Clinical trial NCT03719040: Physiologic Pacing Registry
Official title: Physiologic Pacing Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Sinus Node Dysfunction
Heart Block
Syncope
Cardiomyopathies
Ventricular Tachycardia
Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2018-10-25
Enrollment: 870
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Physiologic Pacing Implant Success Rate
timeFrame: During procedure
measure: Pacing Capture Threshold for His Bundle Pacing
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC.
state: Alabama
city: Burlingame
country: United States
facility: Mills-Peninsula Medical Center
state: California
city: San Diego
country: United States
facility: University of California at San Diego (UCSD) Medical Center
state: California
city: Delray Beach
country: United States
facility: Yoel R. Vivas, MD
state: Florida
city: Winter Park
country: United States
facility: Usman R. Siddiqui, MD
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Bloomington
country: United States
facility: IU Health Bloomington Hospital
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Fall River
country: United States
facility: Charlton Memorial Hospital
state: Massachusetts
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: New York
country: United States
facility: New York University Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Providence Heart & Vascular Institute
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health System
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital - ASRI
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation for Education and Research
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Burlington
country: United States
facility: University of Vermont College of Medicine
state: Vermont
city: Tacoma
country: United States
facility: St. Joseph Medical Center
state: Washington
city: Epping
country: Australia
facility: The Northern Hospital
state: Victoria
city: Mulgrave
country: Australia
facility: Mulgrave Private Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Graz
country: Austria
facility: Universitätsklinik Graz
state: Styria
city: Halifax
country: Canada
facility: QE II Health Sciences
state: Nova Scotia
city: Sherbrooke
country: Canada
facility: CHUS Fleurimont
state: Styria
city: Prague
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
state: Central Bohemia
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise Pare
state: Ile-de-France
city: Rouen
country: France
facility: CHRU Rouen Hospital Charles Nicolle
state: Upper Normandy
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
state: Saxony
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabetes Zentrum NRW
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Hong Kong SAR
city: Gurugramam
country: India
facility: Fortis Memorial Research Institute
state: Haryana
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology (AIG) Hospital
city: Acquaviva Delle Fonti
country: Italy
facility: Ospedale Generale Regionale F. Miulli
city: Rovigo
country: Italy
facility: Ospedale S.Maria della Misericordia
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Katowice
country: Poland
facility: Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
state: Central
city: Singapore
country: Singapore
facility: NG Teng Fong General Hospital
state: Central
city: Cape Town
country: South Africa
facility: Christiaan Barnard Memorial Hospital
city: Granada
country: Spain
facility: Hospital Universitario Virgen de la Nieves
city: Huelva
country: Spain
facility: Hospital General Juan Ramon Jimenez
city: Bern
country: Switzerland
facility: Center Inselspital Bern
Study officials:
affiliation: Abbott
name: Kwangdeok Lee
role: STUDY_DIRECTOR
References: