An observational study in Bradycardia, Sinus Node Dysfunction and Heart Block, sponsored by Abbott Medical Devices. Completed at 50 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Abbott Medical Devices · Observational
The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements and 2) the clinical utility in creating a 3-dimensional electro-anatomical map of cardiac structures prior to physiologic pacing device implants based on the clinical site's routine care.
The Physiologic Pacing Registry will be conducted to gain a deeper understanding of physiologic pacing device implants and follow-up workflows, including device and programmer measurements to help inform Abbott's product and clinical data development efforts. Additionally, the registry will provide a broader understanding of the clinical utility in mapping physiologic pacing structures with the use of Abbott's EnSite Cardiac Mapping System with an electrophysiology catheter prior to device implants for those institutions where mapping is routine care prior to physiologic pacing device implant.
The registry will include patients undergoing implantation of an Abbott pacemaker, defibrillator, or a cardiac resynchronization therapy (CRT) pacemaker (CRT-P) or CRT defibrillator (CRT-D) according to the clinical site's routine care. Only patients scheduled to receive an Abbott device may be enrolled to ensure proper device data collection for future software and other physiologic pacing product development. The decision to provide physiologic pacing therapy and selection of devices for implant are at the discretion of the implanting physician. Abbott will collect data on the use of all commercially available leads and associated implant tools based on the physician's discretion as part of routine clinical practice within the registry.
226 studies on the registry are indexed under Syncope; 45 are open to participants now.
This study's enrollment of 870 is above the median of 221 across 91 observational studies indexed under Syncope.
Browse Syncope studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
An alternative and potentially more effective pacing strategy for patients with electrical conduction abnormalities is physiologic pacing. Physiologic pacing is achieved by delivering a pacing stimulus to a cardiac conduction structure, such as the bundle of His or left bundle branch (LBB) of the His-Purkinje system, with a permanent lead. Physiologic pacing activates the heart through the native His-Purkinje conduction system, thus offering the most physiologic pacing approach to correct electrical dyssynchrony. Physiologic pacing has emerged as a feasible and safe alternative to pacemaker therapy and CRT with clinical and electrophysiological advantages.
Physiologic Pacing Implant Success Rate
849 subjects underwent attempted implants of physiologic pacing leads. Implant success rate was based on investigator-reported outcome.
Time frame: During procedure
Pacing Capture Threshold for His Bundle Pacing
The pacing capture threshold was collected to characterize electrical performance in the Bundle of His area at 6 months. Pacing capture threshold is the minimum amount of voltage (V) needed to depolarize the myocardium or heart muscle with an electrical impulse from a pacemaker, ICD, or CRT.
Time frame: 6 Months
A total of 870 subjects were enrolled in the registry
| Milestone | Physiologic Pacing Registry |
|---|---|
| Started | 870 |
| Attempted implant | 849 |
| 1-month follow up | 731 |
| 6-month follow up | 667 |
| Completed | 667 |
| Not completed | 203 |
| Withdrew: Withdrawal by subject | 177 |
| Withdrew: Lost to follow-up | 26 |
849 subjects underwent attempted implants of physiologic pacing leads. Implant success rate was based on investigator-reported outcome.
| Participants | Physiologic Pacing Registry |
|---|---|
| Physiologic Pacing Implant Success Rate | 768 |
The pacing capture threshold was collected to characterize electrical performance in the Bundle of His area at 6 months. Pacing capture threshold is the minimum amount of voltage (V) needed to depolarize the myocardium or heart muscle with an electrical impulse from a pacemaker, ICD, or CRT.
| Volts | Physiologic Pacing Registry |
|---|---|
| Pacing Capture Threshold for His Bundle Pacing | 1.59 ± 0.97 |
The pacing capture threshold was collected to characterize electrical performance in the Left Bundle Branch area at 6 months. Pacing capture threshold is the minimum amount of voltage (V) needed to depolarize the myocardium or heart muscle with an electrical impulse from a pacemaker, ICD, or CRT.
| Volts | Physiologic Pacing Registry |
|---|---|
| Pacing Capture Threshold for Left Bundle Branch Area Pacing | 0.79 ± 0.33 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Physiologic Pacing Registry | 23/870 (2.6%) | 95/870 (10.9%) | 47/870 (5.4%) |
| Event | Physiologic Pacing Registry |
|---|---|
| InfectionInfections and infestations | 17/870 |
| Lead Migration/DislodgementProduct Issues | 12/870 |
| Exacerbation Of Heart FailureCardiac disorders | 8/870 |
| Atrial FibrillationCardiac disorders | 6/870 |
| DeathGeneral disorders | 4/870 |
| Gastrointestinal BleedingGastrointestinal disorders | 3/870 |
| Cardiac TamponadeInjury, poisoning and procedural complications | 3/870 |
| PneumothoraxInjury, poisoning and procedural complications | 3/870 |
| Rise In Threshold/Elevated Pacing ThresholdProduct Issues | 3/870 |
| HyperglycemiaEndocrine disorders | 2/870 |
| Event | Physiologic Pacing Registry |
|---|---|
| Lead Migration/DislodgementProduct Issues | 10/870 |
| Rise In Threshold/Elevated Pacing ThresholdProduct Issues | 10/870 |
| Loss Of Pacing And/Or SensingProduct Issues | 7/870 |
| InfectionInfections and infestations | 3/870 |
| DyspneaGeneral disorders | 2/870 |
| Hematoma/SeromaInjury, poisoning and procedural complications | 2/870 |
| Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall)Product Issues | 2/870 |
| OversensingProduct Issues | 2/870 |
| Complete Heart BlockCardiac disorders | 1/870 |
| Pacemaker-Mediated TachycardiaCardiac disorders | 1/870 |
The patient population for this registry was potential subjects undergoing implantation of an Abbott pacemaker, defibrillator, or CRT-P/D with any market released pacing lead as part of a physiologic pacing procedure according to the clinical site's routine care.
| Age, Continuous(years) | Physiologic Pacing Registry |
|---|---|
| Mean | 74.9 ± 10.0 |
| Sex: Female, Male(Participants) | Physiologic Pacing Registry |
|---|---|
| Female | 337 |
| Male | 533 |
| Ethnicity (NIH/OMB)(Participants) | Physiologic Pacing Registry |
|---|---|
| Hispanic or Latino | 135 |
| Not Hispanic or Latino | 702 |
| Unknown or Not Reported | 33 |
| Race (NIH/OMB)(Participants) | Physiologic Pacing Registry |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 32 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 31 |
| White | 789 |
| More than one race | 0 |
| Unknown or Not Reported | 17 |
| NYHA Class(Participants) | Physiologic Pacing Registry |
|---|---|
| Class I | 98 |
| Class II | 241 |
| Class III | 137 |
| Class IV | 9 |
| Cardiomyopathy Type(Participants) | Physiologic Pacing Registry |
|---|---|
| Non-ischemic | 145 |
| Ischemic | 134 |
| Idiopathic | 5 |
| None | 586 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
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