LIFE Study - Limiting Chronotropic Incompetence for Pacemaker Recipients
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This study will compare how two different sensors inside the pacemaker may affect patients' quality of life.
Condition or disease
Device: sensor programming
The LIFE Study will estimate the prevalence of CI among a general sample of pacemaker patients and compare changes in quality of life and physical activity between patients randomized to receive rate response driven by either blended sensor or accelerometer. Changes in chronotropic response between CI patients randomized to either blended sensor or accelerometer will be compared. A sub-study will evaluate changes in functional capacity between CI patients randomized to either blended sensor or accelerometer.
Determine the prevalence of CI among a general sample of pacemaker patients, compare differences in quality of life and physical activity between patients programmed to either blended sensor or accelerometer
Secondary Outcome Measures :
Evaluate changes in chronotropic response among CI patients who are randomized to receive adaptive rate therapy driven by either blended sensor or accelerometer
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients who meet current INSIGNIATM Plus pacemaker indications
Patients who sign and date a Patient Informed Consent prior to device implant
Patients who remain in the clinical care of the enrolling physician
Patients whose previous pacemaker had a minute ventilation sensor
Patients who have neuromuscular, orthopedic, or vascular disability that prevents normal walking (e.g., intermittent claudication, arthritis, residual stroke weakness, need for a wheelchair or walker)
Patients in whom a symptom-limited exercise protocol is thought to be dangerous because of coronary artery disease or other cardiac disease
Uncontrolled arrhythmias (e.g., chronic atrial fibrillation, frequent/persistent atrial fibrillation, ventricular arrhythmias, or patients with ablate and pace whose arrhythmia continues to be uncontrolled)
Patients whose medical condition is expected to preclude the use of the protocol-required primary pacing mode (i.e., DDD or DDDR)
Patients whose life expectancy is less than 12-months due to other medical conditions
Patients who have or who are indicated for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
Patients who have active chronic leads that are either single-pass VDD, unipolar ventricular and atrial, non-IS-1, and non-3.2mm UNLESS the leads are replaced with bipolar leads that are IS-1/3.2mm compatible
Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study. Each instance should be brought to the attention of Guidant's Clinical Application Research Studies (CARS) group to determine eligibility
Patients who are younger than 18 years of age
Patients who are pregnant
Patients who are mentally incompetent and cannot sign a Patient Informed Consent or participate in the study