Personalized Therapy Study - Attain Stability Quad Post-Approval Study

Running, not enrolling

Conditions studied: Heart Failure

In brief

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).

Key facts

Study ID

NCT04024943

Run by

Medtronic

People needed

1092

Starts

2017-08-21

Expected to finish

2028-01-01

Last updated by the study team

2026-02-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Norton Heart Specialists — Louisville, Kentucky, United States
• Our Lady of the Lake Office of Research — Baton Rouge, Louisiana, United States
• MedStar Health Research Institute — Baltimore, Maryland, United States
• Tidal Health Peninsula Regional — Salisbury, Maryland, United States
• Associates in Cardiology PA — Silver Spring, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Capio - Clinique du Tonkin — Villeurbanne, France
• Hygeia Hospital — Athens, Greece
• Athens Medical Center — Marousi, Greece
• Policlinico Sant' Orsola - Malpighi — Bologna, Italy
• Alaska Heart — Anchorage, Alaska, United States
• Southwest EP — Chandler, Arizona, United States
• Cardiology Associates of Northeast Arkansas — Jonesboro, Arkansas, United States
• Saint Vincent Heart Clinic Arkansas — Little Rock, Arkansas, United States
• Chula Vista Cardiac Center — Chula Vista, California, United States
• San Diego Arrhythmia Associates — San Diego, California, United States
• COR Healthcare — Torrance, California, United States
• Brigham & Women's Hospital (Boston, MA) — Boston, Massachusetts, United States
• Sparrow Clinical Research Institute — Lansing, Michigan, United States
• UP Health System - Marquette — Marquette, Michigan, United States
• Michigan Heart — Ypsilanti, Michigan, United States
• North Memorial Heart and Vascular Institute — Robbinsdale, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Missouri Cardiovascular Specialists — Columbia, Missouri, United States
• Saint Elizabeth Healthcare — Edgewood, Kentucky, United States

Full record on ClinicalTrials.gov

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