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BRADYCARE: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01062126
First received: February 2, 2010
Last updated: December 12, 2012
Last verified: December 2012

February 2, 2010
December 12, 2012
February 2010
September 2012   (final data collection date for primary outcome measure)
12 Month Follow Up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
12 months of follow up
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Complete list of historical versions of study NCT01062126 on ClinicalTrials.gov Archive Site
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BRADYCARE: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes
Advanced Bradycardia Device Feature Utilization and Clinical Outcomes

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.

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients indicated for standard Pacemaker indications

Pacemaker
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3389
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01062126
CRD525
No
St. Jude Medical
St. Jude Medical
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St. Jude Medical
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP