Retrospective

Cheuk Man Yu

Rm.12A28, 12/F, main building, PWH

2632 1752

cmyu@cuhk.edu.hk / poonsp@cuhk.edu.hk

Nil

Cheuk Man Yu

Rm.12A28, 12/F, main building, PWH

2632 1752

cmyu@cuhk.edu.hk / poonsp@cuhk.edu.hk

Nil

對患有心臟衰竭並接受心肌收縮力調節治療的病人，利用多維立體超聲波影像技術，評估其心臟功能改變的研究

Yes

2009-03-25

Device

Echocardiography assesses the Changes in Cardiac Function of heart failure by Cardiac Contractility Modulation.

4 years

Patient fulfilled into the study criteria will be enrolled. Baseline testing included echocardiography with RT3DE and TDI, Minnesota Living with Heart Failure Questionnaire (MLWHFQ), 6-minute hall walk test (6MHW), maximal oxygen consumption test on treadmill test and 24-hour Holter monitor. Patients will be implanted with CCM. They will be followed up at pre-determined time-points where assessment will be repeated, i.e. 1week, 1 month and 3 months. After 3-month of CCM treatment, the device will be switch off. Patients will be maintained with no CCM treatment for 1 month at which time clinical and echocardiographic assessment will be repeated. Afterwards, CCM will be restarted and patient will continue with long-term follow up and assessment.

1). Heart failure (HF) patients with left ventricular ejection fraction less than or equal to 35% by echocardiography and New York Heart Association Class III or IV
2). Have been treated with optimal anti-HF medications with doses not varying by more than 50% for a minimum of 4 weeks, e.g. diuretics, Angiotensin Converting Enzyme Inhibitors or Angiotensin Receptor Blocker, β-blockers, etc.
3). QRS duration < 130ms or if QRS > 130ms, deemed not a candidate of cardiac resynchronization therapy by in-charge physicians
4). If clinically indicated, patient has automatic implantable cardiac defibrillator (ICD) and/or cardiac pacemaker; if patient has a clinical indication for such device(s) but is not already implanted, patient may be enrolled if simultaneous implantation of the appropriate device is scheduled

1). Subjects with severe symptomatic HF who would qualify for heart transplant, who have recently (within 3 months) been treated with intravenous inotropic agents or whose baseline VO2,max is known to be <11 ml/kg/min
2). Subjects who have a potentially correctible cause of HF, such as valvular heart disease or congenital heart disease.
3). Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days of enrollment, or angina and/or ECG changes during exercise testing performed during baseline evaluation.
4). Subjects who have been hospitalized for HF which required the use of intravenous diuretics or inotropic support within two weeks of enrollment.
5). Subjects without an implantable cardioverter defibrillator (ICD) who have a documented history of sustained VT, or who have an indication for an ICD and are not scheduled for ICD implantation at the time of CCM.
6). Subjects who have an ICD who have had appropriate ICD firing during the past one month.
7). Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 premature ventricular contractions per 24 hours on baseline Holter monitoring (which reduce significantly reducing the amount of CCM delivery).
8). Subjects who have chronic atrial fibrillation or chronic atrial flutter.
9). Subjects whose exercise tolerance is limited by a condition other than HF (e.g., angina, chronic obstructive pulmonary disease, peripheral vascular disease, orthopedic or rheumatologic conditions).
10). Subjects who are unable to participate in a 6-minute hall walk or a cardiopulmonary stress test.
11). Subjects who are scheduled for a coronary revascularization (CABG or PCI) procedure, or who have undergone a CABG procedure within three months or a PCI procedure within one month of enrollment.
12). Subjects who have a biventricular pacemaker or whose primary care physician(s) believes a biventricular pacemaker is indicated.
13). Subjects who have had a myocardial infarction within three months of enrollment.
14). Subjects who have mechanical tricuspid or aortic valves.
15). Subjects who have a prior heart transplant.
16). Subjects who have a previously implanted ICD which employs unipolar or integrated bipolar sensing
17). Subjects who are participating in another experimental protocol.
18). Subjects who are unable to provide informed consent.

Patient > 18 years of age

Patient > 18 years of age

Both Male and Female

Non-randomized

Active

Open label

Parallel

No