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
- Diseases
- Heart failure
- 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
Sites (115)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpitaux universitaires de Genève Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Cardiopark Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Hospital Universitario da Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Complejo Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Hospital Universitario Nuestra Señora de Candelaria Coordinator of this site? Confirm its status | Santa Cruz de Tenerife | Spain | Unknown status |
| Complejo Hospitalario Universitario De Santiago De Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
| Clinique Rhône Durance Coordinator of this site? Confirm its status | Avignon | France | Unknown status |
| Centre Hospitalier de la Cote Basque Coordinator of this site? Confirm its status | Bayonne | France | Unknown status |
| CHRU Brest - Hôpital de la Cavale Blanche Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Générale de Santé - Hôpital Privé Saint Martin Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| CHU de Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| CHU de Dijon - Hospital Le Bocage Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHRU La Rochelle Coordinator of this site? Confirm its status | La Rochelle | France | Unknown status |
| Hopital prive Clairval - Ramsay Sante Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Nouvelles Cliniques Nantaises Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Centre Hospitalier de la Région d'Annecy Coordinator of this site? Confirm its status | PRINGY | France | Unknown status |
| Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Unknown status |
| Capio - Clinique du Tonkin Coordinator of this site? Confirm its status | Villeurbanne | France | Unknown status |
| University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital Coordinator of this site? Confirm its status | Blackpool | United Kingdom | Unknown status |
| Liverpool Heart and Chest Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Imperial College Healthcare Nhs Trust - Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Central Manchester University Hospitals NHS - Manchester Royal Infirmary Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| The James Cook University Hospital - South Tees Hospitals NHS Coordinator of this site? Confirm its status | Middlesbrough | United Kingdom | Unknown status |
| Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| HYGEIA Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Athens Medical Center Coordinator of this site? Confirm its status | Marousi | Greece | Unknown status |
| Policlinico Sant'Orsola-Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari" Coordinator of this site? Confirm its status | Castrovillari | Italy | Unknown status |
| Ospedale Vito Fazzi Lecce Coordinator of this site? Confirm its status | Lecce | Italy | Unknown status |
| Azienda Ospedaliera Ospedale Niguarda Ca' Granda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Presidio Ospedaliero Centrale - SS. Annunziata Coordinator of this site? Confirm its status | Taranto | Italy | Unknown status |
| Azienda ospedaleria Santa Maria della Misericordia di Udine Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
| Hospital Da Senhora Da Oliveira Guimarăes Coordinator of this site? Confirm its status | Guimarães | Portugal | Unknown status |
| Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Centro Hospitalar Universitário de São João Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Hospital Distrital de Santarém Coordinator of this site? Confirm its status | Santarém | Portugal | Unknown status |
| Národný ústav srdcových a cievnych chorôb, a.s. (NÚSCH, a.s.) Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
| Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists Coordinator of this site? Confirm its status | Akron | United States | Unknown status |
| Phoebe Putney Memorial Hospital Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Presbyterian Heart Group Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Alaska Heart Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| Texas Cardiac Arrhythmia Research Foundation Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| MedStar Health Research Institute Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Our Lady of the Lake Office of Research Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| South Shore University Hospital Coordinator of this site? Confirm its status | Bay Shore | United States | Unknown status |
| St. Luke's University Health Network Coordinator of this site? Confirm its status | Bethlehem | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Brigham & Women's Hospital (Boston, MA) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Southwest EP Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| Chula Vista Cardiac Center Coordinator of this site? Confirm its status | Chula Vista | United States | Unknown status |
| The Christ Hospital Health Network Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Clearwater Cardiovascular Consultants Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Colorado Springs Cardiology Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Missouri Cardiovascular Specialists Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| University Hospital of Missouri Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Geisinger Medical Center Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Denver Heart Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Duke University Medical Center (DUMC) Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Saint Elizabeth Healthcare Coordinator of this site? Confirm its status | Edgewood | United States | Unknown status |
| UPMC Heart and Vascular Institute at UPMC Hamot Coordinator of this site? Confirm its status | Erie | United States | Unknown status |
| Deaconess Specialty Physicians Coordinator of this site? Confirm its status | Evansville | United States | Unknown status |
| Consultants in Cardiology Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Heart Center of North Texas Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Hartford Hospital Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| Heart Rhythm Solutions Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Huntington Hospital Coordinator of this site? Confirm its status | Huntington | United States | Unknown status |
| Baptist Health Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Cardiology Associates of Northeast Arkansas Coordinator of this site? Confirm its status | Jonesboro | United States | Unknown status |
| Kansas University Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Saint Lukes Health System Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Colorado Heart and Vascular Coordinator of this site? Confirm its status | Lakewood | United States | Unknown status |
| Sparrow Clinical Research Institute Coordinator of this site? Confirm its status | Lansing | United States | Unknown status |
| Saint Vincent Heart Clinic Arkansas Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Norton Heart Specialists Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| North Shore University Hospital Coordinator of this site? Confirm its status | Manhasset | United States | Unknown status |
| UP Health System Marquette Coordinator of this site? Confirm its status | Marquette | United States | Unknown status |
| Aurora Cardiovascular Services Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Northern Westchester Hospital Coordinator of this site? Confirm its status | Mount Kisco | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Saint Thomas Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Long Island Jewish Medical Center Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| New York Presbyterian Hospital-Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Lenox Hill Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| New York-Presbyterian Hospital/Weill Cornell Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Monmouth Cardiology Associates Coordinator of this site? Confirm its status | Ocean City | United States | Unknown status |
| Nebraska Medicine Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Cardiovascular Institute of Northwest Florida Coordinator of this site? Confirm its status | Panama City | United States | Unknown status |
| Hudson Valley Heart Center Coordinator of this site? Confirm its status | Poughkeepsie | United States | Unknown status |
| WakeMed Health & Hospitals Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| North Memorial Heart and Vascular Institute Coordinator of this site? Confirm its status | Robbinsdale | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Heart & Vascular Institute of Florida Coordinator of this site? Confirm its status | Safety Harbor | United States | Unknown status |
| Tidal Health Peninsula Regional Coordinator of this site? Confirm its status | Salisbury | United States | Unknown status |
| San Diego Arrhythmia Associates Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Heart Rhythm Consultants P.A. (Sarasota Memorial Research) Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Associates in Cardiology PA Coordinator of this site? Confirm its status | Silver Spring | United States | Unknown status |
| Kootenai Heart Clinics Northwest Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Staten Island University Hospital Coordinator of this site? Confirm its status | Staten Island | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| EP Heart Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| COR Healthcare Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| Cardiovascular Consultants Medical Group (Van Nuys) Coordinator of this site? Confirm its status | Van Nuys | United States | Unknown status |
| Cardiology Associates Medical Group Coordinator of this site? Confirm its status | Ventura | United States | Unknown status |
| Iowa Heart Center Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
| Geisinger Wyoming Valley Medical Center Coordinator of this site? Confirm its status | Wilkes-Barre | United States | Unknown status |
| Michigan Heart Coordinator of this site? Confirm its status | Ypsilanti | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.