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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiologic pacing device implant | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physiologic Pacing Implant Success Rate | 849 subjects underwent attempted implants of physiologic pacing leads. Implant success rate was based on investigator-reported outcome. | 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. | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kwangdeok Lee | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research, LLC. | Huntsville | Alabama | 35801 | United States | ||
| Mills-Peninsula Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37348800 | Derived | Vazquez PM, Mohamed U, Zanon F, Lustgarten DL, Atwater B, Whinnett ZI, Curila K, Dinerman J, Molina-Lerma M, Wiley J, Grammatico A, Lee K, Vijayaraman P. Result of the Physiologic Pacing Registry, an international multicenter prospective observational study of conduction system pacing. Heart Rhythm. 2023 Dec;20(12):1617-1625. doi: 10.1016/j.hrthm.2023.06.006. Epub 2023 Jun 20. |
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A total of 870 subjects were enrolled in the registry
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 9, 2020 | Apr 25, 2023 |
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| Burlingame |
| California |
| 94010 |
| United States |
| University of California at San Diego (UCSD) Medical Center | San Diego | California | 92103 | United States |
| Yoel R. Vivas, MD | Delray Beach | Florida | 33484 | United States |
| Usman R. Siddiqui, MD | Winter Park | Florida | 32792 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| IU Health Bloomington Hospital | Bloomington | Indiana | 47403 | United States |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Charlton Memorial Hospital | Fall River | Massachusetts | 02720 | United States |
| Providence Hospital | Southfield | Michigan | 48075 | United States |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| New Mexico Heart Institute | Albuquerque | New Mexico | 87102 | United States |
| New York University Hospital | New York | New York | 10016 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Providence Heart & Vascular Institute | Portland | Oregon | 97225 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822-2150 | United States |
| Pinnacle Health System | Harrisburg | Pennsylvania | 10016 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17602 | United States |
| Allegheny General Hospital - ASRI | Pittsburgh | Pennsylvania | 15212 | United States |
| Donald Guthrie Foundation for Education and Research | Sayre | Pennsylvania | 18840 | United States |
| Texas Cardiac Arrhythmia | Austin | Texas | 78705 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Vermont College of Medicine | Burlington | Vermont | 05405-0068 | United States |
| St. Joseph Medical Center | Tacoma | Washington | 98405 | United States |
| The Northern Hospital | Epping | Victoria | 3076 | Australia |
| Mulgrave Private Hospital | Mulgrave | Victoria | 3170 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| Universitätsklinik Graz | Graz | Styria | 8036 | Austria |
| QE II Health Sciences | Halifax | Nova Scotia | B3H 3A7 | Canada |
| CHUS Fleurimont | Sherbrooke | Styria | 8036 | Canada |
| Fakultni nemocnice Kralovske Vinohrady | Prague | Central Bohemia | 100 34 | Czechia |
| CHRU Rouen Hospital Charles Nicolle | Rouen | Upper Normandy | 76031 | France |
| Clinique Ambroise Pare | Neuilly-sur-Seine | Île-de-France Region | 92200 | France |
| Herzzentrum Leipzig GmbH | Leipzig | Saxony | 04286 | Germany |
| Herz-und Diabetes Zentrum NRW | Bad Oeynhausen | 32545 | Germany |
| Prince of Wales Hospital | Hong Kong | Hong Kong SAR | 999077 | Hong Kong |
| Fortis Memorial Research Institute | Gurugramam | Haryana | 122002 | India |
| Asian Institute of Gastroenterology (AIG) Hospital | Hyderabad | 500032 | India |
| Ospedale Generale Regionale F. Miulli | Acquaviva delle Fonti | 70021 | Italy |
| Ospedale S.Maria della Misericordia | Rovigo | 45100 | Italy |
| Maastricht University Medical Center | Maastricht | 6229 HX | Netherlands |
| Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca | Katowice | 40-635 | Poland |
| National Heart Centre Singapore | Singapore | Central | 169609 | Singapore |
| NG Teng Fong General Hospital | Singapore | Central | 609606 | Singapore |
| Christiaan Barnard Memorial Hospital | Cape Town | 8001 | South Africa |
| Hospital Universitario Virgen de la Nieves | Granada | 18014 | Spain |
| Hospital General Juan Ramon Jimenez | Huelva | 21005 | Spain |
| Center Inselspital Bern | Bern | 3010 | Switzerland |
| Attempted Implant |
|
| 1-Month Follow up |
|
| 6-Month Follow up |
|
| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Physiologic Pacing Registry | The registry is a single arm study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| NYHA Class | 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. | Count of Participants | Participants |
| |||||||||||||||||
| Cardiomyopathy Type | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physiologic Pacing Implant Success Rate | 849 subjects underwent attempted implants of physiologic pacing leads. Implant success rate was based on investigator-reported outcome. | 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. | Posted | Count of Participants | Participants | During procedure |
|
|
| ||||||||||||||||||||||||||
| 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. | Subjects who did have a pacing lead implant successfully in bundle of His and complete the 6-month visit. | Posted | Mean | Standard Deviation | Volts | 6 Months |
|
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| 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. | Posted | Mean | Standard Deviation | Volts | 6 months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physiologic Pacing Registry | The registry is a single arm study | 23 | 870 | 95 | 870 | 47 | 870 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Exacerbation Of Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Extrasystole | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
| ||
| Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
| ||
| Nonsustained Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Pleural Effusion | Cardiac disorders | Systematic Assessment |
| ||
| Premature Atrial Complex | Cardiac disorders | Systematic Assessment |
| ||
| Pulmonary Edema | Cardiac disorders | Systematic Assessment |
| ||
| Rapid Atrial Flutter | Cardiac disorders | Systematic Assessment |
| ||
| Unstable Angina | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
| ||
| Gastrointestinal Bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal Lesions | Gastrointestinal disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment |
| ||
| Decrease In General State Of Health | General disorders | Systematic Assessment |
| ||
| Acute Respiratory Distress Syndrome | General disorders | Systematic Assessment |
| ||
| Bed Rest Syndrome | General disorders | Systematic Assessment |
| ||
| Cancer | General disorders | Systematic Assessment |
| ||
| Chest Pain | General disorders | Systematic Assessment |
| ||
| Exacerbation Of Heart Failure | General disorders | Systematic Assessment |
| ||
| Falls | General disorders | Systematic Assessment |
| ||
| Hypotension | General disorders | Systematic Assessment |
| ||
| Infection | General disorders | Systematic Assessment |
| ||
| Multiorgan Failure | General disorders | Systematic Assessment |
| ||
| Cholecystolithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Covid 19 Infection | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Fever Of Unknown Origin | Infections and infestations | Systematic Assessment |
| ||
| Lower Leg Swelling | Infections and infestations | Systematic Assessment |
| ||
| Pocket Erosion | Infections and infestations | Systematic Assessment |
| ||
| Worsening Mitral Regurgitation | Infections and infestations | Systematic Assessment |
| ||
| Cardiac Tamponade | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pneumothorax | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cardiogenic Shock | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Excessive Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Infection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pericardial Effusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Stroke | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Traumatic Brain Injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Twiddler's Syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Chest Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Atypical Fibroxanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Pancreatic Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Seizures | Nervous system disorders | Systematic Assessment |
| ||
| Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Lead Migration/Dislodgement | Product Issues | Systematic Assessment |
| ||
| Rise In Threshold/Elevated Pacing Threshold | Product Issues | Systematic Assessment |
| ||
| Exit Block | Product Issues | Systematic Assessment |
| ||
| Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall) | Product Issues | Systematic Assessment |
| ||
| Lead Malfunction Due To Conductor Fracture/Lead Fracture | Product Issues | Systematic Assessment |
| ||
| Loss Of Normal Device Function Due To Battery Failure Or Component Malfunction | Product Issues | Systematic Assessment |
| ||
| Pocket Erosion | Product Issues | Systematic Assessment |
| ||
| Undersensing | Product Issues | Systematic Assessment |
| ||
| Possible Post Traumatic Stress Disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Renal Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pocket Erosion | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Stroke | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complete Heart Block | Cardiac disorders | Systematic Assessment |
| ||
| Pacemaker-Mediated Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Dyspnea | General disorders | Systematic Assessment |
| ||
| Dizziness | General disorders | Systematic Assessment |
| ||
| Left Upper Extremity Edema | General disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Hematoma/Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Chest Pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Incision Site Dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Lead Migration/Dislodgement | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pneumothorax | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Swelling At Incision Site And Left Arm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Thromboemboli | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hematoma/Seroma | Investigations | Systematic Assessment |
| ||
| Lead Migration/Dislodgement | Product Issues | Systematic Assessment |
| ||
| Rise In Threshold/Elevated Pacing Threshold | Product Issues | Systematic Assessment |
| ||
| Loss Of Pacing And/Or Sensing | Product Issues | Systematic Assessment |
| ||
| Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall) | Product Issues | Systematic Assessment |
| ||
| Oversensing | Product Issues | Systematic Assessment |
| ||
| Interruption Of Desired Pulse Generator Function Due To Electrical Interference | Product Issues | Systematic Assessment |
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| Lead Malfunction Due To Conductor Fracture/Lead Fracture | Product Issues | Systematic Assessment |
| ||
| Undersensing | Product Issues | Systematic Assessment |
| ||
| Left Upper Extremity Edema | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kwangdeok Lee | Abbott | 9725269673 | kwangdeok.lee@abbott.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 5, 2021 | Apr 25, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D012804 | Sick Sinus Syndrome |
| D006327 | Heart Block |
| D013575 | Syncope |
| D009202 | Cardiomyopathies |
| D017180 | Tachycardia, Ventricular |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001146 | Arrhythmia, Sinus |
| D000075224 | Cardiac Conduction System Disease |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013610 | Tachycardia |
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| Unknown or Not Reported |
|
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Class II |
|
| Class III |
|
| Class IV |
|
|
| Idiopathic |
|
| None |
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|