Personalized Therapy Study - Attain Stability Quad Post-Approval Study

NCT04024943 · tracked via the Priya Life Science UK tracker

Sponsor

Medtronic

Phase

Observational

Started

2017-08-21

Last updated

2026-02-04

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Quadripolar LV Lead

Quadripolar LV Lead: The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is an active fixation quadripolar LV lead based on the Attain Performa lead family models (4298, 4398, and 4598). The lead incorporates an active fixation helix similar to the OUS commercialized Attain Stability bipolar LV lead (Model 20066/4796) which is designed to allow an implanter more options in lead location.

Study 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).

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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 outcome measure(s)

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.

Trial sites (115)

Facility	City	Region
Alaska Heart	Anchorage	Alaska
Southwest EP	Chandler	Arizona
Cardiology Associates of Northeast Arkansas	Jonesboro	Arkansas
Saint Vincent Heart Clinic Arkansas	Little Rock	Arkansas
Chula Vista Cardiac Center	Chula Vista	California
San Diego Arrhythmia Associates	San Diego	California
COR Healthcare	Torrance	California
Cardiovascular Consultants Medical Group (Van Nuys)	Van Nuys	California
Cardiology Associates Medical Group	Ventura	California
Colorado Springs Cardiology	Colorado Springs	Colorado
Denver Heart	Denver	Colorado
Colorado Heart and Vascular	Lakewood	Colorado
Hartford Hospital	Hartford	Connecticut
Yale New Haven Hospital	New Haven	Connecticut
Clearwater Cardiovascular Consultants	Clearwater	Florida
Heart Rhythm Solutions	Hollywood	Florida
Baptist Health	Jacksonville	Florida
Cardiovascular Institute of Northwest Florida	Panama City	Florida
Heart & Vascular Institute of Florida	Safety Harbor	Florida
Heart Rhythm Consultants P.A. (Sarasota Memorial Research)	Sarasota	Florida
Phoebe Putney Memorial Hospital	Albany	Georgia
Deaconess Specialty Physicians	Evansville	Indiana
Iowa Heart Center	West Des Moines	Iowa
Kansas University Medical Center	Kansas City	Kansas
Saint Elizabeth Healthcare	Edgewood	Kentucky
Norton Heart Specialists	Louisville	Kentucky
Our Lady of the Lake Office of Research	Baton Rouge	Louisiana
MedStar Health Research Institute	Baltimore	Maryland
Tidal Health Peninsula Regional	Salisbury	Maryland
Associates in Cardiology PA	Silver Spring	Maryland
Massachusetts General Hospital	Boston	Massachusetts
Brigham & Women's Hospital (Boston, MA)	Boston	Massachusetts
Sparrow Clinical Research Institute	Lansing	Michigan
UP Health System - Marquette	Marquette	Michigan
Michigan Heart	Ypsilanti	Michigan
North Memorial Heart and Vascular Institute	Robbinsdale	Minnesota
Mayo Clinic	Rochester	Minnesota
Missouri Cardiovascular Specialists	Columbia	Missouri
University Hospital of Missouri	Columbia	Missouri
Saint Lukes Health System	Kansas City	Missouri

+ 75 more sites — see the full list on the official registry below.

More Medtronic trials in the UK

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Personalized Therapy Study - HFRS (TriageHF) Post Approval Study Active, not recruiting

Lead Evaluation for Defibrillation and Reliability Post Approval Study Enrolling by invitation

Enlighten Study: The EV-ICD Post Approval Registry Active, not recruiting

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products Recruiting

Other trials for the same condition

Remote Monitoring and Optimization of Heart Failure Therapy Starting soon

Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk Recruiting

Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF) Active, not recruiting

Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients Active, not recruiting

A Research Study on the Effects of NNC0537-1482 in Participants With Heart Failure Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04024943 on ClinicalTrials.gov ↗ ← All trials in the UK