heart failure
Conditions
Interventions
Treatment Arm: aCRT ON
Control Arm: aCRT OFF
Sponsors
University of Tsukuba, Faculty of Medicine, Cardiovascular Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Subject is willing to sign and date the study patient informed consent form. (2)Subject is 20 years old and over. (3),Subject is expected to remain available for at least 6 months of follow-up visits. (4)Subject is indicated for a CRT device according to local guidelines within 60 days after writing the informed consent form. (5)Subject has, o Sinus Rhythm with preserved AV conduction at time of enrollment. o moderately wide left bundle branch block (LBBB)as documented on an ECG. o Left ventricular ejection fraction less than or equal to 35%. o NYHA class III or IV despite optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose of Beta- blockersand a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist.
Exclusion criteria
Exclusion criteria: (1)Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted (2)Subject is, or previously has been, receiving CRT. (3)Subject has a previously implanted lead with damage or unstable measurement value. (4)Subject already has medical condition which may limit the participation to the trial. (5)Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. (6)Subject has unstable angina, or experienced an acute myocardial infarction or received coronary artery revascularization or coronary angioplasty 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 has a limited life expectancy due to non-cardiac causes that would not allow completion of the study. (9)Subject is pregnant. (10)Subject meets any exclusion criteria by research representative.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical composite score at 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in left ventricular end-systolic volume Change in left ventricular ejection fraction Changes in NYHA functional class Changes in 6-minute hall walk test Changes in scores of Minnesota living with heart failure quality of life assessment Time to first heart failure hospitalization Time to all death and cardiovascular death | — |
Countries
Japan
Contacts
Public ContactHiro Yamasaki
University of Tsukuba, Faculty of Medicine Cardiovascular Division
Outcome results
None listed