduction as documented on a recent ECG by a PR interval <=200 ms (preferably within 30 days prior to enrollment but up to 50 days is accepted). 10. Left ventricular ejection fraction <=35% (documented within 180 days prior to enrollment). 11. NYHA class II, III or IV (documented within 30 days prior to enrollment) despite optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose of Beta-blockers and a therapeutic dose of ACE-I, ARB or MRA.
Exclusion criteria
Exclusion criteria: 1. Subject is less than 18 years of age (or has not reached minimum age per local law if that is higher). 2. Subject is not expected to remain available for at least 1 year of follow-up visits. 3. Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted. 4. Subject is, or previously has been, receiving cardiac resynchronization therapy. 5. Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager. 6. Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 30 days prior to enrollment. 7. Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study. 8. Subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded). 9. Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study. 10. Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to device implant). 11. Subject meets any exclusion criteria required by local law.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test the hypothesis that aCRT ON (Adaptive Bi-V and LV) increases the proportion of patients that improve on the Clinical Composite Score (CCS) compared to aCRT OFF (Nonadaptive CRT) at 6 months of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the change in NYHA class at 6 and 12 months between the aCRT ON group and the aCRT OFF group. 2. To characterize the occurrence of hospitalizations for worsening heart failure in the aCRT ON group and the aCRT OFF group at 12 months. 3. To characterize all-cause and cardiovascular related mortality in the aCRT ON group and the aCRT OFF group at 12 months. | — |
Countries
Brunei, China, Hong Kong, Indonesia, Japan, Korea, Malaysia, Philippines, Singapore, Taiwan
Contacts
Public ContactChikako Tokudome
National Cerebral and Cardiovascular Center
Outcome results
None listed