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
  Purpose

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
Pacemaker

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 12 Month Follow Up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    12 months of follow up


Enrollment: 3389
Study Start Date: February 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients indicated for standard Pacemaker indications

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01062126     History of Changes
Other Study ID Numbers: CRD525
Study First Received: February 2, 2010
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 20, 2014