Trial Outcomes & Findings for Physiologic Pacing Registry (NCT NCT03719040)
NCT ID: NCT03719040
Last Updated: 2024-08-19
Results Overview
849 subjects underwent attempted implants of physiologic pacing leads. Implant success rate was based on investigator-reported outcome.
Recruitment status
COMPLETED
Target enrollment
870 participants
Primary outcome timeframe
During procedure
Results posted on
2024-08-19
Participant Flow
A total of 870 subjects were enrolled in the registry
Participant milestones
| Measure |
Physiologic Pacing Registry
The registry is a prospective, single arm, observational, multi-center study to gain a broader understanding of physiologic pacing implant and follow-up workflows, including pacing and sensing measurements. Subjects 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 were enrolled in the registry.
|
|---|---|
|
Overall Study
STARTED
|
870
|
|
Overall Study
Attempted Implant
|
849
|
|
Overall Study
1-Month Follow up
|
731
|
|
Overall Study
6-Month Follow up
|
667
|
|
Overall Study
COMPLETED
|
667
|
|
Overall Study
NOT COMPLETED
|
203
|
Reasons for withdrawal
| Measure |
Physiologic Pacing Registry
The registry is a prospective, single arm, observational, multi-center study to gain a broader understanding of physiologic pacing implant and follow-up workflows, including pacing and sensing measurements. Subjects 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 were enrolled in the registry.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
177
|
|
Overall Study
Lost to Follow-up
|
26
|
Baseline Characteristics
NYHA classification was evaluated only in 485 subjects. The New York Heart Association (NYHA) functional classification system categorizes congestive heart failure patients based on their symptoms and physical activity limitations. The classes used in this system are I to IV, with I indicating less severity and higher numbers indicating greater severity.
Baseline characteristics by cohort
| Measure |
Physiologic Pacing Registry
n=870 Participants
The registry is a single arm study
|
|---|---|
|
Age, Continuous
|
74.9 years
STANDARD_DEVIATION 10.0 • n=870 Participants
|
|
Sex: Female, Male
Female
|
337 Participants
n=870 Participants
|
|
Sex: Female, Male
Male
|
533 Participants
n=870 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
135 Participants
n=870 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
702 Participants
n=870 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
33 Participants
n=870 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=870 Participants
|
|
Race (NIH/OMB)
Asian
|
32 Participants
n=870 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=870 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=870 Participants
|
|
Race (NIH/OMB)
White
|
789 Participants
n=870 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=870 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=870 Participants
|
|
NYHA Class
Class I
|
98 Participants
n=485 Participants • NYHA classification was evaluated only in 485 subjects. The New York Heart Association (NYHA) functional classification system categorizes congestive heart failure patients based on their symptoms and physical activity limitations. The classes used in this system are I to IV, with I indicating less severity and higher numbers indicating greater severity.
|
|
NYHA Class
Class II
|
241 Participants
n=485 Participants • NYHA classification was evaluated only in 485 subjects. The New York Heart Association (NYHA) functional classification system categorizes congestive heart failure patients based on their symptoms and physical activity limitations. The classes used in this system are I to IV, with I indicating less severity and higher numbers indicating greater severity.
|
|
NYHA Class
Class III
|
137 Participants
n=485 Participants • NYHA classification was evaluated only in 485 subjects. The New York Heart Association (NYHA) functional classification system categorizes congestive heart failure patients based on their symptoms and physical activity limitations. The classes used in this system are I to IV, with I indicating less severity and higher numbers indicating greater severity.
|
|
NYHA Class
Class IV
|
9 Participants
n=485 Participants • NYHA classification was evaluated only in 485 subjects. The New York Heart Association (NYHA) functional classification system categorizes congestive heart failure patients based on their symptoms and physical activity limitations. The classes used in this system are I to IV, with I indicating less severity and higher numbers indicating greater severity.
|
|
Cardiomyopathy Type
Non-ischemic
|
145 Participants
n=870 Participants
|
|
Cardiomyopathy Type
Ischemic
|
134 Participants
n=870 Participants
|
|
Cardiomyopathy Type
Idiopathic
|
5 Participants
n=870 Participants
|
|
Cardiomyopathy Type
None
|
586 Participants
n=870 Participants
|
PRIMARY outcome
Timeframe: During procedurePopulation: 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.
849 subjects underwent attempted implants of physiologic pacing leads. Implant success rate was based on investigator-reported outcome.
Outcome measures
| Measure |
Physiologic Pacing Registry
n=849 Participants
The registry is a single arm study
|
|---|---|
|
Physiologic Pacing Implant Success Rate
|
768 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: Subjects who did have a pacing lead implant successfully in bundle of His and complete the 6-month visit.
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.
Outcome measures
| Measure |
Physiologic Pacing Registry
n=420 Participants
The registry is a single arm study
|
|---|---|
|
Pacing Capture Threshold for His Bundle Pacing
|
1.59 Volts
Standard Deviation 0.97
|
POST_HOC outcome
Timeframe: 6 monthsThe 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.
Outcome measures
| Measure |
Physiologic Pacing Registry
n=209 Participants
The registry is a single arm study
|
|---|---|
|
Pacing Capture Threshold for Left Bundle Branch Area Pacing
|
0.79 Volts
Standard Deviation 0.33
|
Adverse Events
Physiologic Pacing Registry
Serious events: 95 serious events
Other events: 47 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Physiologic Pacing Registry
n=870 participants at risk
The registry is a single arm study
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Cardiac disorders
Exacerbation Of Heart Failure
|
0.92%
8/870 • Number of events 11 • 6 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.69%
6/870 • Number of events 6 • 6 months
|
|
Cardiac disorders
Atrial Extrasystole
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Cardiac disorders
Cardiogenic Shock
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Cardiac disorders
Coronary Artery Disease
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Cardiac disorders
Nonsustained Ventricular Tachycardia
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Cardiac disorders
Pleural Effusion
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Cardiac disorders
Premature Atrial Complex
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Cardiac disorders
Pulmonary Edema
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Cardiac disorders
Rapid Atrial Flutter
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Cardiac disorders
Unstable Angina
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Endocrine disorders
Hyperglycemia
|
0.23%
2/870 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
0.34%
3/870 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Intestinal Lesions
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
General disorders
Death
|
0.46%
4/870 • Number of events 4 • 6 months
|
|
General disorders
Decrease In General State Of Health
|
0.23%
2/870 • Number of events 2 • 6 months
|
|
General disorders
Acute Respiratory Distress Syndrome
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
General disorders
Bed Rest Syndrome
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
General disorders
Cancer
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
General disorders
Chest Pain
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
General disorders
Exacerbation Of Heart Failure
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
General disorders
Falls
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
General disorders
Hypotension
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
General disorders
Infection
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
General disorders
Multiorgan Failure
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Cholecystolithiasis
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Infections and infestations
Infection
|
2.0%
17/870 • Number of events 19 • 6 months
|
|
Infections and infestations
Covid 19 Infection
|
0.23%
2/870 • Number of events 2 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.23%
2/870 • Number of events 2 • 6 months
|
|
Infections and infestations
Fever Of Unknown Origin
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Infections and infestations
Lower Leg Swelling
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Infections and infestations
Pocket Erosion
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Infections and infestations
Worsening Mitral Regurgitation
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Cardiac Tamponade
|
0.34%
3/870 • Number of events 3 • 6 months
|
|
Injury, poisoning and procedural complications
Pneumothorax
|
0.34%
3/870 • Number of events 3 • 6 months
|
|
Injury, poisoning and procedural complications
Cardiogenic Shock
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Excessive Bleeding
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Infection
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Pericardial Effusion
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Stroke
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Traumatic Brain Injury
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Twiddler's Syndrome
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Chest Pain
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Atypical Fibroxanthoma
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Adenocarcinoma
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Nervous system disorders
Seizures
|
0.11%
1/870 • Number of events 3 • 6 months
|
|
Nervous system disorders
Stroke
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Product Issues
Lead Migration/Dislodgement
|
1.4%
12/870 • Number of events 12 • 6 months
|
|
Product Issues
Rise In Threshold/Elevated Pacing Threshold
|
0.34%
3/870 • Number of events 3 • 6 months
|
|
Product Issues
Exit Block
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Product Issues
Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall)
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Product Issues
Lead Malfunction Due To Conductor Fracture/Lead Fracture
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Product Issues
Loss Of Normal Device Function Due To Battery Failure Or Component Malfunction
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Product Issues
Pocket Erosion
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Product Issues
Undersensing
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Possible Post Traumatic Stress Disorder
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Renal Failure
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Renal Failure
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pocket Erosion
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Vascular disorders
Stroke
|
0.11%
1/870 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Physiologic Pacing Registry
n=870 participants at risk
The registry is a single arm study
|
|---|---|
|
Cardiac disorders
Complete Heart Block
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Cardiac disorders
Pacemaker-Mediated Tachycardia
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Cardiac disorders
Palpitations
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
General disorders
Dyspnea
|
0.23%
2/870 • Number of events 2 • 6 months
|
|
General disorders
Dizziness
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
General disorders
Left Upper Extremity Edema
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Infections and infestations
Infection
|
0.34%
3/870 • Number of events 3 • 6 months
|
|
Injury, poisoning and procedural complications
Hematoma/Seroma
|
0.23%
2/870 • Number of events 2 • 6 months
|
|
Injury, poisoning and procedural complications
Bruising
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Chest Pain
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Incision Site Dehiscence
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Lead Migration/Dislodgement
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Pneumothorax
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Swelling At Incision Site And Left Arm
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Thromboemboli
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Investigations
Hematoma/Seroma
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Product Issues
Lead Migration/Dislodgement
|
1.1%
10/870 • Number of events 10 • 6 months
|
|
Product Issues
Rise In Threshold/Elevated Pacing Threshold
|
1.1%
10/870 • Number of events 10 • 6 months
|
|
Product Issues
Loss Of Pacing And/Or Sensing
|
0.80%
7/870 • Number of events 7 • 6 months
|
|
Product Issues
Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall)
|
0.23%
2/870 • Number of events 2 • 6 months
|
|
Product Issues
Oversensing
|
0.23%
2/870 • Number of events 2 • 6 months
|
|
Product Issues
Interruption Of Desired Pulse Generator Function Due To Electrical Interference
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Product Issues
Lead Malfunction Due To Conductor Fracture/Lead Fracture
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Product Issues
Undersensing
|
0.11%
1/870 • Number of events 1 • 6 months
|
|
Vascular disorders
Left Upper Extremity Edema
|
0.11%
1/870 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60