BRADYCARE: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes

NCT01062126 | Completed Results

• 1 other identifier: CRD525
• Study Type: observational
• Target: 3,389
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pacemaker

Keywords

Pacemaker; Advanced Features; Clinical Outcomes

Outcome Measures

Primary Outcomes (1)

• Complication Rate at 1-year Post-implant

  Complication rate and 95% confidence interval at 1-year post-implant

  12 months

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients indicated for standard Pacemaker indications

You may qualify if:

• 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 Accent™ SR/DR, Accent™ SR/DR RF, Anthem™ 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 is not pregnant or planning to become pregnant.
• Patient is \>18 years of age.

You may not qualify if:

• Patient's life expectancy is less than 12 months.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Results Point of Contact

• Title: Grant Kim
• Organization: Abbott (Previously St Jude Medical)

grant.kim1@abbott.com

818-493-3147

Study Officials

• Grant Kim

  Abbott (previously St. Jude Medical)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 4, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 14, 2020
• Results First Posted: October 14, 2020

Record last verified: 2020-09