Heart Failure Clinical Trial
Official title:
Assessment of AAIR Pacing Treatment for Heart Failure Patients With Chronotropic Incompetence
Verified date | January 2018 |
Source | Medtronic Cardiac Rhythm and Heart Failure |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary objective of this study is to assess the clinical efficacy of AAIR (Atrial-paced Atrial-sensed Inhibitory Rate-Modulated) pacing treatment for heart failure (HF) patients with chronotropic incompetence (CI) in terms of exercise tolerance and quality of life. Specifically, the study will assess the changes in cardiac function associated with changes of physical exercise intensity and heart rate in AAIR pacing mode compared with AAI pacing mode.
Status | Completed |
Enrollment | 11 |
Est. completion date | November 24, 2017 |
Est. primary completion date | November 24, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patient is willing to give informed consent. - Patient is between 18 and 70 years of age (including 18 and 70 years of age). - Patients can perform treadmill exercise test for at least 8 minutes. - Patient has been diagnosed with stable chronic HF according to HF guidance, including HFpEF (Heart Failure with preserved Ejection Fraction) and HFrEF (Heart Failure with reduced Ejection Fraction) patients. - NYHA class I- III, with left ventricular ejection fraction less than 55% and more than 25%. - Heart rate during treadmill test cannot reach 70% APMHR (Age Predicted Maximal Heart Rate) in (diagnostic criteria for CI, in accordance with class IA indications of pacing therapy for CI). Exclusion Criteria: - Patient with severe liver or kidney dysfunction. - Patient has contraindications for pacing therapy. - Patient has CI and is under appropriate clinical therapy. - Patient has persistent or permanent atrial fibrillation (AF). - Patient whose heart rate baseline at resting state is greater than 95 beats per minutes (BPM). - Patient has contraindications for cardio-pulmonary exercise testing, including but not limited to unstable angina, decompensated heart failure, active pericarditis or myocarditis, hypertrophic cardiomyopathy, valvular heart disease and ECG ST-segment shift > 2mm at resting state. - Less than 6 months after angina and ST dynamic changes during last 3 months. - Patient with class I (with PR interval more than 200ms), II or III atrioventricular block, or interventricular block. - NYHA Class IV. - Less than 45 days after myocardial infarction. - Less than 3 months after acute heart failure. - Patient has uncontrolled hypertension. - Patient is unwilling to sign the patient informed consent. - Patient is pregnant or has pregnancy intention in the study duration. - Patient has a medical condition that would limit study participation. - Patient is enrolled in a concurrent study that may affect the outcome of this study. |
Country | Name | City | State |
---|---|---|---|
China | Fuwai Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Medtronic Cardiac Rhythm and Heart Failure |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The treadmill walk duration change | The treadmill walk duration change from 3-6 months to 6-12 months post pacemaker implantation | ||
Secondary | The 6 minutes hall walk distance change | 3-6 months and 6-12 months post pacemaker implantation |
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