Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy

RecruitingOBSERVATIONAL
Enrollment

620

Participants

Timeline

Start Date

January 21, 2020

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2026

Conditions
Heart Failure
Interventions
DEVICE

OPTIMIZER Smart System

"Eligible subjects will receive the OPTIMIZER Smart, which is comprised of three major components:~1. Optimizer Smart or Optimizer Smart Mini~2. Vesta Charger or Guardio Charger~3. Two commercially available intravascular leads"

Trial Locations (93)

10025

RECRUITING

Mount Sinai Morningside, New York

15212

RECRUITING

Allegheny General Hospital, Pittsburgh

15213

RECRUITING

UPMC Heart and Vascular Institute, Pittsburgh

17011

RECRUITING

UPMC Pinnacle Health, Harrisburg

17033

RECRUITING

Penn State Milton S. Hershey Medical Center, Hershey

17602

RECRUITING

Penn Medicine Lancaster General Hospital, Lancaster

18104

RECRUITING

St. Luke's University Health Network, Allentown

19010

RECRUITING

Bryn Mawr Hospital, Bryn Mawr

19067

RECRUITING

Cardiology Consultants of Philadelphia, Philadelphia

RECRUITING

Cardiovascular Consultants of Philadelphia, Yardley

19104

COMPLETED

Hospital of the University of Pennsylvania, Philadelphia

RECRUITING

Penn Presybyterian Medical Center, Philadelphia

19140

RECRUITING

Temple University Hospital, Philadelphia

19141

RECRUITING

Einstein Medical Center, Philadelphia

19611

RECRUITING

Reading Hospital, Reading

20010

NOT_YET_RECRUITING

MedStar Washington Hospital Center, Washington D.C.

23114

RECRUITING

Bon Secours St. Mary's Hospital, Midlothian

23225

RECRUITING

HCA Chippenham Hospital, Richmond

23249

RECRUITING

Richmond VA Medical Center, Richmond

24501

RECRUITING

Centra Health- Lynchburg General Hospital, Lynchburg

25304

COMPLETED

CAMC Clinical Trials Center, Charleston

25701

RECRUITING

Marshall Cardiology, Huntington

27607

RECRUITING

NC Heart and Vascular Research, Raleigh

28204

RECRUITING

Atrium Health, Charlotte

28801

RECRUITING

Mission Health, Asheville

30165

RECRUITING

Redmond Regional Medical Center, Rome

30309

COMPLETED

Piedmont Heart, Atlanta

32216

RECRUITING

Florida Memorial Hospital, Jacksonville

32792

ACTIVE_NOT_RECRUITING

Florida Cardiology, Orlando

33324

RECRUITING

Florida Heart Rhythm Specialist, Plantation

33328

ACTIVE_NOT_RECRUITING

Heart Rhythm Solutions, Davie

38374

RECRUITING

Ascension Providence Park Hospital, Novi

40503

RECRUITING

Baptist Lexington, Lexington

40536

RECRUITING

University of Kentucky - Gill Heart & Vascular Institute Clinical Research, Lexington

43210

RECRUITING

The Ohio State University, Columbus

43213

COMPLETED

Mount Carmel Research institute, Columbus

43606

ACTIVE_NOT_RECRUITING

ProMedica Health Systems, Toledo

43608

RECRUITING

Mercy Health - St. Vincent Medical Center, Toledo

43952

RECRUITING

Regional Cardiac Arrythmia Inc., Steubenville

44106

RECRUITING

University Hospitals of Cleveland Medical Center, Cleveland

45242

RECRUITING

TriHealth Hatton, Cincinnati

46237

RECRUITING

Franciscan Physician Network, Indianapolis

46260

RECRUITING

Ascension St. Vincent, Indianapolis

46321

ACTIVE_NOT_RECRUITING

Community Healthcare System, Munster

48195

RECRUITING

Downriver Heart and Vascular, Southgate

48197

RECRUITING

Trinity Health Michigan Heart, Ypsilanti

48307

WITHDRAWN

Ascension Providence Rochester, Rochester

48341

COMPLETED

St. Joseph Mercy Oakland, Pontiac

48912

WITHDRAWN

Sparrow Clinical Research Institute, Lansing

53215

RECRUITING

Aurora Research Institute, Milwaukee

55407

RECRUITING

Minneapolis Heart Institute Foundation - Allina, Minneapolis

59901

RECRUITING

Logan Health, Kalispell

60515

COMPLETED

Advocate Good Samaritan Hospital, Downers Grove

60657

COMPLETED

Advocate Illinois Masonic Medical Center, Chicago

61107

RECRUITING

OSF HealthCare Cardiovascular Institute, Rockford

61614

RECRUITING

OSF Healthcare Cardiovascular Institute, Peoria

61801

RECRUITING

OSF Healthcare Cardiovascular Institute, Urbana

63044

RECRUITING

St. Louis Heart and Vascular, Bridgeton

73120

RECRUITING

Oklahoma Heart Hospital, Oklahoma City

75216

RECRUITING

VA North Texas Medical Center, Dallas

75702

RECRUITING

CHRISTUS Trinity Clinic Research, Tyler

77030

RECRUITING

Baylor College of Medicine, Houston

RECRUITING

UT Health - Memorial Hermann Hospital, Houston

78229

COMPLETED

Heart and Rhythm Institute of South Texas, San Antonio

RECRUITING

UT Health San Antonio, San Antonio

78705

RECRUITING

Texas Cardiac Arrhythmia Research, Austin

79915

RECRUITING

Texan Procedure Center, El Paso

80012

RECRUITING

Aurora Denver Cardiology Associates, Aurora

85006

RECRUITING

Banner University Medical Center, Phoenix

RECRUITING

Cardiovascular Society of Arizona, Phoenix

85016

RECRUITING

Arizona Cardiovascular Research Center, Phoenix

85206

RECRUITING

CardioVascular Associates of Mesa (CVAM), Mesa

RECRUITING

Chan Heart Rhythm Institute (CHRI), Mesa

RECRUITING

Southwest Cardiovascular Associates, Mesa

85258

RECRUITING

Honor Health, Scottsdale

85712

RECRUITING

Pima Heart and Vascular Research Center, Tucson

85724

RECRUITING

University of AZ - Sarver Heart Center, Tucson

90033

RECRUITING

University of Southern California - Keck School of Medicine, Los Angeles

90048

RECRUITING

Cedars-Sinai Medical Center, Los Angeles

90505

RECRUITING

Torrance Memorial Medical Center, Torrance

91105

RECRUITING

Valley Clinical Trials, Pasadena

91325

RECRUITING

Valley Clinical Trials, Northridge

91911

RECRUITING

Cardiovascular Institute of San Diego, Chula Vista

92653

ACTIVE_NOT_RECRUITING

South Orange County Cardiology Group, Laguna Hills

93720

RECRUITING

Mid Valley Cardiology - Fresno, Fresno

94533

RECRUITING

NorthBay Health, Heart and Vascular, Fairfield

02241

RECRUITING

Massachusetts General Hospital, Boston

08035

RECRUITING

Cooper Hospital, Haddon Heights

08053

RECRUITING

Virtua Health - Our Lady of Lourdes, Marlton

07960

RECRUITING

Morristown Medical Center, Morristown

07753

WITHDRAWN

Jersey Shore University Medical Center, Neptune City

07719

RECRUITING

Rutgers Medical School, Newark

07450

RECRUITING

Valley Hospital, Ridgewood

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Impulse Dynamics

INDUSTRY

NCT03970343 - Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy | Biotech Hunter | Biotech Hunter