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Heart FailureASQNCT04024943

Personalized Therapy Study - Attain Stability Quad Post-Approval Study

An observational study of Heart Failure, run by Medtronic at 115 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Heart Failure
What is being tested?
Quadripolar LV Lead
Type of treatment
Medical device
How many people
1,092 participants
Where
115 sitesin 9 countries
Study dates
21 Aug 2017to Jan 2028
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

115 sites in 9 countries.

115 sites in 9 countries

United States72 sites

  • Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

    Akron, Ohio, 44304-1473

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701-1943

  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106-4921

  • Alaska Heart

    Anchorage, Alaska, 99508-4673

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705-1852

  • MedStar Health Research Institute

    Baltimore, Maryland, 21237-3958

  • Our Lady of the Lake Office of Research

    Baton Rouge, Louisiana, 70808

  • South Shore University Hospital

    Bay Shore, New York, 11706

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, 18015-1155

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114-2621

  • Brigham & Women's Hospital (Boston, MA)

    Boston, Massachusetts, 02115-6110

  • Southwest EP

    Chandler, Arizona, 85295-1680

  • Chula Vista Cardiac Center

    Chula Vista, California, 91910

  • The Christ Hospital Health Network

    Cincinnati, Ohio, 45219

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0542

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756-3356

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Colorado Springs Cardiology

    Colorado Springs, Colorado, 80907

  • Missouri Cardiovascular Specialists

    Columbia, Missouri, 65201-8023

  • University Hospital of Missouri

    Columbia, Missouri, 65212

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Denver Heart

    Denver, Colorado, 80220-3918

  • Duke University Medical Center (DUMC)

    Durham, North Carolina, 27705

  • Saint Elizabeth Healthcare

    Edgewood, Kentucky, 41017

  • UPMC Heart and Vascular Institute at UPMC Hamot

    Erie, Pennsylvania, 16507-1579

  • Deaconess Specialty Physicians

    Evansville, Indiana, 47710

  • Heart Center of North Texas

    Fort Worth, Texas, 761014

  • Consultants in Cardiology

    Fort Worth, Texas, 76104-2821

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Heart Rhythm Solutions

    Hollywood, Florida, 33021

  • Huntington Hospital

    Huntington, New York, 11743

  • Baptist Health

    Jacksonville, Florida, 32207

  • Cardiology Associates of Northeast Arkansas

    Jonesboro, Arkansas, 72410-4163

  • Kansas University Medical Center

    Kansas City, Kansas, 66160-8500

  • Saint Lukes Health System

    Kansas City, Missouri, 64111-5934

  • Colorado Heart and Vascular

    Lakewood, Colorado, 80228

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

  • Saint Vincent Heart Clinic Arkansas

    Little Rock, Arkansas, 72205-6202

  • Norton Heart Specialists

    Louisville, Kentucky, 40205-3373

  • North Shore University Hospital

    Manhasset, New York, 11030

  • UP Health System - Marquette

    Marquette, Michigan, 49855-2705

  • Aurora Cardiovascular Services

    Milwaukee, Wisconsin, 53215

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

  • Saint Thomas Research Institute

    Nashville, Tennessee, 37205-2018

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-8802

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520-8017

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • New York-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York, 10021

  • New York-Presbyterian Hospital/Columbia University Medical Center

    New York, New York, 10032

  • Lenox Hill Hospital

    New York, New York, 10075

  • Monmouth Cardiology Associates

    Ocean City, New Jersey, 07712-4762

  • Nebraska Medicine

    Omaha, Nebraska, 68105

  • Cardiovascular Institute of Northwest Florida

    Panama City, Florida, 32405

  • Hudson Valley Heart Center

    Poughkeepsie, New York, 12601-3923

  • WakeMed Health & Hospitals

    Raleigh, North Carolina, 27610

  • North Memorial Heart and Vascular Institute

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Heart & Vascular Institute of Florida

    Safety Harbor, Florida, 34695-6604

  • Tidal Health Peninsula Regional

    Salisbury, Maryland, 21804-6938

  • San Diego Arrhythmia Associates

    San Diego, California, 92103

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

    Sarasota, Florida, 34233

  • Associates in Cardiology PA

    Silver Spring, Maryland, 20910-1265

  • Kootenai Heart Clinics Northwest

    Spokane, Washington, 99204-2352

  • Washington University

    St Louis, Missouri, 63110-1010

  • Staten Island University Hospital

    Staten Island, New York, 10305-3436

  • EP Heart

    The Woodlands, Texas, 77384

  • COR Healthcare

    Torrance, California, 90505

  • Cardiovascular Consultants Medical Group (Van Nuys)

    Van Nuys, California, 91405-3646

  • Cardiology Associates Medical Group

    Ventura, California, 93003

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

  • Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • Michigan Heart

    Ypsilanti, Michigan, 48197-8633

Other trials in United States

France13 sites

  • Clinique Rhône Durance

    Avignon, 84082

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64109

  • CHRU Brest - Hôpital de la Cavale Blanche

    Brest, 29609

  • Générale de Santé - Hôpital Privé Saint Martin

    Caen, 14000

  • CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol

    Caen, 14033

  • CHU de Clermont Ferrand

    Clermont-Ferrand, 63003

  • CHU de Dijon - Hospital Le Bocage

    Dijon, 21079

  • CHRU La Rochelle

    La Rochelle, 17019

  • Hopital prive Clairval - Ramsay Sante

    Marseille, 13009

  • Nouvelles Cliniques Nantaises

    Nantes

  • Centre hospitalier de la région d'Annecy

    Pringy, 74374

  • Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord

    Saint-Priest-en-Jarez, 42270

  • Capio - Clinique du Tonkin

    Villeurbanne, 69100

Other trials in France

Spain8 sites

  • Hospital Universitario da Coruna

    A Coruña, 15006

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital Universitario Clínico San Cecilio

    Granada

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Complejo Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, 38010

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47006

Other trials in Spain

United Kingdom7 sites

  • University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

    Birmingham

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

    Blackpool

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool

  • Imperial College Healthcare NHS Trust - Hammersmith Hospital

    London

  • Central Manchester University Hospitals NHS - Manchester Royal Infirmary

    Manchester

  • The James Cook University Hospital - South Tees Hospitals NHS

    Middlesbrough

  • Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General

    Sheffield

Other trials in United Kingdom

Italy6 sites

  • Policlinico Sant' Orsola - Malpighi

    Bologna, 40138

  • Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"

    Castrovillari, 87012

  • Ospedale "Vito Fazzi" Lecce

    Lecce, 73100

  • Azienda Ospedaliera Ospedale Niguarda Ca Granda

    Milan, 20162

  • Presidio Ospedaliero Centrale - SS. Annunziata

    Taranto, 74024

  • Azienda ospedaleria Santa Maria della Misericordia di Udine

    Udine

Other trials in Italy

Portugal4 sites

  • Hospital da Senhora da Oliveira - Guimarães

    Guimarães, 4835-044

  • Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

    Lisbon, 1649-035

  • Centro Hospitalar Universitário de São João

    Porto, 4200-319

  • Hospital Distrital de Santarém

    Santarém, 2000-177

Other trials in Portugal

Greece2 sites

  • Hygeia Hospital

    Athens, 15123

  • Athens Medical Center

    Marousi, 15125

Other trials in Greece

Switzerland2 sites

  • Hôpitaux Universitaires de Genève

    Geneva, 1205

  • Cardiopark Zurich

    Zurich, 8027

Other trials in Switzerland

Slovakia1 site

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

    Bratislava

Other trials in Slovakia

About this study

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).

Read the 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.

Conditions
Heart Failure
Being tested
Quadripolar LV Lead
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quadripolar LV LeadDevice

    Also called Medtronic CRT-P, Medtronic CRT-D

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients without a lead- related event at 5 years post-implant

    To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for Attain Stability Quad LV leads.

    Measured: 5 years

Secondary outcomes (2)

  1. Number of lead-related adverse device effects

    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

    Measured: 5 years

  2. Number of explanted leads that have been returned

    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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2019
  2. Study start21 Aug 2017
  3. Primary completionJul 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,092 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04024943
Sponsor's protocol ID
Attain Stability Quad PAS
Acronym
ASQ
Status last verified
Jan 2026
First submitted
24 Jun 2019
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Yee R, Love CJ, Kaiser DW, Birgersdotter-Green U, Cha YM, Singh JP, Liu S, Zhang Y, Chung ES. Rationale and Design of the Personalized Therapy Study: Evaluating Real-World Performance of Two Automated Defibrillation Therapy Algorithms. J Card Fail. 2025 May;31(5):824-832. doi: 10.1016/j.cardfail.2024.11.011. Epub 2024 Dec 16.

    PubMed 39694452

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Medtronic at 115 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, France, Spain, United Kingdom, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients without a lead- related event at 5 years post-implant (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04024943, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.

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