Expired Study
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Jonesboro, Arkansas


Purpose:

The APPROPRIATE study will compare differences in functional capacity (peak VO2) between chronotropically incompetent patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or an accelerometer (motion-based).


Criteria:

Inclusion Criteria: - Meets or met current pacemaker implantation indications - Willing and capable of providing informed consent for participation - Receiving a dual-chamber pacemaker or previously received a dual-chamber pacemaker with active atrial and ventricular leads - Plans to remain in the long-term care of his/her enrolling physician and is available for study follow-up for three months post-enrollment Exclusion Criteria: - Mobitz II second degree heart block - Third degree heart block - Chronic atrial fibrillation or uncontrolled atrial arrhythmias within the past 90 days prior to consent - Neuromuscular, orthopedic, or vascular disability that prevents normal walking or weight carrying (e.g., intermittent claudication, arthritis, residual stroke weakness, need for a wheelchair or walker) - A symptom-limited exercise protocol is thought to be dangerous or contra-indicated, including but not limited to changing pattern of chest discomfort or uncontrolled arrhythmias - Pulmonary disease as defined by any one of the following: - Forced Vital Capacity (FVC) or Forced Expiratory Volume in one second (FEV1) < 60% of predicted values - Use of two or more pulmonary inhalers - Use of supplemental oxygen - Chronic use of oral steroids for pulmonary disease treatment - Life expectancy is less than 12 months due to other medical conditions, per physician discretion - Has or indicated for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) - Currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study. - Younger than 18 years of age - Pregnant or planning to become pregnant during the study (method of assessment upon physician's discretion) - Unable or unwilling to comply with the protocol requirements


NCT ID:

NCT00757666


Primary Contact:

Principal Investigator
Michael Giudici, MD
Genesis Heart Institute


Backup Contact:

N/A


Location Contact:

Jonesboro, Arkansas
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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