Bradycardia, Cardiomyopathies, Heart Block, Heart Failure, Sinus Node Dysfunction, Syncope, Ventricular Tachycardia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPhysiologic pacing device implant
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.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Scheduled for implantation of an Abbott pacemaker, defibrillator, or CRT-P/D device with any commercially available pacing lead as part of a physiologic pacing procedure according to the clinical site's routine care. 2. At least 18 years of age. 3. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations. 4. Provided written informed consent prior to any registry-related procedures.
Exclusion criteria
1. History of tricuspid valve repair or replacement. 2. Currently participating in another clinical study with an active treatment arm and belong to the active arm 3. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the registry or to comply with follow-up requirements, or impact the scientific soundness of the registry results. 4. Chronic physiologic pacing lead implanted 5. Life expectancy of \< 6 months. 6. Known contraindication for physiologic pacing therapy/implant (i.e. ongoing infection, known occlusion of the subclavian vein, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiologic Pacing Implant Success Rate | During procedure | 849 subjects underwent attempted implants of physiologic pacing leads. Implant success rate was based on investigator-reported outcome. |
| Pacing Capture Threshold for His Bundle Pacing | 6 Months | 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. |
Countries
Australia, Austria, Canada, Czechia, France, Germany, Hong Kong, India, Italy, Netherlands, Poland, Singapore, South Africa, Spain, Switzerland, United States
Participant flow
Recruitment details
A total of 870 subjects were enrolled in the registry
Participants by arm
| Arm | Count |
|---|---|
| Physiologic Pacing Registry The registry is a single arm study | 870 |
| Total | 870 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 26 |
| Overall Study | Withdrawal by Subject | 177 |
Baseline characteristics
| Characteristic | Physiologic Pacing Registry |
|---|---|
| Age, Continuous | 74.9 years STANDARD_DEVIATION 10 |
| Cardiomyopathy Type Idiopathic | 5 Participants |
| Cardiomyopathy Type Ischemic | 134 Participants |
| Cardiomyopathy Type None | 586 Participants |
| Cardiomyopathy Type Non-ischemic | 145 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 135 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 702 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 33 Participants |
| NYHA Class Class I | 98 Participants |
| NYHA Class Class II | 241 Participants |
| NYHA Class Class III | 137 Participants |
| NYHA Class Class IV | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 32 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants |
| Race (NIH/OMB) White | 789 Participants |
| Sex: Female, Male Female | 337 Participants |
| Sex: Female, Male Male | 533 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 23 / 870 |
| other Total, other adverse events | 47 / 870 |
| serious Total, serious adverse events | 95 / 870 |
Outcome results
Primary
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
Population: Subjects who did have a pacing lead implant successfully in bundle of His and complete the 6-month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physiologic Pacing Registry | Pacing Capture Threshold for His Bundle Pacing | 1.59 Volts | Standard Deviation 0.97 |
Primary
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
Population: The patient population for this analysis includes subjects underwent 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Physiologic Pacing Registry | Physiologic Pacing Implant Success Rate | 768 Participants |
Post Hoc
Pacing Capture Threshold for Left Bundle Branch Area Pacing
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physiologic Pacing Registry | Pacing Capture Threshold for Left Bundle Branch Area Pacing | 0.79 Volts | Standard Deviation 0.33 |