Personalized Therapy Study - Attain Stability Quad Post-Approval Study (ASQ)

December 4, 2023 updated by: Medtronic
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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

1008

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84082
        • Clinique Rhône Durance
      • Bayonne, France, 64109
        • Centre Hospitalier de la Côte Basque
      • Brest, France, 29609
        • CHRU Brest - Hôpital de la Cavale Blanche
      • Caen, France, 14000
        • Générale de Santé - Hôpital Privé Saint Martin
      • Caen, France, 14033
        • CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol
      • Clermont-Ferrand, France, 63003
        • CHU de Clermont Ferrand
      • Dijon, France, 21079
        • CHU de Dijon - Hospital Le Bocage
      • La Rochelle, France, 17019
        • CHRU La Rochelle
      • Marseille, France, 13009
        • Hopital prive Clairval - Ramsay Sante
      • Nantes, France
        • Nouvelles Cliniques Nantaises
      • Pringy, France, 74374
        • Centre Hospitalier de la Région d'Annecy
      • Saint Priest en Jarez, France, 42270
        • Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord
      • Villeurbanne, France, 69100
        • Capio - Clinique du Tonkin
  • Greece
      • Athens, Greece, 15123
        • Hygeia Hospital
      • Maroúsi, Greece, 15125
        • Athens Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Policlinico Sant' Orsola - Malpighi
      • Castrovillari, Italy, 87012
        • Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
      • Lecce, Italy, 73100
        • Ospedale "Vito Fazzi" Lecce
      • Milano, Italy, 20162
        • Azienda Ospedaliera Ospedale Niguarda CA Granda
      • Taranto, Italy, 74024
        • Presidio Ospedaliero Centrale - SS. Annunziata
      • Udine, Italy
        • Azienda ospedaleria Santa Maria della Misericordia di Udine
  • Portugal
      • Guimarães, Portugal, 4835-044
        • Hospital da Senhora da Oliveira - Guimarães
      • Lisboa, Portugal, 1649-035
        • Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitário de São João
      • Santarém, Portugal, 2000-177
        • Hospital Distrital de Santarém
  • Slovakia
      • Bratislava, Slovakia
        • Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)
  • Spain
      • Coruña, Spain, 15006
        • Hospital Universitario da Coruña
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Granada, Spain
        • Hospital Universitario Clinico San Cecilio
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de octubre
      • Salamanca, Spain, 37007
        • Complejo Universitario de Salamanca
      • Santiago De Compostela, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago de Compostela
      • Tenerife, Spain, 38010
        • Hospital Universitario Nuestra Señora de Candelaria
      • Valladolid, Spain, 47006
        • Hospital Clinico Universitario de Valladolid
  • Switzerland
      • Geneva, Switzerland, 1205
        • Hôpitaux Universitaires de Genève
      • Zürich, Switzerland, 8027
        • Cardiopark Zurich
  • United Kingdom
      • Birmingham, United Kingdom
        • University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
      • Blackpool, United Kingdom
        • Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital
      • Liverpool, United Kingdom
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
      • London, United Kingdom
        • Imperial College Healthcare NHS Trust - Hammersmith Hospital
      • Manchester, United Kingdom
        • Central Manchester University Hospitals NHS - Manchester Royal Infirmary
      • Middlesbrough, United Kingdom
        • The James Cook University Hospital - South Tees Hospitals NHS
      • Sheffield, United Kingdom
        • Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508-4673
        • Alaska Heart
    • Arizona
      • Chandler, Arizona, United States, 85295-1680
        • Southwest EP
    • Arkansas
      • Jonesboro, Arkansas, United States, 72410-4163
        • Cardiology Associates of Northeast Arkansas
      • Little Rock, Arkansas, United States, 72205-6202
        • Saint Vincent Heart Clinic Arkansas
    • California
      • Chula Vista, California, United States, 91910
        • Chula Vista Cardiac Center
      • San Diego, California, United States, 92103
        • San Diego Arrhythmia Associates
      • Torrance, California, United States, 90505
        • COR Healthcare
      • Van Nuys, California, United States, 91405-3646
        • Cardiovascular Consultants Medical Group (Van Nuys)
      • Ventura, California, United States, 93003
        • Cardiology Associates Medical Group
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Colorado Springs Cardiology
      • Denver, Colorado, United States, 80220-3918
        • Denver Heart
      • Lakewood, Colorado, United States, 80228
        • Colorado Heart and Vascular
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • New Haven, Connecticut, United States, 06520-8017
        • Yale New Haven Hospital
    • Florida
      • Clearwater, Florida, United States, 33756-3356
        • Clearwater Cardiovascular Consultants
      • Hollywood, Florida, United States, 33021
        • Heart Rhythm Solutions
      • Jacksonville, Florida, United States, 32207
        • Baptist Health
      • Panama City, Florida, United States, 32405
        • Cardiovascular Institute of Northwest Florida
      • Safety Harbor, Florida, United States, 34695-6604
        • Heart & Vascular Institute of Florida
      • Sarasota, Florida, United States, 34233
        • Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
    • Georgia
      • Albany, Georgia, United States, 31701-1943
        • Phoebe Putney Memorial Hospital
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Deaconess Specialty Physicians
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Kansas
      • Kansas City, Kansas, United States, 66160-8500
        • Kansas University Medical Center
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Saint Elizabeth Healthcare
      • Louisville, Kentucky, United States, 40205-3373
        • Norton Heart Specialists
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Office of Research
    • Maryland
      • Baltimore, Maryland, United States, 21237-3958
        • MedStar Health Research Institute
      • Salisbury, Maryland, United States, 21804-6938
        • Tidal Health Peninsula Regional
      • Silver Spring, Maryland, United States, 20910-1265
        • Associates in Cardiology PA
    • Massachusetts
      • Boston, Massachusetts, United States, 02114-2621
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115-6110
        • Brigham & Women's Hospital (Boston, MA)
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Clinical Research Institute
      • Marquette, Michigan, United States, 49855-2705
        • UP Health System - Marquette
      • Ypsilanti, Michigan, United States, 48197-8633
        • Michigan Heart
    • Minnesota
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Heart and Vascular Institute
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Columbia, Missouri, United States, 65201-8023
        • Missouri Cardiovascular Specialists
      • Columbia, Missouri, United States, 65212
        • University Hospital of Missouri
      • Kansas City, Missouri, United States, 64111-5934
        • Saint Lukes Health System
      • Saint Louis, Missouri, United States, 63110-1010
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Nebraska Medicine
    • New Jersey
      • Ocean City, New Jersey, United States, 07712-4762
        • Monmouth Cardiology Associates
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106-4921
        • Presbyterian Heart Group
    • New York
      • Bay Shore, New York, United States, 11706
        • South Shore University Hospital
      • Huntington, New York, United States, 11743
        • Huntington Hospital
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • Mount Kisco, New York, United States, 10549
        • Northern Westchester Hospital
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10075
        • Lenox Hill Hospital
      • New York, New York, United States, 10021
        • New York-Presbyterian Hospital/Weill Cornell Medical Center
      • New York, New York, United States, 10032
        • New York-Presbyterian Hospital/Columbia University Medical Center
      • Poughkeepsie, New York, United States, 12601-3923
        • Hudson Valley Heart Center
      • Staten Island, New York, United States, 10305-3436
        • Staten Island University Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center (DUMC)
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Health & Hospitals
    • Ohio
      • Akron, Ohio, United States, 44304-1473
        • Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
      • Cincinnati, Ohio, United States, 45267-0542
        • University of Cincinnati
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital Health Network
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015-1155
        • St. Luke's University Health Network
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Erie, Pennsylvania, United States, 16507-1579
        • UPMC Heart and Vascular Institute at UPMC Hamot
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232-8802
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37205-2018
        • Saint Thomas Research Institute
    • Texas
      • Austin, Texas, United States, 78705-1852
        • Texas Cardiac Arrhythmia Research Foundation
      • Fort Worth, Texas, United States, 761014
        • Heart Center of North Texas
      • Fort Worth, Texas, United States, 76104-2821
        • Consultants in Cardiology
      • The Woodlands, Texas, United States, 77384
        • EP Heart
    • Washington
      • Spokane, Washington, United States, 99204-2352
        • Kootenai Heart Clinics Northwest
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Cardiovascular Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population includes patients that are or will be implanted with a Model 4798 lead and a Medtronic CRT device.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients without a lead- related event at 5 years post-implant
Time Frame: 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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of lead-related adverse device effects
Time Frame: 5 years

The secondary objectives are descriptive in nature and are intended to gain additional information about the safety and performance of the Product:

• To summarize all Attain Stability Quad lead-related ADEs
5 years
Number of explanted leads that have been returned
Time Frame: 5 years

The secondary objectives are descriptive in nature and are intended to gain additional information about the safety and performance of the Product:

• To summarize analysis results from explanted and returned Attain Stability Quad leads
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2017

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

June 24, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (Actual)

July 18, 2019

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Attain Stability Quad PAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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