Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD

NAActive, not recruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

March 12, 2021

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2032

Conditions
Heart Septal DefectHeart Septal Defects, AtrialHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital Abnormalities
Interventions
DEVICE

reSept ASD Occluder

Transcatheter closure of secundum ASD using a permanent implant

Trial Locations (32)

1011

Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne

8032

University Children's Hospital Zurich, Zurich

10029

Mount Sinai Medical Center, New York

15224

UPMC Children's Hospital of Pittsburgh, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

22908

University of Virginia, Charlottesville

29425

Medical University of South Carolina, Charleston

30322

Children's Healthcare of Atlanta, Atlanta

31059

Hôpital des Enfants (CHU Toulouse), Toulouse

33021

Joe DiMaggio Children's Hospital/Memorial Healthcare System, Hollywood

33604

Hôpital cardiologique Haut-Leveque (CHU Bordeaux), Bordeaux

35233

University of Alabama at Birmingham, Birmingham

43215

Nationwide Children's Hospital, Columbus

44093

Hôpital Mere Enfants (CHU Nantes), Nantes

45229

Cincinnati Children's Hospital, Cincinnati

46202

Riley Hospital for Children, Indianapolis

48109

University of Michigan, Ann Arbor

48202

Children's Hospital of Michigan, Detroit

59000

Service de Cardiologie Pédiatrique et Congénitale, Lille

60453

Advocate Children's Hospital, Oak Lawn

63110

Washington University School of Medicine, St Louis

75015

Hôpital Necker Enfants Malades, Paris

75230

Medical City Dallas Hospital, Dallas

77030

Texas Children's Hospital, Houston

80045

Children's Hospital Colorado, Aurora

84113

Primary Children's Hospital, Salt Lake City

90027

Children's Hospital of Los Angeles, Los Angeles

91360

Los Robles Regional Medical Center, Thousand Oaks

98105

Seattle Children's Hospital, Seattle

06510

Yale University, New Haven

02115

Boston Children's Hospital, Boston

6EN-249

Toronto General Hospital, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

atHeart Medical

INDUSTRY