Personalized Therapy Study - Attain Stability Quad Post-Approval Study
- Conditions
- Heart Failure
- Registration Number
- NCT04024943
- Lead Sponsor
- Medtronic
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1092
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients without a lead- related event at 5 years post-implant 5 years To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for Attain Stability Quad LV leads.
- Secondary Outcome Measures
Name Time Method Number of lead-related adverse device effects 5 years The secondary objectives are descriptive in nature and are intended to gain additional information about the safety and performance of the Product:
โข To summarize all Attain Stability Quad lead-related ADEsNumber of explanted leads that have been returned 5 years The secondary objectives are descriptive in nature and are intended to gain additional information about the safety and performance of the Product:
โข To summarize analysis results from explanted and returned Attain Stability Quad leads
Trial Locations
- Locations (115)
Staten Island University Hospital
๐บ๐ธStaten Island, New York, United States
Geisinger Wyoming Valley Medical Center
๐บ๐ธWilkes-Barre, Pennsylvania, United States
Massachusetts General Hospital
๐บ๐ธBoston, Massachusetts, United States
Michigan Heart
๐บ๐ธYpsilanti, Michigan, United States
North Shore University Hospital
๐บ๐ธManhasset, New York, United States
Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
๐ต๐นLisboa, Portugal
San Diego Arrhythmia Associates
๐บ๐ธSan Diego, California, United States
Duke University Medical Center (DUMC)
๐บ๐ธDurham, North Carolina, United States
Vanderbilt University Medical Center
๐บ๐ธNashville, Tennessee, United States
Policlinico Sant' Orsola - Malpighi
๐ฎ๐นBologna, Italy
Mayo Clinic
๐บ๐ธRochester, Minnesota, United States
Cardiovascular Consultants Medical Group (Van Nuys)
๐บ๐ธVan Nuys, California, United States
Cardiovascular Institute of Northwest Florida
๐บ๐ธPanama City, Florida, United States
Kansas University Medical Center
๐บ๐ธKansas City, Kansas, United States
Saint Elizabeth Healthcare
๐บ๐ธEdgewood, Kentucky, United States
Colorado Heart and Vascular
๐บ๐ธLakewood, Colorado, United States
Denver Heart
๐บ๐ธDenver, Colorado, United States
Colorado Springs Cardiology
๐บ๐ธColorado Springs, Colorado, United States
Missouri Cardiovascular Specialists
๐บ๐ธColumbia, Missouri, United States
Heart & Vascular Institute of Florida
๐บ๐ธSafety Harbor, Florida, United States
Tidal Health Peninsula Regional
๐บ๐ธSalisbury, Maryland, United States
Our Lady of the Lake Office of Research
๐บ๐ธBaton Rouge, Louisiana, United States
Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
๐บ๐ธSarasota, Florida, United States
University Hospital of Missouri
๐บ๐ธColumbia, Missouri, United States
Phoebe Putney Memorial Hospital
๐บ๐ธAlbany, Georgia, United States
UP Health System - Marquette
๐บ๐ธMarquette, Michigan, United States
MedStar Health Research Institute
๐บ๐ธBaltimore, Maryland, United States
Cardiopark Zurich
๐จ๐ญZรผrich, Switzerland
Washington University
๐บ๐ธSaint Louis, Missouri, United States
North Memorial Heart and Vascular Institute
๐บ๐ธRobbinsdale, Minnesota, United States
Presbyterian Heart Group
๐บ๐ธAlbuquerque, New Mexico, United States
South Shore University Hospital
๐บ๐ธBay Shore, New York, United States
New York-Presbyterian Hospital/Columbia University Medical Center
๐บ๐ธNew York, New York, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
๐บ๐ธNew York, New York, United States
Cleveland Clinic
๐บ๐ธCleveland, Ohio, United States
St. Luke's University Health Network
๐บ๐ธBethlehem, Pennsylvania, United States
The Christ Hospital Health Network
๐บ๐ธCincinnati, Ohio, United States
Hudson Valley Heart Center
๐บ๐ธPoughkeepsie, New York, United States
Geisinger Medical Center
๐บ๐ธDanville, Pennsylvania, United States
UPMC Heart and Vascular Institute at UPMC Hamot
๐บ๐ธErie, Pennsylvania, United States
Consultants in Cardiology
๐บ๐ธFort Worth, Texas, United States
Clinique Rhรดne Durance
๐ซ๐ทAvignon, France
CHRU Brest - Hรดpital de la Cavale Blanche
๐ซ๐ทBrest, France
Gรฉnรฉrale de Santรฉ - Hรดpital Privรฉ Saint Martin
๐ซ๐ทCaen, France
Heart Center of North Texas
๐บ๐ธFort Worth, Texas, United States
CHU de Clermont Ferrand
๐ซ๐ทClermont-Ferrand, France
Centre Hospitalier Universitaire Saint รtienne - Hรดpital Nord
๐ซ๐ทSaint Priest en Jarez, France
Presidio Ospedaliero Centrale - SS. Annunziata
๐ฎ๐นTaranto, Italy
CHU de Dijon - Hospital Le Bocage
๐ซ๐ทDijon, France
CHRU La Rochelle
๐ซ๐ทLa Rochelle, France
Centre hospitalier de la rรฉgion d'Annecy
๐ซ๐ทPringy, France
Capio - Clinique du Tonkin
๐ซ๐ทVilleurbanne, France
Hospital da Senhora da Oliveira - Guimarรฃes
๐ต๐นGuimarรฃes, Portugal
Azienda Ospedaliera Ospedale Niguarda Ca Granda
๐ฎ๐นMilano, Italy
Azienda ospedaleria Santa Maria della Misericordia di Udine
๐ฎ๐นUdine, Italy
Hopital prive Clairval - Ramsay Sante
๐ซ๐ทMarseille, France
Nouvelles Cliniques Nantaises
๐ซ๐ทNantes, France
Athens Medical Center
๐ฌ๐ทMaroรบsi, Greece
Hospital Universitario 12 de Octubre
๐ช๐ธMadrid, Spain
Hospital Universitario da Coruna
๐ช๐ธCoruรฑa, Spain
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
๐ฌ๐งBirmingham, United Kingdom
Central Manchester University Hospitals NHS - Manchester Royal Infirmary
๐ฌ๐งManchester, United Kingdom
Nebraska Medicine
๐บ๐ธOmaha, Nebraska, United States
Hospital Clรญnico Universitario de Valladolid
๐ช๐ธValladolid, Spain
Chula Vista Cardiac Center
๐บ๐ธChula Vista, California, United States
COR Healthcare
๐บ๐ธTorrance, California, United States
Baptist Health
๐บ๐ธJacksonville, Florida, United States
Cardiology Associates Medical Group
๐บ๐ธVentura, California, United States
Clearwater Cardiovascular Consultants
๐บ๐ธClearwater, Florida, United States
Deaconess Specialty Physicians
๐บ๐ธEvansville, Indiana, United States
Huntington Hospital
๐บ๐ธHuntington, New York, United States
Long Island Jewish Medical Center
๐บ๐ธNew Hyde Park, New York, United States
Northern Westchester Hospital
๐บ๐ธMount Kisco, New York, United States
Kootenai Heart Clinics Northwest
๐บ๐ธSpokane, Washington, United States
EP Heart
๐บ๐ธThe Woodlands, Texas, United States
University of Cincinnati
๐บ๐ธCincinnati, Ohio, United States
Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
๐บ๐ธAkron, Ohio, United States
Hospital Universitario Clรญnico San Cecilio
๐ช๐ธGranada, Spain
Heart Rhythm Solutions
๐บ๐ธHollywood, Florida, United States
Iowa Heart Center
๐บ๐ธWest Des Moines, Iowa, United States
Sparrow Clinical Research Institute
๐บ๐ธLansing, Michigan, United States
Lenox Hill Hospital
๐บ๐ธNew York, New York, United States
Centre Hospitalier de la Cรดte Basque
๐ซ๐ทBayonne, France
CHU de Caen - Hรดpital Cรดte de Nacre - Centre Esquirol
๐ซ๐ทCaen, France
Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
๐ฎ๐นCastrovillari, Italy
Ospedale "Vito Fazzi" Lecce
๐ฎ๐นLecce, Italy
Centro Hospitalar Universitรกrio de Sรฃo Joรฃo
๐ต๐นPorto, Portugal
Hospital Universitario Virgen de las Nieves
๐ช๐ธGranada, Spain
Complejo Hospitalario Universitario de Santiago de Compostela
๐ช๐ธSantiago De Compostela, Spain
Complejo Universitario de Salamanca
๐ช๐ธSalamanca, Spain
Hospital Universitario Nuestra Seรฑora de Candelaria
๐ช๐ธTenerife, Spain
The James Cook University Hospital - South Tees Hospitals NHS
๐ฌ๐งMiddlesbrough, United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Hospital
๐ฌ๐งLondon, United Kingdom
Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital
๐ฌ๐งBlackpool, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
๐ฌ๐งLiverpool, United Kingdom
Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General
๐ฌ๐งSheffield, United Kingdom
WakeMed Health & Hospitals
๐บ๐ธRaleigh, North Carolina, United States
Norton Heart Specialists
๐บ๐ธLouisville, Kentucky, United States
Saint Lukes Health System
๐บ๐ธKansas City, Missouri, United States
Hygeia Hospital
๐ฌ๐ทAthens, Greece
Nรกrodnรฝ รบstav srdcovรฝch a cievnych chorรดb, a.s. (NUSCH, a.s.)
๐ธ๐ฐBratislava, Slovakia
Hartford Hospital
๐บ๐ธHartford, Connecticut, United States
Saint Vincent Heart Clinic Arkansas
๐บ๐ธLittle Rock, Arkansas, United States
Alaska Heart
๐บ๐ธAnchorage, Alaska, United States
Cardiology Associates of Northeast Arkansas
๐บ๐ธJonesboro, Arkansas, United States
Southwest EP
๐บ๐ธChandler, Arizona, United States
Yale New Haven Hospital
๐บ๐ธNew Haven, Connecticut, United States
Brigham & Women's Hospital (Boston, MA)
๐บ๐ธBoston, Massachusetts, United States
Hospital Distrital de Santarรฉm
๐ต๐นSantarรฉm, Portugal
Monmouth Cardiology Associates
๐บ๐ธOcean City, New Jersey, United States
Aurora Cardiovascular Services
๐บ๐ธMilwaukee, Wisconsin, United States
Hรดpitaux Universitaires de Genรจve
๐จ๐ญGeneva, Switzerland
Saint Thomas Research Institute
๐บ๐ธNashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
๐บ๐ธAustin, Texas, United States
Associates in Cardiology PA
๐บ๐ธSilver Spring, Maryland, United States