Personalized Therapy Study - Attain Stability Quad Post-Approval Study

NCT ID: NCT04024943

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1092 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-21

Study Completion Date

2028-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Attain Stability Quad (ASQ) PAS is a multi-center, single arm, prospective observational study. However, in the US, retrospective enrollments from participants in the IDE study (IDE #G170020) are allowed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Medtronic CRT-P Medtronic CRT-D

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medtronic

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alaska Heart

Anchorage, Alaska, United States

Site Status

Southwest EP

Chandler, Arizona, United States

Site Status

Cardiology Associates of Northeast Arkansas

Jonesboro, Arkansas, United States

Site Status

Saint Vincent Heart Clinic Arkansas

Little Rock, Arkansas, United States

Site Status

Chula Vista Cardiac Center

Chula Vista, California, United States

Site Status

San Diego Arrhythmia Associates

San Diego, California, United States

Site Status

COR Healthcare

Torrance, California, United States

Site Status

Cardiovascular Consultants Medical Group (Van Nuys)

Van Nuys, California, United States

Site Status

Cardiology Associates Medical Group

Ventura, California, United States

Site Status

Colorado Springs Cardiology

Colorado Springs, Colorado, United States

Site Status

Denver Heart

Denver, Colorado, United States

Site Status

Colorado Heart and Vascular

Lakewood, Colorado, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

Clearwater Cardiovascular Consultants

Clearwater, Florida, United States

Site Status

Heart Rhythm Solutions

Hollywood, Florida, United States

Site Status

Baptist Health

Jacksonville, Florida, United States

Site Status

Cardiovascular Institute of Northwest Florida

Panama City, Florida, United States

Site Status

Heart & Vascular Institute of Florida

Safety Harbor, Florida, United States

Site Status

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

Sarasota, Florida, United States

Site Status

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Site Status

Deaconess Specialty Physicians

Evansville, Indiana, United States

Site Status

Iowa Heart Center

West Des Moines, Iowa, United States

Site Status

Kansas University Medical Center

Kansas City, Kansas, United States

Site Status

Saint Elizabeth Healthcare

Edgewood, Kentucky, United States

Site Status

Norton Heart Specialists

Louisville, Kentucky, United States

Site Status

Our Lady of the Lake Office of Research

Baton Rouge, Louisiana, United States

Site Status

MedStar Health Research Institute

Baltimore, Maryland, United States

Site Status

Tidal Health Peninsula Regional

Salisbury, Maryland, United States

Site Status

Associates in Cardiology PA

Silver Spring, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Brigham & Women's Hospital (Boston, MA)

Boston, Massachusetts, United States

Site Status

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Site Status

UP Health System - Marquette

Marquette, Michigan, United States

Site Status

Michigan Heart

Ypsilanti, Michigan, United States

Site Status

North Memorial Heart and Vascular Institute

Robbinsdale, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Missouri Cardiovascular Specialists

Columbia, Missouri, United States

Site Status

University Hospital of Missouri

Columbia, Missouri, United States

Site Status

Saint Lukes Health System

Kansas City, Missouri, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Nebraska Medicine

Omaha, Nebraska, United States

Site Status

Monmouth Cardiology Associates

Ocean City, New Jersey, United States

Site Status

Presbyterian Heart Group

Albuquerque, New Mexico, United States

Site Status

South Shore University Hospital

Bay Shore, New York, United States

Site Status

Huntington Hospital

Huntington, New York, United States

Site Status

North Shore University Hospital

Manhasset, New York, United States

Site Status

Northern Westchester Hospital

Mount Kisco, New York, United States

Site Status

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, United States

Site Status

New York-Presbyterian Hospital/Columbia University Medical Center

New York, New York, United States

Site Status

Lenox Hill Hospital

New York, New York, United States

Site Status

Hudson Valley Heart Center

Poughkeepsie, New York, United States

Site Status

Staten Island University Hospital

Staten Island, New York, United States

Site Status

Duke University Medical Center (DUMC)

Durham, North Carolina, United States

Site Status

WakeMed Health & Hospitals

Raleigh, North Carolina, United States

Site Status

Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

Akron, Ohio, United States

Site Status

The Christ Hospital Health Network

Cincinnati, Ohio, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

UPMC Heart and Vascular Institute at UPMC Hamot

Erie, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, United States

Site Status

Saint Thomas Research Institute

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Site Status

Heart Center of North Texas

Fort Worth, Texas, United States

Site Status

Consultants in Cardiology

Fort Worth, Texas, United States

Site Status

EP Heart

The Woodlands, Texas, United States

Site Status

Kootenai Heart Clinics Northwest

Spokane, Washington, United States

Site Status

Aurora Cardiovascular Services

Milwaukee, Wisconsin, United States

Site Status

Clinique Rhône Durance

Avignon, , France

Site Status

Centre Hospitalier de la Côte Basque

Bayonne, , France

Site Status

CHRU Brest - Hôpital de la Cavale Blanche

Brest, , France

Site Status

Générale de Santé - Hôpital Privé Saint Martin

Caen, , France

Site Status

CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol

Caen, , France

Site Status

CHU de Clermont Ferrand

Clermont-Ferrand, , France

Site Status

CHU de Dijon - Hospital Le Bocage

Dijon, , France

Site Status

CHRU La Rochelle

La Rochelle, , France

Site Status

Hopital prive Clairval - Ramsay Sante

Marseille, , France

Site Status

Nouvelles Cliniques Nantaises

Nantes, , France

Site Status

Centre hospitalier de la région d'Annecy

Pringy, , France

Site Status

Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord

Saint-Priest-en-Jarez, , France

Site Status

Capio - Clinique du Tonkin

Villeurbanne, , France

Site Status

Hygeia Hospital

Athens, , Greece

Site Status

Athens Medical Center

Marousi, , Greece

Site Status

Policlinico Sant' Orsola - Malpighi

Bologna, , Italy

Site Status

Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"

Castrovillari, , Italy

Site Status

Ospedale "Vito Fazzi" Lecce

Lecce, , Italy

Site Status

Azienda Ospedaliera Ospedale Niguarda Ca Granda

Milan, , Italy

Site Status

Presidio Ospedaliero Centrale - SS. Annunziata

Taranto, , Italy

Site Status

Azienda ospedaleria Santa Maria della Misericordia di Udine

Udine, , Italy

Site Status

Hospital da Senhora da Oliveira - Guimarães

Guimarães, , Portugal

Site Status

Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

Lisbon, , Portugal

Site Status

Centro Hospitalar Universitário de São João

Porto, , Portugal

Site Status

Hospital Distrital de Santarém

Santarém, , Portugal

Site Status

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

Bratislava, , Slovakia

Site Status

Hospital Universitario da Coruna

A Coruña, , Spain

Site Status

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Site Status

Hospital Universitario Clínico San Cecilio

Granada, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Complejo Universitario de Salamanca

Salamanca, , Spain

Site Status

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, , Spain

Site Status

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, , Spain

Site Status

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Site Status

Cardiopark Zurich

Zurich, , Switzerland

Site Status

University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

Birmingham, , United Kingdom

Site Status

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

Blackpool, , United Kingdom

Site Status

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, , United Kingdom

Site Status

Imperial College Healthcare NHS Trust - Hammersmith Hospital

London, , United Kingdom

Site Status

Central Manchester University Hospitals NHS - Manchester Royal Infirmary

Manchester, , United Kingdom

Site Status

The James Cook University Hospital - South Tees Hospitals NHS

Middlesbrough, , United Kingdom

Site Status

Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General

Sheffield, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States France Greece Italy Portugal Slovakia Spain Switzerland United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Attain Stability Quad PAS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CONVERGE Post-Approval Study (PAS)
NCT05393180 ACTIVE_NOT_RECRUITING NA
PULSED AF Post-Approval Study
NCT06578104 RECRUITING
LEAF - Low Energy In Atrial Fibrillation
NCT00157781 COMPLETED PHASE4