His Bundle Pacing Registry
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|ClinicalTrials.gov Identifier: NCT03719040|
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : December 7, 2018
|Condition or disease||Intervention/treatment|
|Bradycardia Sinus Node Dysfunction Heart Block Syncope Cardiomyopathies Ventricular Tachycardia Heart Failure||Device: His bundle pacing (HBP) device implant|
The HBP Registry will be conducted to gain a deeper understanding of the HBP device implant and follow-up workflows. Additionally, the registry will provide a broader understanding of the clinical utility in mapping the His bundle with the use of Abbott's EnSite Precision™ Cardiac Mapping System with an electrophysiology catheter prior to device implants for those institutions where mapping is routine care prior to a HBP device implant.
The registry will include patients undergoing implantation of a pacemaker, defibrillator, or a cardiac resynchronization therapy (CRT) pacemaker (CRT-P) or CRT defibrillator (CRT-D) according to the clinical site's routine care. The registry will enroll up to 500 patients at up to 50 sites worldwide and will collect data at implant and at 1 and 6 months post-implant. Abbott's His bundle pacing delivery catheter will be included and evaluated in this registry once approved by each participating country's regulatory body.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||His Bundle Pacing Registry|
|Actual Study Start Date :||November 27, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||March 31, 2021|
- Device: His bundle pacing (HBP) device implant
Patients with cardiac disease may exhibit symptoms associated with electrical conduction abnormalities requiring implantation of a permanent cardiac pacing device. However, pacing is often associated with alteration of the normal electrical conduction system.
An alternative and potentially more physiologic pacing strategy for patients with electrical conduction abnormalities is HBP - this is achieved by delivering pacing stimuli at the His bundle region with a permanent lead. HBP activates the heart through the native His-Purkinje conduction system, thus offering the most physiologic pacing approach to correct electrical dyssynchrony.
- HBP implant characteristics [ Time Frame: During procedure ]Data will be collected to characterize the workflow, success, and complications associated with standard-of-care HBP implants in patients indicated for a pacemaker, defibrillator, or CRT device. Data will be compared with and without the use of the EnSite Precision Mapping System used according to each site's routine care.
- HBP follow-up characteristics [ Time Frame: 6 Months ]Data will be collected to characterize the workflow, device system electrical performance and programming, and adverse events associated with HBP implants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719040
|Contact: Jemymah C Morley||+1 email@example.com|
|Contact: Karolien Timmermans||+32 2 774 67 41||Karolien.Timmermans@abbott.com|
|United States, Alabama|
|Heart Center Research, LLC.||Recruiting|
|Huntsville, Alabama, United States, 35801|
|Contact: Jay Dinerman, MD|
|United States, Pennsylvania|
|Donald Guthrie Foundation for Education and Research||Recruiting|
|Sayre, Pennsylvania, United States, 18840|
|Contact: Pramod Deshmukh, MD|
|Study Director:||Clay Cohorn||Abbott|