BradycardiaNCT03719040
Physiologic Pacing Registry
An observational study of Bradycardia and Sinus Node Dysfunction, run by Abbott Medical Devices at 50 sites in 16 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Sinus Node Dysfunction, Heart Block
- What is being tested?
- Physiologic pacing device implant
- Type of treatment
- Medical device
- How many people
- 870 participants
- Where
- 50 sitesin 16 countries
- Study dates
- 27 Nov 2018to 7 Oct 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
- At least 18 years of age.
- Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- Provided written informed consent prior to any registry-related procedures.
Who cannot join
- History of tricuspid valve repair or replacement.
- Currently participating in another clinical study with an active treatment arm and belong to the active arm
- 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.
- Chronic physiologic pacing lead implanted
- Life expectancy of < 6 months.
- Known contraindication for physiologic pacing therapy/implant (i.e. ongoing infection, known occlusion of the subclavian vein, etc.).
Trial locations and contacts
50 sites in 16 countries.
50 sites in 16 countries
United States26 sites
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
Texas Cardiac Arrhythmia
Austin, Texas, 78705
IU Health Bloomington Hospital
Bloomington, Indiana, 47403
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mills-Peninsula Medical Center
Burlingame, California, 94010
University of Vermont College of Medicine
Burlington, Vermont, 05405-0068
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
Geisinger Medical Center
Danville, Pennsylvania, 17822-2150
Yoel R. Vivas, MD
Delray Beach, Florida, 33484
Duke University Medical Center
Durham, North Carolina, 27705
Charlton Memorial Hospital
Fall River, Massachusetts, 02720
Pinnacle Health System
Harrisburg, Pennsylvania, 10016
The Methodist Hospital
Houston, Texas, 77030
Heart Center Research, LLC.
Huntsville, Alabama, 35801
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
New York University Hospital
New York, New York, 10016
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, 15212
Providence Heart & Vascular Institute
Portland, Oregon, 97225
The Valley Hospital
Ridgewood, New Jersey, 07450
University of California at San Diego (UCSD) Medical Center
San Diego, California, 92103
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, 18840
Providence Hospital
Southfield, Michigan, 48075
St. Joseph Medical Center
Tacoma, Washington, 98405
Iowa Heart Center
West Des Moines, Iowa, 50266
Usman R. Siddiqui, MD
Winter Park, Florida, 32792
Australia3 sites
The Northern Hospital
Epping, Victoria, 3076
Mulgrave Private Hospital
Mulgrave, Victoria, 3170
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Canada2 sites
QE II Health Sciences
Halifax, Nova Scotia, B3H 3A7
CHUS Fleurimont
Sherbrooke, Styria, 8036
France2 sites
Clinique Ambroise Pare
Neuilly-sur-Seine, Île-de-France Region, 92200
CHRU Rouen Hospital Charles Nicolle
Rouen, Upper Normandy, 76031
Germany2 sites
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen, 32545
Herzzentrum Leipzig GmbH
Leipzig, Saxony, 04286
India2 sites
Fortis Memorial Research Institute
Gurugramam, Haryana, 122002
Asian Institute of Gastroenterology (AIG) Hospital
Hyderabad, 500032
Italy2 sites
Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti, 70021
Ospedale S.Maria della Misericordia
Rovigo, 45100
Singapore2 sites
National Heart Centre Singapore
Singapore, Central, 169609
NG Teng Fong General Hospital
Singapore, Central, 609606
Spain2 sites
Hospital Universitario Virgen de la Nieves
Granada, 18014
Hospital General Juan Ramon Jimenez
Huelva, 21005
Czechia1 site
Fakultni nemocnice Kralovske Vinohrady
Prague, Central Bohemia, 100 34
Netherlands1 site
Maastricht University Medical Center
Maastricht, 6229 HX
Poland1 site
Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca
Katowice, 40-635
About this study
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.
Read the 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.
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope, Cardiomyopathies, Ventricular Tachycardia
- Being tested
- Physiologic pacing device implant
- Medical subject headings
- Bradycardia, Sick Sinus Syndrome, Heart Block, Syncope, Cardiomyopathies, Tachycardia, Ventricular, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiologic pacing device implantDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologic Pacing Implant Success Rate
849 subjects underwent attempted implants of physiologic pacing leads. Implant success rate was based on investigator-reported outcome.
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start27 Nov 2018
- Primary completion7 Oct 2021
- Study completion7 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 870 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kwangdeok Lee, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719040
- Sponsor's protocol ID
- ABT-CIP-10270
- Status last verified
- Aug 2024
- First submitted
- 23 Oct 2018
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 37348800
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Pacing Registry
- ClinicalTrials.gov ID
- NCT03719040
- Acronym / sponsor ID
- ABT-CIP-10270
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope, Cardiomyopathies, Ventricular Tachycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 870 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Posted 19 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
- At least 18 years of age.
- Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- Provided written informed consent prior to any registry-related procedures.
Key exclusion criteria (6 listed)
- History of tricuspid valve repair or replacement.
- Currently participating in another clinical study with an active treatment arm and belong to the active arm
- 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.
- Chronic physiologic pacing lead implanted
- Life expectancy of < 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiologic pacing device implantAn 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. | Device | – |
Primary outcome
Physiologic Pacing Implant Success Rate
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37348800Vazquez 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwangdeok Lee study director
Abbott
50 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia and Sinus Node Dysfunction, run by Abbott Medical Devices at 50 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Australia, Canada, France, Germany and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiologic Pacing Implant Success Rate (time frame: During procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03719040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024; AzTrials last refreshed its copy on 26 Oct 2026.