BRADYCARE: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes (BRADYCARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01062126
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : December 17, 2012
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:

Pacemaker technology is constantly evolving. In the past 10 years, numerous advancements have been made in pacemaker therapy, diagnostics and connectivity. These advancements include automated capture, automated sensing, patient alert functions, algorithms minimizing ventricular pacing, automatic mode switching in response to atrial tachyarrhythmia, rate responsive pacing, advanced diagnostic features, remote monitoring and radiofrequency (RF) technology. However, little information is available on how these new features are being utilized by physicians in the real world and how these features impact patient outcomes.

This observational study will gather data on the patients' presenting clinical status, indication for device implantation, utilization of advanced device features, device therapy choices, clinical management and outcomes in a general pacemaker population.

The primary aim of the study is to evaluate the usage of advanced features and diagnostics in patients with St. Jude Medical pacemakers. The secondary aim of the study is to learn more about the progressive clinical outcomes in the general pacemaker patient population. The tertiary aim of the study is to evaluate the correlation between the usage of advanced features in pacemaker patients and the patient's clinical outcomes.

Condition or disease

Detailed Description:

Evaluation of Device Features and Diagnostics

  • Programmed parameters: Advanced pacemaker features (Autocapture, Auto sensitivity control (ASC), Ventricular Intrinsic Preference (VIP®), Patient Notifier, RF telemetry, and newer advanced features)
  • Device and lead measurements
  • Number of AT/AF, VT/VF, PMT and AMS episodes

Evaluation of Clinical Parameters

  • Indication for device implantation
  • Cardiac and arrhythmia history
  • Cardiac drug utilization
  • Cardiac events: incidence and onset of symptomatic atrial fibrillation (AF), onset of heart failure (HF), incidence and onset of angina, occurrence of myocardial infarction (MI), occurrence of transient ischemic attack (TIA)/ischemic stroke, and occurrence of hemorrhagic stroke
  • Modified Specific Activity Scale (SAS)
  • Intrinsic QRS duration
  • Left ventricular ejection fraction (LVEF)
  • Adverse events
  • All-cause, cardiovascular and heart failure hospitalizations
  • All-cause, cardiovascular and heart failure mortality

Study Type : Observational
Actual Enrollment : 3389 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes
Study Start Date : February 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Primary Outcome Measures :
  1. 12 Month Follow Up [ Time Frame: 12 months ]
    12 months of follow up

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients indicated for standard Pacemaker indications

Inclusion Criteria:

  • Patient has a current indication for a single-chamber (SR) or dual-chamber (DR) pacemaker or CRT-P device.
  • Patient is implanted with an SJM AccentTM SR/DR, AccentTM SR/DR RF, AnthemTM CRT-P, Anthem™ CRT-P RF, or newer SJM pacemaker device.
  • Patient is geographically stable and willing to comply with the required follow-up schedule.
  • Patient's life expectancy is more than 24 months.
  • Patient is not pregnant or planning to become pregnant.
  • Patient is >18 years of age.

Responsible Party: St. Jude Medical Identifier: NCT01062126     History of Changes
Other Study ID Numbers: CRD525
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

Keywords provided by St. Jude Medical:
Advanced Features
Clinical Outcomes

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes