Clinical trial NCT04024943: Personalized Therapy Study - Attain Stability Quad Post-Approval Study
Official title: Personalized Therapy Study - Attain Stability Quad Post-Approval Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Failure
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2019-07-18
Enrollment: 1092
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes patients that are or will be implanted with a Model 4798 lead and a Medtronic CRT device.

Brief summary: The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV lead and is integrated within the Product Surveillance Registry (PSR).

Detailed description: The Attain Stability Quad (ASQ) PAS is a multi-center, single arm, prospective observational study. However, in the US, retrospective enrollments from participants in the IDE study (IDE #G170020) are allowed.

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 a Model 4798 lead and a Medtronic CRT device
* Patient within 30 days of therapy received at the time of their initial PSR platform enrollment

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: Percentage of patients without a lead- related event at 5 years post-implant
timeFrame: 5 years
Secondary outcomes:
measure: Number of lead-related adverse device effects
timeFrame: 5 years
measure: Number of explanted leads that have been returned
timeFrame: 5 years
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Heart
state: Alaska
city: Chandler
country: United States
facility: Southwest EP
state: Arizona
city: Jonesboro
country: United States
facility: Cardiology Associates of Northeast Arkansas
state: Arkansas
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: San Diego
country: United States
facility: San Diego Arrhythmia Associates
state: California
city: Torrance
country: United States
facility: COR Healthcare
state: California
city: Van Nuys
country: United States
facility: Cardiovascular Consultants Medical Group (Van Nuys)
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
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
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: Albany
country: United States
facility: Phoebe Putney Memorial Hospital
state: Georgia
city: Evansville
country: United States
facility: Deaconess Specialty Physicians
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Edgewood
country: United States
facility: Saint Elizabeth Healthcare
state: Kentucky
city: Louisville
country: United States
facility: Norton Heart Specialists
state: Kentucky
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Office of Research
state: Louisiana
city: Baltimore
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Salisbury
country: United States
facility: Tidal Health Peninsula Regional
state: Maryland
city: Silver Spring
country: United States
facility: Associates in Cardiology PA
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital (Boston, MA)
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Marquette
country: United States
facility: UP Health System - Marquette
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Robbinsdale
country: United States
facility: North Memorial Heart and Vascular Institute
state: Minnesota
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
state: Missouri
city: Omaha
country: United States
facility: Nebraska Medicine
state: Nebraska
city: Ocean City
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
country: United States
facility: New York-Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital/Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
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: Durham
country: United States
facility: Duke University Medical Center (DUMC)
state: North Carolina
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: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Erie
country: United States
facility: UPMC Heart and Vascular Institute at UPMC Hamot
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Saint Thomas Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Fort Worth
country: United States
facility: Heart Center of North Texas
state: Texas
city: Fort Worth
country: United States
facility: Consultants in Cardiology
state: Texas
city: The Woodlands
country: United States
facility: EP Heart
state: Texas
city: Spokane
country: United States
facility: Kootenai Heart Clinics Northwest
state: Washington
city: Milwaukee
country: United States
facility: Aurora Cardiovascular Services
state: Wisconsin
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque
city: Brest
country: France
facility: CHRU Brest - Hôpital de la Cavale Blanche
city: Caen
country: France
facility: Générale de Santé - Hôpital Privé Saint Martin
city: Caen
country: France
facility: CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol
city: Clermont-Ferrand
country: France
facility: CHU de Clermont Ferrand
city: Dijon
country: France
facility: CHU de Dijon - Hospital Le Bocage
city: La Rochelle
country: France
facility: CHRU La Rochelle
city: Marseille
country: France
facility: Hopital prive Clairval - Ramsay Sante
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Pringy
country: France
facility: Centre hospitalier de la région d'Annecy
city: Saint Priest en Jarez
country: France
facility: Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord
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: Castrovillari
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: Lisboa
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. (NUSCH, a.s.)
city: Coruña
country: Spain
facility: Hospital Universitario da Coruna
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Granada
country: Spain
facility: Hospital Universitario Clínico San Cecilio
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Salamanca
country: Spain
facility: Complejo Universitario de Salamanca
city: Santiago De Compostela
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: Geneva
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: