ASQ: Personalized Therapy Study - Attain Stability Quad Post-Approval Study
Sponsor
Medtronic (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04024943
Collaborator
(none)
1,000
115
115.3
8.7
0.1
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Personalized Therapy Study - Attain Stability Quad Post-Approval Study
Actual Study Start Date
:
Aug 21, 2017
Anticipated Primary Completion Date
:
Jan 1, 2027
Anticipated Study Completion Date
:
Apr 1, 2027
Outcome Measures
Primary Outcome Measures
- Percentage of patients without a lead- related event at 5 years post-implant [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.
Secondary Outcome Measures
- Number of lead-related adverse device effects [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
- Number of explanted leads that have been returned [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
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alaska Heart | Anchorage | Alaska | United States | 99508-4673 |
| 2 | Southwest EP | Chandler | Arizona | United States | 85295-1680 |
| 3 | Cardiology Associates of Northeast Arkansas | Jonesboro | Arkansas | United States | 72410-4163 |
| 4 | Saint Vincent Heart Clinic Arkansas | Little Rock | Arkansas | United States | 72205-6202 |
| 5 | Chula Vista Cardiac Center | Chula Vista | California | United States | 91910 |
| 6 | San Diego Arrhythmia Associated | San Diego | California | United States | 92103 |
| 7 | COR Healthcare | Torrance | California | United States | 90505 |
| 8 | Cardiovascular Consultants Medical Group (Van Nuys) | Van Nuys | California | United States | 91405-3646 |
| 9 | Cardiology Associates Medical Group | Ventura | California | United States | 93003 |
| 10 | Colorado Springs Cardiology | Colorado Springs | Colorado | United States | 80907 |
| 11 | Denver Heart | Denver | Colorado | United States | 80220-3918 |
| 12 | Colorado Heart and Vascular | Lakewood | Colorado | United States | 80228 |
| 13 | Hartford Hospital | Hartford | Connecticut | United States | 06102 |
| 14 | Yale New Haven Health System | New Haven | Connecticut | United States | 06520-8017 |
| 15 | Clearwater Cardiovascular Consultants | Clearwater | Florida | United States | 33756-3356 |
| 16 | Heart Rhythm Solutions | Hollywood | Florida | United States | 33021 |
| 17 | Baptist Health | Jacksonville | Florida | United States | 32207 |
| 18 | Cardiovascular Institute of Northwest Florida | Panama City | Florida | United States | 32405 |
| 19 | Heart & Vascular Institute of Florida | Safety Harbor | Florida | United States | 34695-6604 |
| 20 | Heart Rhythm Consultants P.A. | Sarasota | Florida | United States | 34233 |
| 21 | Phoebe Putney Memorial Hospital | Albany | Georgia | United States | 31701-1943 |
| 22 | Deaconess Specialty Physicians | Evansville | Indiana | United States | 47710 |
| 23 | Iowa Heart Center | West Des Moines | Iowa | United States | 50266 |
| 24 | Kansas University Medical Center | Kansas City | Kansas | United States | 66160-8500 |
| 25 | Saint Elizabeth Healthcare | Edgewood | Kentucky | United States | 41017 |
| 26 | Norton Heart Specialists | Louisville | Kentucky | United States | 40205-3373 |
| 27 | Our Lady of the Lake Office of Research | Baton Rouge | Louisiana | United States | 70808 |
| 28 | MedStar Health Research Institute | Baltimore | Maryland | United States | 21237-3958 |
| 29 | TidalHealth Peninsula Regional, Inc. | Salisbury | Maryland | United States | 21804-6938 |
| 30 | Associates in Cardiology PA | Silver Spring | Maryland | United States | 20910-1265 |
| 31 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114-2621 |
| 32 | Brigham & Women's Hospital (Boston, MA) | Boston | Massachusetts | United States | 02115-6110 |
| 33 | Sparrow Clinical Research Institute | Lansing | Michigan | United States | 48912 |
| 34 | UP Health System - Marquette | Marquette | Michigan | United States | 49855-2705 |
| 35 | Michigan Heart | Ypsilanti | Michigan | United States | 48197-8633 |
| 36 | North Memorial Heart and Vascular Institute | Robbinsdale | Minnesota | United States | 55422 |
| 37 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 38 | Missouri Cardiovascular Specialists | Columbia | Missouri | United States | 65201-8023 |
| 39 | University Hospital of Missouri | Columbia | Missouri | United States | 65212 |
| 40 | Saint Lukes Health System | Kansas City | Missouri | United States | 64111-5934 |
| 41 | Washington University | Saint Louis | Missouri | United States | 63110-1010 |
| 42 | Nebraska Medicine | Omaha | Nebraska | United States | 68105 |
| 43 | Monmouth Cardiology Associates | Ocean City | New Jersey | United States | 07712-4762 |
| 44 | Presbyterian Heart Group | Albuquerque | New Mexico | United States | 87106-4921 |
| 45 | South Shore University Hospital | Bay Shore | New York | United States | 11706 |
| 46 | Huntington Hospital | Huntington | New York | United States | 11743 |
| 47 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 48 | Northern Westchester Hospital | Mount Kisco | New York | United States | 10549 |
| 49 | Long Island Jewish Medical Center | New Hyde Park | New York | United States | 11040 |
| 50 | New York-Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | United States | 10021 |
| 51 | New York-Presbyterian Hospital/Columbia University Medical Center | New York | New York | United States | 10032 |
| 52 | Lenox Hill Hospital | New York | New York | United States | 10075 |
| 53 | Hudson Valley Heart | Poughkeepsie | New York | United States | 12601-3923 |
| 54 | Staten Island University Hospital | Staten Island | New York | United States | 10305-3436 |
| 55 | Duke University Medical Center (DUMC) | Durham | North Carolina | United States | 27705 |
| 56 | WakeMed | Raleigh | North Carolina | United States | 27610 |
| 57 | Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists | Akron | Ohio | United States | 44304-1473 |
| 58 | The Christ Hospital Health Network | Cincinnati | Ohio | United States | 45219 |
| 59 | University of Cincinnati | Cincinnati | Ohio | United States | 45267-0542 |
| 60 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 61 | St. Lukes University Health Network | Bethlehem | Pennsylvania | United States | 18015-1155 |
| 62 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
| 63 | UPMC Heart and Vascular Institute at UPMC Hamot | Erie | Pennsylvania | United States | 16507-1579 |
| 64 | Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
| 65 | Saint Thomas Research Institute | Nashville | Tennessee | United States | 37205-2018 |
| 66 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232-8802 |
| 67 | Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | United States | 78705-1852 |
| 68 | Heart Center of North Texas | Fort Worth | Texas | United States | 761014 |
| 69 | Consultants in Cardiology | Fort Worth | Texas | United States | 76104-2821 |
| 70 | Heart Center of North Texas | Fort Worth | Texas | United States | 76104 |
| 71 | EP Heart | The Woodlands | Texas | United States | 77384 |
| 72 | Kootenai Heart Clinics Northwest | Spokane | Washington | United States | 99204-2352 |
| 73 | Aurora Cardiovascular Services | Milwaukee | Wisconsin | United States | 53215 |
| 74 | Clinique Rhône Durance | Avignon | France | 17019 | |
| 75 | Centre Hospitalier de la Côte Basque | Bayonne | France | 64109 | |
| 76 | CHRU Brest - Hôpital de la Cavale Blanche | Brest | France | 29609 | |
| 77 | Générale de Santé - Hôpital Privé Saint Martin | Caen | France | 14000 | |
| 78 | CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol | Caen | France | 14033 | |
| 79 | CHU de Clermont Ferrand | Clermont-Ferrand | France | ||
| 80 | CHU de Dijon - Hospital Le Bocage | Dijon | France | ||
| 81 | CHRU La Rochelle | La Rochelle | France | 17019 | |
| 82 | Hopital prive Clairval - Ramsay Sante | Marseille | France | 13009 | |
| 83 | Ch de La Region D'Annecy | Metz-Tessy | France | ||
| 84 | Nouvelles Cliniques Nantaises | Nantes | France | ||
| 85 | Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord | Saint Priest en Jarez | France | 42270 | |
| 86 | Capio - Clinique du Tonkin | Villeurbanne | France | ||
| 87 | Hygeia Hospital | Athens | Greece | ||
| 88 | Athens Medical Center | Maroúsi | Greece | ||
| 89 | Policlinico Sant' Orsola - Malpighi | Bologna | Italy | ||
| 90 | Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari" | Cosenza | Italy | ||
| 91 | Ospedale "Vito Fazzi" Lecce | Lecce | Italy | ||
| 92 | Azienda Ospedaliera Ospedale Niguarda Ca Granda | Milano | Italy | 20162 | |
| 93 | Presidio Ospedaliero Centrale - SS. Annunziata | Taranto | Italy | ||
| 94 | Azienda ospedaleria Santa Maria della Misericordia di Udine | Udine | Italy | ||
| 95 | Hospital da Senhora da Oliveira - Guimarães | Guimarães | Portugal | ||
| 96 | Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE | Lisboa | Portugal | ||
| 97 | Centro Hospitalar Universitário de São João | Porto | Portugal | ||
| 98 | Hospital Distrital de Santarém | Santarém | Portugal | ||
| 99 | Hospital Universitario da Coruna | Coruña | Spain | 15006 | |
| 100 | Hospital Universitario Clínico San Cecilio | Granada | Spain | ||
| 101 | Hospital Universitario Virgen de las Nieves | Granada | Spain | ||
| 102 | Complejo Universitario de Salamanca | Salamanca | Spain | ||
| 103 | Complejo Hospitalario Universitario de Santiago de Compostela | Santiago De Compostela | Spain | 15706 | |
| 104 | Hospital Universitario Nuestra Señora de Candelaria | Tenerife | Spain | ||
| 105 | Hospital Clínico Universitario de Valladolid | Valladolid | Spain | ||
| 106 | Kantonsspital Aarau | Aarau | Switzerland | 5001 | |
| 107 | Hôpitaux Universitaires de Genève | Geneva | Switzerland | 1205 | |
| 108 | Cardiopark Zurich | Zürich | Switzerland | 8027 | |
| 109 | University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital | Birmingham | United Kingdom | ||
| 110 | Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital | Blackpool | United Kingdom | ||
| 111 | Liverpool Heart and Chest Hospital NHS Foundation Trust | Liverpool | United Kingdom | ||
| 112 | Imperial College Healthcare NHS Trust - Hammersmith Hospital | London | United Kingdom | ||
| 113 | Central Manchester University Hospitals NHS - Manchester Royal Infirmary | Manchester | United Kingdom | ||
| 114 | The James Cook University Hospital - South Tees Hospitals NHS | Middlesbrough | United Kingdom | ||
| 115 | Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General | Sheffield | United Kingdom |
Sponsors and Collaborators
- Medtronic
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Medtronic
ClinicalTrials.gov Identifier:
NCT04024943
Other Study ID Numbers:
- Attain Stability Quad PAS
First Posted:
Jul 18, 2019
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms: