Clinical trial NCT04489225: Personalized Therapy Study - HFRS (TriageHF) Post Approval Study
Official title: Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Failure
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2020-07-28
Enrollment: 2200
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: The study population includes all patients implanted with a Medtronic Cobalt™ XT ICD or CRT-D MRI SureScan™ (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead (ASQ)), who are enrolled in the Medtronic CareLink (CL) Network and Product Surveillance Registry (PSR).

Brief summary: Medtronic is sponsoring the HFRS PAS to evaluate the HFRS feature (TriageHF) when used in routine clinical practice following commercial release. The HFRS PAS is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

Detailed description: The HFRS PAS is a global, prospective, observational, multi-site study. Patients implanted with a Medtronic Cobalt™ XT CRT (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead (ASQ)) or ICD device who are enrolled in the Medtronic CareLink (CL) Network and the PSR will be followed per the standard of care practices of their care provider.

Eligibility criteria: Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive or be treated with an eligible ICD or CRT device or Patients may be enrolled pre-implant and up to 30 days post-implant following confirmation of patient eligibility.
* Patient is enrolled in the Medtronic CareLink® Network for remote monitoring.

Exclusion Criteria:

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results.

Primary outcomes:
measure: positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure
timeFrame: Up to 5 years
Secondary outcomes:
measure: Number of HF hospitalization or HF related deaths
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Southwest EP
state: Arizona
city: Little Rock
country: United States
facility: Saint Vincent Heart Clinic Arkansas
state: Arkansas
city: Chula Vista
country: United States
facility: Chula Vista Cardiac Center
state: California
city: Van Nuys
country: United States
facility: Cardiovascular Consultants Medical Group
state: California
city: Ventura
country: United States
facility: Cardiology Associates Medical Group
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Cardiology
state: Colorado
city: Denver
country: United States
facility: Denver Heart
state: Colorado
city: Lakewood
country: United States
facility: Colorado Heart and Vascular, PC
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Have
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Hollywood
country: United States
facility: Heart Rhythm Solutions
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health
state: Florida
city: Panama City
country: United States
facility: Cardiovascular Institute of Northwest Florida
state: Florida
city: Safety Harbor
country: United States
facility: Heart & Vascular Institute of Florida
state: Florida
city: Sarasota
country: United States
facility: Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
state: Florida
city: Evansville
country: United States
facility: Deaconess Specialty Physicians
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart
state: Iowa
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Norton Heart and Vascular Institute
state: Kentucky
city: Salisbury
country: United States
facility: TidalHealth Peninsula Regional, Inc.
state: Maryland
city: Silver Spring
country: United States
facility: Associates in Cardiology PA
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cardiovascular Specialists
state: Missouri
city: Columbia
country: United States
facility: University Hospital of Missouri
state: Missouri
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: Omaha
country: United States
facility: Nebraska Medicine
state: Nebraska
city: Eatontown
country: United States
facility: Monmouth Cardiology Associates
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Heart Group
state: New Mexico
city: Bay Shore
country: United States
facility: South Shore University Hospital
state: New York
city: Huntington
country: United States
facility: Huntington Hospital
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Mount Kisco
country: United States
facility: Northern Westchester Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York City
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital/Weill-Cornell Medical Center
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian/Columbia University Irving Medical Center
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Heart Center
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Raleigh
country: United States
facility: WakeMed Health & Hospitals
state: North Carolina
city: Akron
country: United States
facility: Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital Health Network
state: Ohio
city: Bethlehem
country: United States
facility: St Lukes University Health Network
state: Pennsylvania
city: Nashville
country: United States
facility: Saint Thomas Research Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Fort Worth
country: United States
facility: Consultants in Cardiology
state: Texas
city: Fort Worth
country: United States
facility: Heart Center of North Texas
state: Texas
city: Milwaukee
country: United States
facility: Aurora Cardiovascular Services
state: Wisconsin
city: Avignon
country: France
facility: Clinique Rhone Durance
city: Brest
country: France
facility: CHU de Brest
city: Caen
country: France
facility: CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol
city: Caen
country: France
facility: Générale de Santé - Hôpital Privé Saint Martin
city: Clermont Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
city: Dijon
country: France
facility: CHU de Dijon - Hospital Le Bocage
city: La Rochelle
country: France
facility: CHRU La Rochelle
city: Metz-Tessy
country: France
facility: Ch de La Region D'Annecy
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Saint-Priest-en-Jarez
country: France
facility: Chu Nord Saint-Étienne
city: Villeurbanne
country: France
facility: Capio - Clinique du Tonkin
city: Athens
country: Greece
facility: Hygeia Hospital
city: Maroúsi
country: Greece
facility: Athens Medical Center
city: Bologna
country: Italy
facility: Policlinico Sant' Orsola - Malpighi
city: Cosenza
country: Italy
facility: Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
city: Lecce
country: Italy
facility: Ospedale "Vito Fazzi" Lecce
city: Milano
country: Italy
facility: Azienda Ospedaliera Ospedale Niguarda Ca Granda
city: Taranto
country: Italy
facility: Presidio Ospedaliero Centrale - SS. Annunziata
city: Udine
country: Italy
facility: Azienda ospedaleria Santa Maria della Misericordia di Udine
city: Guimarães
country: Portugal
facility: Hospital da Senhora da Oliveira - Guimarães
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário de São João
city: Santarém
country: Portugal
facility: Hospital Distrital de Santarém
city: Bratislava
country: Slovakia
facility: Národný ústav srdcových a cievnych chorôb, a.s. (NÚSCH, a.s.)
city: Coruña
country: Spain
facility: Hospital Universitario da Coruña
city: Granada
country: Spain
facility: Hospital Universitario Clínico San Cecilio
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Salamanca
country: Spain
facility: Complejo Universitario de Salamanca
city: Santiago
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela
city: Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Geneve
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Zürich
country: Switzerland
facility: Cardiopark Zurich
city: Birmingham
country: United Kingdom
facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
city: Blackpool
country: United Kingdom
facility: Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital - South Tees Hospitals NHS
city: Sheffield
country: United Kingdom
facility: Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General
Study officials:
References: