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Trial record 21 of 62 for:    "Sick Sinus Syndrome"

HBP Device EGM Data Collection

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ClinicalTrials.gov Identifier: NCT03564860
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date May 15, 2018
First Posted Date June 21, 2018
Last Update Posted Date February 1, 2019
Actual Study Start Date July 17, 2018
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2018)
  • Amplitude of device electrogram [ Time Frame: through study completion, an average of 1 year ]
    Mean amplitude of device electrogram during His bundle pacing
  • Duration of device electrogram [ Time Frame: through study completion, an average of 1 year ]
    Mean duration of device electrogram during His bundle pacing
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03564860 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title HBP Device EGM Data Collection
Official Title His Bundle Pacing Device Electrogram Data Collection
Brief Summary

This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac resynchronization device. Prospective data collection includes surface electrocardiograms, intracardiac electrograms, and pacing parameters, recorded during a patient visit. Additional retrospective data collection includes procedural data during the HB pacing lead and device implant.

Up to 200 subjects will participate in this clinical investigation. The clinical investigation will be conducted at up to 8 centers worldwide.

The total duration of the clinical investigation is expected to be 1 year, including enrollment and data collection from all subjects.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The intended population for this clinical investigation consists of patients over the age of 18 years who have been previously implanted with a permanent His Bundle pacing lead and an Abbott pacemaker, defibrillator, or cardiac resynchronization therapy device.
Condition
  • Sick Sinus Syndrome
  • AV Block
  • Heart Failure
Intervention Procedure: Device data collection
Collection of device electrograms and 12-lead ECG during a device follow-up visit
Study Groups/Cohorts HBP device data collection group
Device electrograms and 12-lead ECG will be collected from patients over the age of 18 years who have been previously implanted with a permanent His Bundle pacing lead and an Abbott pacemaker, defibrillator, or cardiac resynchronization therapy device during a standard-of-care device follow-up visit.
Intervention: Procedure: Device data collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 19, 2018)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Has previously implanted with Abbott device and any pacing lead at HB
  • Age ≥ 18 years
  • Ability to provide informed consent for study participation
  • Willing to comply with study evaluation requirements

Exclusion Criteria:

  • Suspected pacing system failure
  • Lead impedance out of range
  • Ventricular sensing amplitude lower than 0.5 mV
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Wenwen Li, PhD 408-522-6207 wenwen.li@abbott.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03564860
Other Study ID Numbers ABT-CIP-10234
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators Not Provided
PRS Account Abbott Medical Devices
Verification Date January 2019