Sayre, Pennsylvania 18840

  • Heart Failure

Purpose:

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.


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


Study is Available At:


Original ID:

ABT-CIP-10234


NCT ID:

NCT03564860


Secondary ID:


Study Acronym:


Brief Title:

HBP Device EGM Data Collection


Official Title:

His Bundle Pacing Device Electrogram Data Collection


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abbott Medical Devices


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

200


Enrollment Type:

Actual


Study Dates

Start Date:July 17, 2018
Completion Date:September 30, 2020
Completion Type:Actual
Primary Completion Date:September 30, 2020
Primary Completion Type:Actual
Verification Date:October 2020
Last Changed Date:October 5, 2020
First Received Date:May 15, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Amplitude of device electrogram
Time Frame:through study completion, an average of 1 year
Safety Issues:False
Description:Mean amplitude of device electrogram during His bundle pacing
Outcome Type:Primary Outcome
Measure:Duration of device electrogram
Time Frame:through study completion, an average of 1 year
Safety Issues:False
Description:Mean duration of device electrogram during His bundle pacing

Study Interventions

Intervention Type:Procedure
Name:Device data collection
Description:Collection of device electrograms and 12-lead ECG during a device follow-up visit
Arm Name:HBP device data collection group

Study Arms

Study Arm Type:Other
Arm Name:HBP device data collection group
Description: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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Abbott Medical Devices

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.