Clinical trial NCT02746471: Reveal LINQ Registry
Official title: Medtronic Reveal LINQ Insertable Cardiac Monitor Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias, Cardiac
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2016-04-21
Enrollment: 1604
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients intended to receive a market-released Reveal LINQ device are eligible to enroll in the Registry. All enrolled patients that have an attempted procedure will be included in the analysis. Consented patients who failed to receive a Reveal LINQ device may be exited from the registry when all reportable events are resolved.

Brief summary: The Reveal LINQ Registry will generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information.

Detailed description: The study is a prospective, non-randomized, observational, multi-center, global study. The study will characterize clinical actions initiated by Reveal LINQ arrhythmia detection and estimate procedure-related acute infection rate. Approximately 1,500 subjects will be implanted with a Reveal LINQ ICM and undergo continuous remote monitoring and be followed prospectively from insertion through 36 months.

Eligibility criteria: Inclusion Criteria:

* Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
* Subject is intended to receive or be treated with the have a Reveal LINQ ICM inserted in the next 30 days.
* Patient enrolled before or on the same date of insertion of the Reveal LINQ ICM
* Subject consent prior to ICM insertion

Exclusion Criteria:

* Subject who is, or is expected to be inaccessible for follow-up
* Subject with exclusion criteria required by local law
* Subject is currently enrolled in or plans to enroll a concurrent study that may confound the results of this study. Co-enrollment in any concurrent drug and/or device clinical study (including registries) requires approval of the study manager or designee.

Primary outcomes:
measure: Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature
timeFrame: Implant to 36 months post-implant
measure: Number of Participants With Procedure-related Acute Infection Rate
timeFrame: Implant to 30 days post-implant
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco UCSF Medical Center
state: California
city: Jacksonville
country: United States
facility: Jacksonville Heart (Baptist Medical)
state: Florida
city: Tampa
country: United States
facility: Bay Heart Group
state: Florida
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Kansas City
country: United States
facility: Saint Lukes Health System
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Dallas
country: United States
facility: Baylor Research Institute (Dallas-TX)
state: Texas
city: Fort Worth
country: United States
facility: Baylor Research Institute (Fort Worth TX)
state: Texas
city: Plano
country: United States
facility: Baylor Research Institute (Plano TX)
state: Texas
city: Milwaukee
country: United States
facility: Aurora Cardiovascular Services
state: Wisconsin
city: Leuven
country: Belgium
facility: Ziekenhuis Oost Limburg - Campus St.-Jan
city: Athens
country: Greece
facility: Evaggelismos Hospital
city: Tel HaShomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Negrar
country: Italy
facility: Ospedale classificato ed equiparato Sacro Cuore
city: Rovereto
country: Italy
facility: Presidio Ospedaliero Santa Maria del Carmine
city: Fukuoka City
country: Japan
facility: National Kyushu Medical Center
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
city: Kitakyushu City
country: Japan
facility: Hospital of the University of Occupational and Environmental Health
city: Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital
city: Mitaka
country: Japan
facility: Kyorin University Hospital
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
city: Ogaki City
country: Japan
facility: Ogaki Municipal Hospital
city: Okayama city
country: Japan
facility: Okayama University Hospital
city: Shinagawa-Ku
country: Japan
facility: Showa University Hospital
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
city: Tokyo
country: Japan
facility: The Jikei University School of Medicine Hospital
city: Tokyo
country: Japan
facility: Toho University Omori Medical Center
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum (MUMC)
city: Carnaxide
country: Portugal
facility: Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz
city: Guimarães
country: Portugal
facility: Hospital Senhora da Oliveira, Guimaraes
city: Lisboa
country: Portugal
facility: Centro Hospitarlar Lisboa Norte - Hospital de Santa Maria
city: Ponta Delgada
country: Portugal
facility: Hospital do Espirito Santo
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto - Hospital de Santo Antonio
city: Santarém
country: Portugal
facility: Hospital Distrital de Santarem
city: Jeddah
country: Saudi Arabia
facility: King Fahd Armed Forces Hospital
city: Riyadh
country: Saudi Arabia
facility: Prince Sultan Cardiac Center
Study officials:
affiliation: The Valley Hospital
name: Suneet Mittal, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beinart SC, Natale A, Verma A, Amin A, Kasner S, Diener HC, Del Greco M, Wilkoff BL, Pouliot E, Franco N, Mittal S. Real-world comparison of in-hospital Reveal LINQ insertable cardiac monitor insertion inside and outside of the cardiac catheterization or electrophysiology laboratory. Am Heart J. 2019 Jan;207:76-82. doi: 10.1016/j.ahj.2018.10.002. Epub 2018 Oct 14.