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NCT04024943Active, not recruiting

Personalized Therapy Study - Attain Stability Quad Post-Approval Study

Source: ClinicalTrials.gov · Last updated 4 Feb 2026

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
1092 (actual)
First submitted
24 Jun 2019
Start date
21 Aug 2017
Primary completion date
31 Jul 2027
Lead sponsor
Medtronic
NCT number
NCT04024943

What you commit to

  • Study type: Observational
  • Participants enrolled: 1092
  • From 21 Aug 2017 to the primary completion date, 31 Jul 2027
  • 115 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Other

  • Patient who is, or is expected to be inaccessible for follow-up
  • Patient with exclusion criteria required by local law

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (115)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpitaux universitaires de Genève
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GenevaSwitzerlandUnknown status
Cardiopark Zurich
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ZurichSwitzerlandUnknown status
Hospital Universitario da Coruña
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A CoruñaSpainUnknown status
Hospital Universitario Clínico San Cecilio
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GranadaSpainUnknown status
Hospital Universitario Virgen de las Nieves
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GranadaSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Complejo Universitario de Salamanca
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SalamancaSpainUnknown status
Hospital Universitario Nuestra Señora de Candelaria
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Santa Cruz de TenerifeSpainUnknown status
Complejo Hospitalario Universitario De Santiago De Compostela
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Santiago de CompostelaSpainUnknown status
Hospital Clínico Universitario de Valladolid
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ValladolidSpainUnknown status
Clinique Rhône Durance
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AvignonFranceUnknown status
Centre Hospitalier de la Cote Basque
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BayonneFranceUnknown status
CHRU Brest - Hôpital de la Cavale Blanche
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BrestFranceUnknown status
CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol
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CaenFranceUnknown status
Générale de Santé - Hôpital Privé Saint Martin
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CaenFranceUnknown status
CHU de Clermont-Ferrand
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Clermont-FerrandFranceUnknown status
CHU de Dijon - Hospital Le Bocage
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DijonFranceUnknown status
CHRU La Rochelle
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La RochelleFranceUnknown status
Hopital prive Clairval - Ramsay Sante
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MarseilleFranceUnknown status
Nouvelles Cliniques Nantaises
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NantesFranceUnknown status
Centre Hospitalier de la Région d'Annecy
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PRINGYFranceUnknown status
Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord
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Saint-Priest-en-JarezFranceUnknown status
Capio - Clinique du Tonkin
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VilleurbanneFranceUnknown status
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
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BirminghamUnited KingdomUnknown status
Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital
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BlackpoolUnited KingdomUnknown status
Liverpool Heart and Chest Hospital NHS Foundation Trust
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LiverpoolUnited KingdomUnknown status
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
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LondonUnited KingdomUnknown status
Central Manchester University Hospitals NHS - Manchester Royal Infirmary
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ManchesterUnited KingdomUnknown status
The James Cook University Hospital - South Tees Hospitals NHS
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MiddlesbroughUnited KingdomUnknown status
Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General
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SheffieldUnited KingdomUnknown status
HYGEIA Hospital
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AthensGreeceUnknown status
Athens Medical Center
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MarousiGreeceUnknown status
Policlinico Sant'Orsola-Malpighi
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BolognaItalyUnknown status
Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
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CastrovillariItalyUnknown status
Ospedale Vito Fazzi Lecce
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LecceItalyUnknown status
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
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MilanItalyUnknown status
Presidio Ospedaliero Centrale - SS. Annunziata
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TarantoItalyUnknown status
Azienda ospedaleria Santa Maria della Misericordia di Udine
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UdineItalyUnknown status
Hospital Da Senhora Da Oliveira Guimarăes
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GuimarãesPortugalUnknown status
Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
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LisbonPortugalUnknown status
Centro Hospitalar Universitário de São João
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PortoPortugalUnknown status
Hospital Distrital de Santarém
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SantarémPortugalUnknown status
Národný ústav srdcových a cievnych chorôb, a.s. (NÚSCH, a.s.)
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BratislavaSlovakiaUnknown status
Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
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AkronUnited StatesUnknown status
Phoebe Putney Memorial Hospital
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AlbanyUnited StatesUnknown status
Presbyterian Heart Group
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AlbuquerqueUnited StatesUnknown status
Alaska Heart
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AnchorageUnited StatesUnknown status
Texas Cardiac Arrhythmia Research Foundation
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AustinUnited StatesUnknown status
MedStar Health Research Institute
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BaltimoreUnited StatesUnknown status
Our Lady of the Lake Office of Research
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Baton RougeUnited StatesUnknown status
South Shore University Hospital
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Bay ShoreUnited StatesUnknown status
St. Luke's University Health Network
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BethlehemUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Brigham & Women's Hospital (Boston, MA)
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BostonUnited StatesUnknown status
Southwest EP
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ChandlerUnited StatesUnknown status
Chula Vista Cardiac Center
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Chula VistaUnited StatesUnknown status
The Christ Hospital Health Network
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CincinnatiUnited StatesUnknown status
University of Cincinnati
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CincinnatiUnited StatesUnknown status
Clearwater Cardiovascular Consultants
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ClearwaterUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
Colorado Springs Cardiology
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Colorado SpringsUnited StatesUnknown status
Missouri Cardiovascular Specialists
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ColumbiaUnited StatesUnknown status
University Hospital of Missouri
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ColumbiaUnited StatesUnknown status
Geisinger Medical Center
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DanvilleUnited StatesUnknown status
Denver Heart
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DenverUnited StatesUnknown status
Duke University Medical Center (DUMC)
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DurhamUnited StatesUnknown status
Saint Elizabeth Healthcare
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EdgewoodUnited StatesUnknown status
UPMC Heart and Vascular Institute at UPMC Hamot
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ErieUnited StatesUnknown status
Deaconess Specialty Physicians
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EvansvilleUnited StatesUnknown status
Consultants in Cardiology
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Fort WorthUnited StatesUnknown status
Heart Center of North Texas
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Fort WorthUnited StatesUnknown status
Hartford Hospital
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HartfordUnited StatesUnknown status
Heart Rhythm Solutions
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HollywoodUnited StatesUnknown status
Huntington Hospital
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HuntingtonUnited StatesUnknown status
Baptist Health
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JacksonvilleUnited StatesUnknown status
Cardiology Associates of Northeast Arkansas
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JonesboroUnited StatesUnknown status
Kansas University Medical Center
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Kansas CityUnited StatesUnknown status
Saint Lukes Health System
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Kansas CityUnited StatesUnknown status
Colorado Heart and Vascular
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LakewoodUnited StatesUnknown status
Sparrow Clinical Research Institute
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LansingUnited StatesUnknown status
Saint Vincent Heart Clinic Arkansas
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Little RockUnited StatesUnknown status
Norton Heart Specialists
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LouisvilleUnited StatesUnknown status
North Shore University Hospital
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ManhassetUnited StatesUnknown status
UP Health System Marquette
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MarquetteUnited StatesUnknown status
Aurora Cardiovascular Services
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MilwaukeeUnited StatesUnknown status
Northern Westchester Hospital
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Mount KiscoUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Saint Thomas Research Institute
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NashvilleUnited StatesUnknown status
Yale New Haven Hospital
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New HavenUnited StatesUnknown status
Long Island Jewish Medical Center
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New Hyde ParkUnited StatesUnknown status
New York Presbyterian Hospital-Columbia University Medical Center
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New YorkUnited StatesUnknown status
Lenox Hill Hospital
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New YorkUnited StatesUnknown status
New York-Presbyterian Hospital/Weill Cornell Medical Center
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New YorkUnited StatesUnknown status
Monmouth Cardiology Associates
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Ocean CityUnited StatesUnknown status
Nebraska Medicine
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OmahaUnited StatesUnknown status
Cardiovascular Institute of Northwest Florida
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Panama CityUnited StatesUnknown status
Hudson Valley Heart Center
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PoughkeepsieUnited StatesUnknown status
WakeMed Health & Hospitals
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RaleighUnited StatesUnknown status
North Memorial Heart and Vascular Institute
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RobbinsdaleUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
Heart & Vascular Institute of Florida
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Safety HarborUnited StatesUnknown status
Tidal Health Peninsula Regional
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SalisburyUnited StatesUnknown status
San Diego Arrhythmia Associates
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San DiegoUnited StatesUnknown status
Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
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SarasotaUnited StatesUnknown status
Associates in Cardiology PA
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Silver SpringUnited StatesUnknown status
Kootenai Heart Clinics Northwest
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SpokaneUnited StatesUnknown status
Staten Island University Hospital
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Staten IslandUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status
EP Heart
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The WoodlandsUnited StatesUnknown status
COR Healthcare
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TorranceUnited StatesUnknown status
Cardiovascular Consultants Medical Group (Van Nuys)
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Van NuysUnited StatesUnknown status
Cardiology Associates Medical Group
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VenturaUnited StatesUnknown status
Iowa Heart Center
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West Des MoinesUnited StatesUnknown status
Geisinger Wyoming Valley Medical Center
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Wilkes-BarreUnited StatesUnknown status
Michigan Heart
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YpsilantiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.