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ACTIVE NOT RECRUITING
NCT04024943

Personalized Therapy Study - Attain Stability Quad Post-Approval Study

Sponsor: Medtronic

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

1092

Start Date

2017-08-21

Completion Date

2028-01

Last Updated

2026-02-04

Healthy Volunteers

No

Conditions

Interventions

DEVICE

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.

Locations (115)

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

Cardiovascular Consultants Medical Group (Van Nuys)

Van Nuys, California, United States

Cardiology Associates Medical Group

Ventura, California, United States

Colorado Springs Cardiology

Colorado Springs, Colorado, United States

Denver Heart

Denver, Colorado, United States

Colorado Heart and Vascular

Lakewood, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Clearwater Cardiovascular Consultants

Clearwater, Florida, United States

Heart Rhythm Solutions

Hollywood, Florida, United States

Baptist Health

Jacksonville, Florida, United States

Cardiovascular Institute of Northwest Florida

Panama City, Florida, United States

Heart & Vascular Institute of Florida

Safety Harbor, Florida, United States

Heart Rhythm Consultants P.A. (Sarasota Memorial Research)

Sarasota, Florida, United States

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Deaconess Specialty Physicians

Evansville, Indiana, United States

Iowa Heart Center

West Des Moines, Iowa, United States

Kansas University Medical Center

Kansas City, Kansas, United States

Saint Elizabeth Healthcare

Edgewood, Kentucky, United States

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

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

University Hospital of Missouri

Columbia, Missouri, United States

Saint Lukes Health System

Kansas City, Missouri, United States

Washington University

St Louis, Missouri, United States

Nebraska Medicine

Omaha, Nebraska, United States

Monmouth Cardiology Associates

Ocean City, New Jersey, United States

Presbyterian Heart Group

Albuquerque, New Mexico, United States

South Shore University Hospital

Bay Shore, New York, United States

Huntington Hospital

Huntington, New York, United States

North Shore University Hospital

Manhasset, New York, United States

Northern Westchester Hospital

Mount Kisco, New York, United States

Long Island Jewish Medical Center

New Hyde Park, New York, United States

New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, United States

New York-Presbyterian Hospital/Columbia University Medical Center

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

Hudson Valley Heart Center

Poughkeepsie, New York, United States

Staten Island University Hospital

Staten Island, New York, United States

Duke University Medical Center (DUMC)

Durham, North Carolina, United States

WakeMed Health & Hospitals

Raleigh, North Carolina, United States

Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

Akron, Ohio, United States

The Christ Hospital Health Network

Cincinnati, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

UPMC Heart and Vascular Institute at UPMC Hamot

Erie, Pennsylvania, United States

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, United States

Saint Thomas Research Institute

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Heart Center of North Texas

Fort Worth, Texas, United States

Consultants in Cardiology

Fort Worth, Texas, United States

EP Heart

The Woodlands, Texas, United States

Kootenai Heart Clinics Northwest

Spokane, Washington, United States

Aurora Cardiovascular Services

Milwaukee, Wisconsin, United States

Clinique Rhône Durance

Avignon, France

Centre Hospitalier de la Côte Basque

Bayonne, France

CHRU Brest - Hôpital de la Cavale Blanche

Brest, France

Générale de Santé - Hôpital Privé Saint Martin

Caen, France

CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol

Caen, France

CHU de Clermont Ferrand

Clermont-Ferrand, France

CHU de Dijon - Hospital Le Bocage

Dijon, France

CHRU La Rochelle

La Rochelle, France

Hopital prive Clairval - Ramsay Sante

Marseille, France

Nouvelles Cliniques Nantaises

Nantes, France

Centre hospitalier de la région d'Annecy

Pringy, France

Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord

Saint-Priest-en-Jarez, France

Capio - Clinique du Tonkin

Villeurbanne, France

Hygeia Hospital

Athens, Greece

Athens Medical Center

Marousi, Greece

Policlinico Sant' Orsola - Malpighi

Bologna, Italy

Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"

Castrovillari, Italy

Ospedale "Vito Fazzi" Lecce

Lecce, Italy

Azienda Ospedaliera Ospedale Niguarda Ca Granda

Milan, Italy

Presidio Ospedaliero Centrale - SS. Annunziata

Taranto, Italy

Azienda ospedaleria Santa Maria della Misericordia di Udine

Udine, Italy

Hospital da Senhora da Oliveira - Guimarães

Guimarães, Portugal

Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

Lisbon, Portugal

Centro Hospitalar Universitário de São João

Porto, Portugal

Hospital Distrital de Santarém

Santarém, Portugal

Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)

Bratislava, Slovakia

Hospital Universitario da Coruna

A Coruña, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Hospital Universitario Clínico San Cecilio

Granada, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Complejo Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Spain

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Cardiopark Zurich

Zurich, Switzerland

University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

Birmingham, United Kingdom

Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital

Blackpool, United Kingdom

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, United Kingdom

Imperial College Healthcare NHS Trust - Hammersmith Hospital

London, United Kingdom

Central Manchester University Hospitals NHS - Manchester Royal Infirmary

Manchester, United Kingdom

The James Cook University Hospital - South Tees Hospitals NHS

Middlesbrough, United Kingdom

Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General

Sheffield, United Kingdom