Personalized Therapy Study - Attain Stability Quad Post-Approval Study
ASQ
1 other identifier
observational
1,092
9 countries
115
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Longer than P75 for all trials
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 21, 2017
CompletedFirst Submitted
Initial submission to the registry
June 24, 2019
CompletedFirst Posted
Study publicly available on registry
July 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
February 4, 2026
January 1, 2026
9.9 years
June 24, 2019
February 2, 2026
Conditions
Outcome Measures
Primary Outcomes (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.
5 years
Secondary Outcomes (2)
Number of lead-related adverse device effects
5 years
Number of explanted leads that have been returned
5 years
Interventions
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.
Eligibility Criteria
The study population includes patients that are or will be implanted with a Model 4798 lead and a Medtronic CRT device.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtroniclead
Study Sites (115)
Alaska Heart
Anchorage, Alaska, 99508-4673, United States
Southwest EP
Chandler, Arizona, 85295-1680, United States
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, 72410-4163, United States
Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, 72205-6202, United States
Chula Vista Cardiac Center
Chula Vista, California, 91910, United States
San Diego Arrhythmia Associates
San Diego, California, 92103, United States
COR Healthcare
Torrance, California, 90505, United States
Cardiovascular Consultants Medical Group (Van Nuys)
Van Nuys, California, 91405-3646, United States
Cardiology Associates Medical Group
Ventura, California, 93003, United States
Colorado Springs Cardiology
Colorado Springs, Colorado, 80907, United States
Denver Heart
Denver, Colorado, 80220-3918, United States
Colorado Heart and Vascular
Lakewood, Colorado, 80228, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Yale New Haven Hospital
New Haven, Connecticut, 06520-8017, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756-3356, United States
Heart Rhythm Solutions
Hollywood, Florida, 33021, United States
Baptist Health
Jacksonville, Florida, 32207, United States
Cardiovascular Institute of Northwest Florida
Panama City, Florida, 32405, United States
Heart & Vascular Institute of Florida
Safety Harbor, Florida, 34695-6604, United States
Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
Sarasota, Florida, 34233, United States
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701-1943, United States
Deaconess Specialty Physicians
Evansville, Indiana, 47710, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
Kansas University Medical Center
Kansas City, Kansas, 66160-8500, United States
Saint Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
Norton Heart Specialists
Louisville, Kentucky, 40205-3373, United States
Our Lady of the Lake Office of Research
Baton Rouge, Louisiana, 70808, United States
MedStar Health Research Institute
Baltimore, Maryland, 21237-3958, United States
Tidal Health Peninsula Regional
Salisbury, Maryland, 21804-6938, United States
Associates in Cardiology PA
Silver Spring, Maryland, 20910-1265, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2621, United States
Brigham & Women's Hospital (Boston, MA)
Boston, Massachusetts, 02115-6110, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
UP Health System - Marquette
Marquette, Michigan, 49855-2705, United States
Michigan Heart
Ypsilanti, Michigan, 48197-8633, United States
North Memorial Heart and Vascular Institute
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Missouri Cardiovascular Specialists
Columbia, Missouri, 65201-8023, United States
University Hospital of Missouri
Columbia, Missouri, 65212, United States
Saint Lukes Health System
Kansas City, Missouri, 64111-5934, United States
Washington University
St Louis, Missouri, 63110-1010, United States
Nebraska Medicine
Omaha, Nebraska, 68105, United States
Monmouth Cardiology Associates
Ocean City, New Jersey, 07712-4762, United States
Presbyterian Heart Group
Albuquerque, New Mexico, 87106-4921, United States
South Shore University Hospital
Bay Shore, New York, 11706, United States
Huntington Hospital
Huntington, New York, 11743, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Northern Westchester Hospital
Mount Kisco, New York, 10549, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10021, United States
New York-Presbyterian Hospital/Columbia University Medical Center
New York, New York, 10032, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Hudson Valley Heart Center
Poughkeepsie, New York, 12601-3923, United States
Staten Island University Hospital
Staten Island, New York, 10305-3436, United States
Duke University Medical Center (DUMC)
Durham, North Carolina, 27705, United States
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610, United States
Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
Akron, Ohio, 44304-1473, United States
The Christ Hospital Health Network
Cincinnati, Ohio, 45219, United States
University of Cincinnati
Cincinnati, Ohio, 45267-0542, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015-1155, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
UPMC Heart and Vascular Institute at UPMC Hamot
Erie, Pennsylvania, 16507-1579, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
Saint Thomas Research Institute
Nashville, Tennessee, 37205-2018, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8802, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705-1852, United States
Heart Center of North Texas
Fort Worth, Texas, 761014, United States
Consultants in Cardiology
Fort Worth, Texas, 76104-2821, United States
EP Heart
The Woodlands, Texas, 77384, United States
Kootenai Heart Clinics Northwest
Spokane, Washington, 99204-2352, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215, United States
Clinique Rhône Durance
Avignon, 84082, France
Centre Hospitalier de la Côte Basque
Bayonne, 64109, France
CHRU Brest - Hôpital de la Cavale Blanche
Brest, 29609, France
Générale de Santé - Hôpital Privé Saint Martin
Caen, 14000, France
CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol
Caen, 14033, France
CHU de Clermont Ferrand
Clermont-Ferrand, 63003, France
CHU de Dijon - Hospital Le Bocage
Dijon, 21079, France
CHRU La Rochelle
La Rochelle, 17019, France
Hopital prive Clairval - Ramsay Sante
Marseille, 13009, France
Nouvelles Cliniques Nantaises
Nantes, France
Centre hospitalier de la région d'Annecy
Pringy, 74374, France
Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord
Saint-Priest-en-Jarez, 42270, France
Capio - Clinique du Tonkin
Villeurbanne, 69100, France
Hygeia Hospital
Athens, 15123, Greece
Athens Medical Center
Marousi, 15125, Greece
Policlinico Sant' Orsola - Malpighi
Bologna, 40138, Italy
Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
Castrovillari, 87012, Italy
Ospedale "Vito Fazzi" Lecce
Lecce, 73100, Italy
Azienda Ospedaliera Ospedale Niguarda Ca Granda
Milan, 20162, Italy
Presidio Ospedaliero Centrale - SS. Annunziata
Taranto, 74024, Italy
Azienda ospedaleria Santa Maria della Misericordia di Udine
Udine, Italy
Hospital da Senhora da Oliveira - Guimarães
Guimarães, 4835-044, Portugal
Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
Lisbon, 1649-035, Portugal
Centro Hospitalar Universitário de São João
Porto, 4200-319, Portugal
Hospital Distrital de Santarém
Santarém, 2000-177, Portugal
Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)
Bratislava, Slovakia
Hospital Universitario da Coruna
A Coruña, 15006, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
Hospital Universitario Clínico San Cecilio
Granada, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Complejo Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010, Spain
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, 15706, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47006, Spain
Hôpitaux Universitaires de Genève
Geneva, 1205, Switzerland
Cardiopark Zurich
Zurich, 8027, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2019
First Posted
July 18, 2019
Study Start
August 21, 2017
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
February 4, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share