Reveal LINQ Registry

Arrhythmias, Cardiac Clinical Trial

Official title:

Medtronic Reveal LINQ Insertable Cardiac Monitor Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746471
• Other study ID #: Reveal LINQ Registry
• Status: Completed
• Start date: April 2014
• Est. completion date: June 4, 2021

Study information

• Verified date: March 2022
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1604
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

Intervention

Device:
• Reveal LINQ

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost Limburg - Campus St.-Jan	Leuven
Greece	Evaggelismos Hospital	Athens
Israel	The Chaim Sheba Medical Center	Tel HaShomer
Italy	Ospedale classificato ed equiparato Sacro Cuore	Negrar
Italy	Presidio Ospedaliero Santa Maria del Carmine	Rovereto
Japan	National Kyushu Medical Center	Fukuoka City
Japan	Saitama Medical University International Medical Center	Hidaka
Japan	Hirosaki University Hospital	Hirosaki
Japan	Hospital of the University of Occupational and Environmental Health	Kitakyushu City
Japan	Saiseikai Kumamoto Hospital	Kumamoto
Japan	Kyorin University Hospital	Mitaka
Japan	Iwate Medical University Hospital	Morioka
Japan	Ogaki Municipal Hospital	Ogaki City
Japan	Okayama University Hospital	Okayama city
Japan	Showa University Hospital	Shinagawa-Ku
Japan	National Cerebral and Cardiovascular Center	Suita
Japan	The Jikei University School of Medicine Hospital	Tokyo
Japan	Toho University Omori Medical Center	Tokyo
Japan	Fujita Health University Hospital	Toyoake
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Maastricht Universitair Medisch Centrum (MUMC)	Maastricht
Portugal	Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz	Carnaxide
Portugal	Hospital Senhora da Oliveira, Guimaraes	Guimarães
Portugal	Centro Hospitarlar Lisboa Norte - Hospital de Santa Maria	Lisboa
Portugal	Hospital do Espirito Santo	Ponta Delgada
Portugal	Centro Hospitalar do Porto - Hospital de Santo Antonio	Porto
Portugal	Hospital Distrital de Santarem	Santarém
Saudi Arabia	King Fahd Armed Forces Hospital	Jeddah
Saudi Arabia	Prince Sultan Cardiac Center	Riyadh
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	The Christ Hospital	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Baylor Research Institute (Dallas-TX)	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Iowa Heart Center	Des Moines	Iowa
United States	Baylor Research Institute (Fort Worth TX)	Fort Worth	Texas
United States	Jacksonville Heart (Baptist Medical)	Jacksonville	Florida
United States	Saint Lukes Health System	Kansas City	Missouri
United States	Aurora Cardiovascular Services	Milwaukee	Wisconsin
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	NYU Langone Medical Center	New York	New York
United States	Baylor Research Institute (Plano TX)	Plano	Texas
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of California San Francisco UCSF Medical Center	San Francisco	California
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Bay Heart Group	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Belgium,  Greece,  Israel,  Italy,  Japan,  Netherlands,  Portugal,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature	Clinical actions taken over the course of study follow-up	Implant to 36 months post-implant
Primary	Number of Participants With Procedure-related Acute Infection Rate	Acute infection rate in the subjects who were followed for at least 30 days or had an infection prior to 30 days. Infections are as assessed by the Investigator and defined as deep incision site or superficial infection.; Deep incision site are classified as pain, redness, or drainage at incision site requiring the device to be removed or IV antibiotics administered.; Superficial infections are defined as redness beyond procedure expectation and oral antibiotics administered.; For both deep incision and superficial infections, a physician directed intervention must occur for the event to be defined as an infection.	Implant to 30 days post-implant