Personalized Therapy Study - Attain Stability Quad Post-Approval Study

Active, not recruitingOBSERVATIONAL
Enrollment

1,092

Participants

Timeline

Start Date

August 21, 2017

Primary Completion Date

July 31, 2027

Study Completion Date

January 31, 2028

Conditions
Heart Failure
Interventions
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.

Trial Locations (115)

1205

Hôpitaux Universitaires de Genève, Geneva

8027

Cardiopark Zurich, Zurich

10021

New York-Presbyterian Hospital/Weill Cornell Medical Center, New York

10032

New York-Presbyterian Hospital/Columbia University Medical Center, New York

10075

Lenox Hill Hospital, New York

10549

Northern Westchester Hospital, Mount Kisco

11030

North Shore University Hospital, Manhasset

11040

Long Island Jewish Medical Center, New Hyde Park

11706

South Shore University Hospital, Bay Shore

11743

Huntington Hospital, Huntington

13009

Hopital prive Clairval - Ramsay Sante, Marseille

14000

Générale de Santé - Hôpital Privé Saint Martin, Caen

14033

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

15006

Hospital Universitario da Coruna, A Coruña

15123

Hygeia Hospital, Athens

15125

Athens Medical Center, Marousi

15706

Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela

17019

CHRU La Rochelle, La Rochelle

17822

Geisinger Medical Center, Danville

18014

Hospital Universitario Virgen de las Nieves, Granada

18711

Geisinger Wyoming Valley Medical Center, Wilkes-Barre

20162

Azienda Ospedaliera Ospedale Niguarda Ca Granda, Milan

21079

CHU de Dijon - Hospital Le Bocage, Dijon

27610

WakeMed Health & Hospitals, Raleigh

27705

Duke University Medical Center (DUMC), Durham

28041

Hospital Universitario 12 de Octubre, Madrid

29609

CHRU Brest - Hôpital de la Cavale Blanche, Brest

32207

Baptist Health, Jacksonville

32405

Cardiovascular Institute of Northwest Florida, Panama City

33021

Heart Rhythm Solutions, Hollywood

34233

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

37007

Complejo Universitario de Salamanca, Salamanca

38010

Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife

40138

Policlinico Sant' Orsola - Malpighi, Bologna

41017

Saint Elizabeth Healthcare, Edgewood

42270

Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord, Saint-Priest-en-Jarez

44195

Cleveland Clinic, Cleveland

45219

The Christ Hospital Health Network, Cincinnati

47006

Hospital Clínico Universitario de Valladolid, Valladolid

47710

Deaconess Specialty Physicians, Evansville

48912

Sparrow Clinical Research Institute, Lansing

50266

Iowa Heart Center, West Des Moines

53215

Aurora Cardiovascular Services, Milwaukee

55422

North Memorial Heart and Vascular Institute, Robbinsdale

55905

Mayo Clinic, Rochester

63003

CHU de Clermont Ferrand, Clermont-Ferrand

64109

Centre Hospitalier de la Côte Basque, Bayonne

65212

University Hospital of Missouri, Columbia

68105

Nebraska Medicine, Omaha

69100

Capio - Clinique du Tonkin, Villeurbanne

70808

Our Lady of the Lake Office of Research, Baton Rouge

73100

"Ospedale Vito Fazzi Lecce", Lecce

74024

Presidio Ospedaliero Centrale - SS. Annunziata, Taranto

74374

Centre hospitalier de la région d'Annecy, Pringy

77384

EP Heart, The Woodlands

80228

Colorado Heart and Vascular, Lakewood

80907

Colorado Springs Cardiology, Colorado Springs

84082

Clinique Rhône Durance, Avignon

87012

"Azienda Sanitaria Provinciale di Cosenza Ospedale di Castrovillari", Castrovillari

90505

COR Healthcare, Torrance

91910

Chula Vista Cardiac Center, Chula Vista

92103

San Diego Arrhythmia Associates, San Diego

93003

Cardiology Associates Medical Group, Ventura

761014

Heart Center of North Texas, Fort Worth

99508-4673

Alaska Heart, Anchorage

85295-1680

Southwest EP, Chandler

72410-4163

Cardiology Associates of Northeast Arkansas, Jonesboro

72205-6202

Saint Vincent Heart Clinic Arkansas, Little Rock

91405-3646

Cardiovascular Consultants Medical Group (Van Nuys), Van Nuys

80220-3918

Denver Heart, Denver

06102

Hartford Hospital, Hartford

06520-8017

Yale New Haven Hospital, New Haven

33756-3356

Clearwater Cardiovascular Consultants, Clearwater

34695-6604

Heart & Vascular Institute of Florida, Safety Harbor

31701-1943

Phoebe Putney Memorial Hospital, Albany

66160-8500

Kansas University Medical Center, Kansas City

40205-3373

Norton Heart Specialists, Louisville

21237-3958

MedStar Health Research Institute, Baltimore

21804-6938

Tidal Health Peninsula Regional, Salisbury

20910-1265

Associates in Cardiology PA, Silver Spring

02114-2621

Massachusetts General Hospital, Boston

02115-6110

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

49855-2705

UP Health System - Marquette, Marquette

48197-8633

Michigan Heart, Ypsilanti

65201-8023

Missouri Cardiovascular Specialists, Columbia

64111-5934

Saint Lukes Health System, Kansas City

63110-1010

Washington University, St Louis

07712-4762

Monmouth Cardiology Associates, Ocean City

87106-4921

Presbyterian Heart Group, Albuquerque

12601-3923

Hudson Valley Heart Center, Poughkeepsie

10305-3436

Staten Island University Hospital, Staten Island

44304-1473

Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists, Akron

45267-0542

University of Cincinnati, Cincinnati

18015-1155

St. Luke's University Health Network, Bethlehem

16507-1579

UPMC Heart and Vascular Institute at UPMC Hamot, Erie

37205-2018

Saint Thomas Research Institute, Nashville

37232-8802

Vanderbilt University Medical Center, Nashville

78705-1852

Texas Cardiac Arrhythmia Research Foundation, Austin

76104-2821

Consultants in Cardiology, Fort Worth

99204-2352

Kootenai Heart Clinics Northwest, Spokane

Unknown

Nouvelles Cliniques Nantaises, Nantes

Azienda ospedaleria Santa Maria della Misericordia di Udine, Udine

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

Hospital Universitario Clínico San Cecilio, Granada

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

4835-044

Hospital da Senhora da Oliveira - Guimarães, Guimarães

1649-035

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

4200-319

Centro Hospitalar Universitário de São João, Porto

2000-177

Hospital Distrital de Santarém, Santarém

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medtronic

INDUSTRY