Assessment of CCM in HF With Higher Ejection Fraction

NARecruitingINTERVENTIONAL
Enrollment

1,500

Participants

Timeline

Start Date

February 3, 2022

Primary Completion Date

February 1, 2029

Study Completion Date

February 1, 2029

Conditions
Heart FailureHeart Failure With Preserved Ejection FractionHeart Failure With Mid Range Ejection FractionHeart Failure With Moderately Reduced Ejection FractionDiastolic Heart Failure
Interventions
DEVICE

Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System

The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed ON for the first 18 months (blinded phase). CCM therapy will be programmed to deliver 7 one-hour phases of CCM therapy that are distributed equally over every 24-hour period. CCM will remain on following completion of the 18-month visit.

DEVICE

OPTIMIZER™ Smart Mini System

The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed OFF for the first 18 months (blinded phase). CCM will be turned on following completion of the 18-month visit.

Trial Locations (105)

10021

WITHDRAWN

Weill Cornell Medicine, New York

15212

RECRUITING

Allegheny General Hospital, Pittsburgh

15213

RECRUITING

University of Pittsburgh Medical Center, Pittsburgh

17033

RECRUITING

Penn State Hershey Medical City, Hershey

17110

WITHDRAWN

UPMC Pinnacle Harrisburg, Harrisburg

17403

WITHDRAWN

WellSpan Health, York

17602

WITHDRAWN

Lancaster General Hospital, Lancaster

19010

RECRUITING

Bryn Mawr Medical Specialists Association, Bryn Mawr

19104

RECRUITING

Hospital of the University of Pennsylvania, Philadelphia

19107

RECRUITING

Thomas Jefferson University Hospital, Philadelphia

19140

RECRUITING

Temple University Hospital, Philadelphia

19611

WITHDRAWN

Tower Health Reading Hospital, Reading

23226

RECRUITING

Bon Secours St. Mary's, Richmond

28203

WITHDRAWN

Sanger Heart and Vascular, Charlotte

29601

RECRUITING

Prisma Health Upstate, Greenville

29607

RECRUITING

Bon Secours Upstate Cardiology, Greenville

30062

RECRUITING

WellStar Health System, Inc, Marietta

30309

WITHDRAWN

Piedmont Healthcare, Atlanta

32308

RECRUITING

Tallahassee Research Institute, Tallahassee

32803

RECRUITING

AdventHealth Orlando, Orlando

32807

RECRUITING

Revival Clinical Research, Orlando

33021

WITHDRAWN

Memorial Healthcare System, Hollywood

33176

RECRUITING

Baptist Health South Florida, Miami

33189

RECRUITING

Nouvelle Clinical Research LLC, Cutler Bay

33308

WITHDRAWN

Holy Cross Hospital, Fort Lauderdale

33316

RECRUITING

Broward Health, Fort Lauderdale

33326

RECRUITING

Cleveland Clinic Foundation - Florida Weston Hospital, Weston

33462

RECRUITING

HCA Florida JFK Hospital, Atlantis

34102

WITHDRAWN

NCA Research Institute - Florida, Naples

35243

RECRUITING

Grandview Medical Group Research, LLC, Birmingham

35294

WITHDRAWN

The University of Alabama at Birmingham, Birmingham

38138

RECRUITING

The Stern Cardiovascular Foundation, Germantown

38801

WITHDRAWN

North Mississippi Medical Center, Tupelo

40503

RECRUITING

Baptist Health Lexington, Lexington

40506

RECRUITING

University of Kentucky Research Foundation, Lexington

43210

RECRUITING

Ohio State University Wexner Medical Center, Columbus

43214

RECRUITING

OhioHealth Research Institute, Columbus

43608

WITHDRAWN

Mercy Health- St. Vincent Medical Center LLC, Toledo

44106

WITHDRAWN

University Hospitals Cleveland Medical Center, Cleveland

44195

RECRUITING

Cleveland Clinic Foundation, Cleveland

45202

WITHDRAWN

TriHealth Bethesda, Cincinnati

46237

WITHDRAWN

Franciscan Health Indianapolis, Indianapolis

46260

RECRUITING

Ascension Medical Group St. Vincent, Indianapolis

48075

RECRUITING

Ascension Providence Hospital, Southfield

48197

RECRUITING

Trinity health- Michigan Heart, Ypsilanti

48236

RECRUITING

Ascension St. John, Detroit

50266

RECRUITING

MercyOne Iowa Heart, West Des Moines

52242

RECRUITING

University of Iowa, Iowa City

55407

RECRUITING

Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis

63017

WITHDRAWN

St. Luke's Hospital, Chesterfield

63044

RECRUITING

St. Louis Heart and Vascular, Bridgeton

64111

RECRUITING

St. Lukes Hospital Kansas City (Mid America Heart Institute), Kansas City

66160

RECRUITING

University of Kansas Medical Center, Kansas City

66211

RECRUITING

Kansas City Cardiac Arrhythmia Research LLC, Overland Park

68506

RECRUITING

Bryan Heart, Lincoln

70121

WITHDRAWN

Ochsner Clinic Foundation, New Orleans

74104

RECRUITING

Oklahoma Heart Institute, Tulsa

74136

RECRUITING

St. Francis Hospital - Tulsa, Tulsa

75070

RECRUITING

Heart Rhythm Specialists, McKinney

75093

WITHDRAWN

Baylor Scott and White- The Heart Hospital- Plano, Plano

75204

RECRUITING

Baylor Scott and White Research Institute, Dallas

75230

WITHDRAWN

HCA Medical City Dallas, Dallas

76104

RECRUITING

Baylor Scott White- All Saints- Fort Worth, Fort Worth

RECRUITING

Medical City Fort Worth Hospital, Fort Worth

77030

RECRUITING

Baylor College of Medicine, Houston

RECRUITING

Houston Methodist, Houston

RECRUITING

Memorial Hermann Texas Medical Center, Houston

78229

RECRUITING

Methodist Hospital, San Antonio

78665

RECRUITING

Baylor Scott and White Research Institute - Round Rock, Round Rock

78705

WITHDRAWN

Texas Cardiac Arrhythmia Research Foundation, Austin

78723

RECRUITING

Ascension Seton, Austin

78756

RECRUITING

Austin Heart, Austin

85006

WITHDRAWN

Banner Health- Phoenix, Phoenix

85016

RECRUITING

Arizona Heart Rhythm, Phoenix

85032

RECRUITING

Cardiovascular Consultants, Ltd, Phoenix

85206

RECRUITING

CardioVascular Associates of Mesa, Mesa

RECRUITING

Chan Heart Rhythm Institute, Mesa

85208

RECRUITING

Southwest Cardiovascular Associates, Mesa

85258

RECRUITING

HonorHealth, Scottsdale

85712

RECRUITING

Pima Heart and Vascular, Tuscon

90033

RECRUITING

USC Keck School of Medicine, Los Angeles

90048

RECRUITING

Cedars Sinai Medical Center, Los Angeles

91325

WITHDRAWN

Valley Clinical Trials Pasadena, Northridge

RECRUITING

Valley Clinical Trials- Northridge, Northridge

92093

RECRUITING

University of California San Diego, La Jolla

94062

RECRUITING

Sequoia Hospital, Redwood City

94143

RECRUITING

University of California, San Francisco, San Francisco

94520

RECRUITING

John Muir Health, Concord

94533

WITHDRAWN

Northbay Heart and Vascular, Fairfield

95817

WITHDRAWN

University of California Davis Health, Sacramento

97225

RECRUITING

Providence Heart & Vascular, Portland

98122

RECRUITING

Swedish Medical Center, Seattle

98664

RECRUITING

Peace Health, Vancouver

06103

RECRUITING

Hartford Healthcare, Hartford

06897

RECRUITING

Nuvance Health, Wilton

02114

RECRUITING

Massachusetts General Hospital, Boston

68198-5331

RECRUITING

University of Nebraska Medical Center, Omaha

03102

WITHDRAWN

Catholic Medical Center, Manchester

08103

RECRUITING

Our Lady of Lourdes, Camden

08837

WITHDRAWN

Hackensack University Medical Center, Edison

WITHDRAWN

Jersey Shore University Medical Center, Edison

08035

RECRUITING

Cooper Hospital- Cardiovascular Associates of Delaware Valley, Haddon Heights

07960

RECRUITING

Atlantic Health System- Morristown Medical Center, Morristown

08854

WITHDRAWN

Rutgers New Jersey Medical School, Piscataway

19104-6061

RECRUITING

Penn Presbyterian Medical Center, Philadelphia

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Impulse Dynamics

INDUSTRY

NCT05064709 - Assessment of CCM in HF With Higher Ejection Fraction | Biotech Hunter | Biotech Hunter