Personalized Therapy Study - HFRS (TriageHF) Post Approval Study

Heart Failure Clinical Trial

Official title:

Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04489225
• Other study ID #: HFRS PAS
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: January 31, 2027

Study information

• Verified date: August 2023
• Source: Medtronic
• Contact: PSR Study Team
• Phone: 1-800-633-8766
• Email: rs.productsurveillanceregistry[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Observational
Observational only without any intervention

Locations

Country	Name	City	State
France	Clinique Rhone Durance	Avignon
France	Centre Hospitalier de la Côte Basque	Bayonne
France	CHU de Brest	Brest
France	CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol	Caen
France	Générale de Santé - Hôpital Privé Saint Martin	Caen
France	Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied	Clermont Ferrand
France	CHU de Dijon - Hospital Le Bocage	Dijon
France	CHRU La Rochelle	La Rochelle
France	Hopital prive Clairval - Ramsay Sante	Marseille
France	Ch de La Region D'Annecy	Metz-Tessy
France	Nouvelles Cliniques Nantaises	Nantes
France	Chu Nord Saint-Étienne	Saint-Priest-en-Jarez
France	Capio - Clinique du Tonkin	Villeurbanne
Greece	Hygeia Hospital	Athens
Greece	Athens Medical Center	Maroúsi
Italy	Policlinico Sant' Orsola - Malpighi	Bologna
Italy	Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"	Cosenza
Italy	Ospedale "Vito Fazzi" Lecce	Lecce
Italy	Azienda Ospedaliera Ospedale Niguarda Ca Granda	Milano
Italy	Presidio Ospedaliero Centrale - SS. Annunziata	Taranto
Italy	Azienda ospedaleria Santa Maria della Misericordia di Udine	Udine
Portugal	Hospital da Senhora da Oliveira - Guimarães	Guimarães
Portugal	Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE	Lisbon
Portugal	Centro Hospitalar Universitário de São João	Porto
Portugal	Hospital Distrital de Santarém	Santarém
Slovakia	Národný ústav srdcových a cievnych chorôb, a.s. (NÚSCH, a.s.)	Bratislava
Spain	Hospital Universitario da Coruña	Coruña
Spain	Hospital Universitario Clínico San Cecilio	Granada
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Complejo Universitario de Salamanca	Salamanca
Spain	Complejo Hospitalario Universitario de Santiago de Compostela	Santiago
Spain	Hospital Universitario Nuestra Señora de Candelaria	Tenerife
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Switzerland	Hôpitaux Universitaires de Genève	Geneve
Switzerland	Cardiopark Zurich	Zürich
United Kingdom	University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital	Birmingham
United Kingdom	Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital	Blackpool
United Kingdom	Liverpool Heart and Chest Hospital NHS Foundation Trust	Liverpool
United Kingdom	Imperial College Healthcare NHS Trust - Hammersmith Hospital	London
United Kingdom	Central Manchester University Hospitals NHS - Manchester Royal Infirmary	Manchester
United Kingdom	The James Cook University Hospital - South Tees Hospitals NHS	Middlesbrough
United Kingdom	Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General	Sheffield
United States	Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists	Akron	Ohio
United States	Presbyterian Heart Group	Albuquerque	New Mexico
United States	Alaska Heart	Anchorage	Alaska
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Our Lady of the Lake Office of Research	Baton Rouge	Louisiana
United States	South Shore University Hospital	Bay Shore	New York
United States	St Lukes University Health Network	Bethlehem	Pennsylvania
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Southwest EP	Chandler	Arizona
United States	Chula Vista Cardiac Center	Chula Vista	California
United States	The Christ Hospital Health Network	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Colorado Springs Cardiology	Colorado Springs	Colorado
United States	Missouri Cardiovascular Specialists	Columbia	Missouri
United States	University Hospital of Missouri	Columbia	Missouri
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Denver Heart	Denver	Colorado
United States	Iowa Heart	Des Moines	Iowa
United States	Duke University Medical Center (DUMC)	Durham	North Carolina
United States	Monmouth Cardiology Associates	Eatontown	New Jersey
United States	Saint Elizabeth Healthcare	Edgewood	Kentucky
United States	UPMC Heart and Vascular Institute at UPMC Hamot	Erie	Pennsylvania
United States	Deaconess Specialty Physicians	Evansville	Indiana
United States	Consultants in Cardiology	Fort Worth	Texas
United States	Heart Center of North Texas	Fort Worth	Texas
United States	Hartford Hospital	Hartford	Connecticut
United States	Heart Rhythm Solutions	Hollywood	Florida
United States	Huntington Hospital	Huntington	New York
United States	Baptist Health	Jacksonville	Florida
United States	Cardiology Associates of Northeast Arkansas	Jonesboro	Arkansas
United States	Saint Lukes Health System	Kansas City	Missouri
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	Colorado Heart and Vascular, PC	Lakewood	Colorado
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Saint Vincent Heart Clinic Arkansas	Little Rock	Arkansas
United States	Norton Heart Specialists	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	UP Health System - Marquette	Marquette	Michigan
United States	Aurora Cardiovascular Services	Milwaukee	Wisconsin
United States	Northern Westchester Hospital	Mount Kisco	New York
United States	Saint Thomas Research Institute	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Lenox Hill Hospital	New York	New York
United States	New York-Presbyterian Hospital/Weill-Cornell Medical Center	New York	New York
United States	NewYork-Presbyterian/Columbia University Irving Medical Center	New York	New York
United States	Nebraska Medicine	Omaha	Nebraska
United States	Cardiovascular Institute of Northwest Florida	Panama City	Florida
United States	Hudson Valley Heart Center	Poughkeepsie	New York
United States	WakeMed Health & Hospitals	Raleigh	North Carolina
United States	North Memorial Heart and Vascular Institute	Robbinsdale	Minnesota
United States	Mayo Clinic	Rochester	Minnesota
United States	Heart & Vascular Institute of Florida	Safety Harbor	Florida
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	TidalHealth Peninsula Regional, Inc.	Salisbury	Maryland
United States	San Diego Arrhythmia Associates	San Diego	California
United States	Heart Rhythm Consultants P.A. (Sarasota Memorial Research)	Sarasota	Florida
United States	Associates in Cardiology PA	Silver Spring	Maryland
United States	Kootenai Heart Clinics Northwest	Spokane	Washington
United States	Staten Island University Hospital	Staten Island	New York
United States	EP Heart	The Woodlands	Texas
United States	COR Healthcare	Torrance	California
United States	Cardiovascular Consultants Medical Group	Van Nuys	California
United States	Cardiology Associates Medical Group	Ventura	California
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	Michigan Heart	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  France,  Greece,  Italy,  Portugal,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure	To estimate the positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure	Up to 5 years
Secondary	Number of HF hospitalization or HF related deaths	Summarize the number of HF hospitalization or HF related deaths that were not preceded by a High-Risk Status.	Up to 5 years