Personalized Therapy Study - Attain Stability Quad Post-Approval Study

Heart Failure Clinical Trial

— ASQ  

Official title:

Personalized Therapy Study - Attain Stability Quad Post-Approval Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04024943
• Other study ID #: Attain Stability Quad PAS
• Status: Active, not recruiting
• Start date: August 21, 2017
• Est. completion date: April 2027

Study information

• Verified date: December 2023
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1008
• Est. completion date: April 2027
• Est. primary completion date: January 2027
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Clinique Rhône Durance	Avignon
France	Centre Hospitalier de la Côte Basque	Bayonne
France	CHRU Brest - Hôpital de la Cavale Blanche	Brest
France	CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol	Caen
France	Générale de Santé - Hôpital Privé Saint Martin	Caen
France	CHU de Clermont Ferrand	Clermont-Ferrand
France	CHU de Dijon - Hospital Le Bocage	Dijon
France	CHRU La Rochelle	La Rochelle
France	Hopital prive Clairval - Ramsay Sante	Marseille
France	Nouvelles Cliniques Nantaises	Nantes
France	Centre hospitalier de la région d'Annecy	Pringy
France	Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord	Saint Priest en Jarez
France	Capio - Clinique du Tonkin	Villeurbanne
Greece	Hygeia Hospital	Athens
Greece	Athens Medical Center	Maroúsi
Italy	Policlinico Sant' Orsola - Malpighi	Bologna
Italy	Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"	Castrovillari
Italy	Ospedale "Vito Fazzi" Lecce	Lecce
Italy	Azienda Ospedaliera Ospedale Niguarda Ca Granda	Milano
Italy	Presidio Ospedaliero Centrale - SS. Annunziata	Taranto
Italy	Azienda ospedaleria Santa Maria della Misericordia di Udine	Udine
Portugal	Hospital da Senhora da Oliveira - Guimarães	Guimarães
Portugal	Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE	Lisboa
Portugal	Centro Hospitalar Universitário de São João	Porto
Portugal	Hospital Distrital de Santarém	Santarém
Slovakia	Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)	Bratislava
Spain	Hospital Universitario da Coruna	Coruña
Spain	Hospital Universitario Clínico San Cecilio	Granada
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Complejo Universitario de Salamanca	Salamanca
Spain	Complejo Hospitalario Universitario de Santiago de Compostela	Santiago De Compostela
Spain	Hospital Universitario Nuestra Señora de Candelaria	Tenerife
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Switzerland	Hôpitaux Universitaires de Genève	Geneva
Switzerland	Cardiopark Zurich	Zürich
United Kingdom	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 States	Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists	Akron	Ohio
United States	Phoebe Putney Memorial Hospital	Albany	Georgia
United States	Presbyterian Heart Group	Albuquerque	New Mexico
United States	Alaska Heart	Anchorage	Alaska
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	MedStar Health Research Institute	Baltimore	Maryland
United States	Our Lady of the Lake Office of Research	Baton Rouge	Louisiana
United States	South Shore University Hospital	Bay Shore	New York
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania
United States	Brigham & Women's Hospital (Boston, MA)	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Southwest EP	Chandler	Arizona
United States	Chula Vista Cardiac Center	Chula Vista	California
United States	The Christ Hospital Health Network	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Colorado Springs Cardiology	Colorado Springs	Colorado
United States	Missouri Cardiovascular Specialists	Columbia	Missouri
United States	University Hospital of Missouri	Columbia	Missouri
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Denver Heart	Denver	Colorado
United States	Duke University Medical Center (DUMC)	Durham	North Carolina
United States	Saint Elizabeth Healthcare	Edgewood	Kentucky
United States	UPMC Heart and Vascular Institute at UPMC Hamot	Erie	Pennsylvania
United States	Deaconess Specialty Physicians	Evansville	Indiana
United States	Consultants in Cardiology	Fort Worth	Texas
United States	Heart Center of North Texas	Fort Worth	Texas
United States	Hartford Hospital	Hartford	Connecticut
United States	Heart Rhythm Solutions	Hollywood	Florida
United States	Huntington Hospital	Huntington	New York
United States	Baptist Health	Jacksonville	Florida
United States	Cardiology Associates of Northeast Arkansas	Jonesboro	Arkansas
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Saint Lukes Health System	Kansas City	Missouri
United States	Colorado Heart and Vascular	Lakewood	Colorado
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Saint Vincent Heart Clinic Arkansas	Little Rock	Arkansas
United States	Norton Heart Specialists	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	UP Health System - Marquette	Marquette	Michigan
United States	Aurora Cardiovascular Services	Milwaukee	Wisconsin
United States	Northern Westchester Hospital	Mount Kisco	New York
United States	Saint Thomas Research Institute	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Lenox Hill Hospital	New York	New York
United States	New York-Presbyterian Hospital/Columbia University Medical Center	New York	New York
United States	New York-Presbyterian Hospital/Weill Cornell Medical Center	New York	New York
United States	Monmouth Cardiology Associates	Ocean City	New Jersey
United States	Nebraska Medicine	Omaha	Nebraska
United States	Cardiovascular Institute of Northwest Florida	Panama City	Florida
United States	Hudson Valley Heart Center	Poughkeepsie	New York
United States	WakeMed Health & Hospitals	Raleigh	North Carolina
United States	North Memorial Heart and Vascular Institute	Robbinsdale	Minnesota
United States	Mayo Clinic	Rochester	Minnesota
United States	Heart & Vascular Institute of Florida	Safety Harbor	Florida
United States	Washington University	Saint Louis	Missouri
United States	Tidal Health Peninsula Regional	Salisbury	Maryland
United States	San Diego Arrhythmia Associates	San Diego	California
United States	Heart Rhythm Consultants P.A. (Sarasota Memorial Research)	Sarasota	Florida
United States	Associates in Cardiology PA	Silver Spring	Maryland
United States	Kootenai Heart Clinics Northwest	Spokane	Washington
United States	Staten Island University Hospital	Staten Island	New York
United States	EP Heart	The Woodlands	Texas
United States	COR Healthcare	Torrance	California
United States	Cardiovascular Consultants Medical Group (Van Nuys)	Van Nuys	California
United States	Cardiology Associates Medical Group	Ventura	California
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	Michigan Heart	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  France,  Greece,  Italy,  Portugal,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	5 years
Secondary	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	5 years