Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation

CompletedOBSERVATIONAL
Enrollment

415

Participants

Timeline

Start Date

March 4, 2019

Primary Completion Date

May 3, 2024

Study Completion Date

May 3, 2024

Conditions
Paroxysmal Atrial Fibrillation
Interventions
DEVICE

Boston Scientific Open Irrigated Ablation Catheters

The BSC Open-Irrigated catheters are designed to deliver RF energy to catheter tip electrode for cardiac ablation. The BSC OI catheters incorporate an open-irrigated cooling mechanism through a tip that is partitioned into two chambers. The proximal chamber circulates normal saline (0.9 %) within the tip to cool the proximal electrode and mitigate overheating while the distal chamber allows the fluid to flow through six irrigation holes into the patient's vasculature, thereby cooling the tip/tissue interface.

Trial Locations (26)

2841

Korea University Medical Center, Seoul

13347

Juedisches Krankenhaus Berlin, Mitte

14213

Kaleida Health, Buffalo

18103

Lehigh Valley Hospital, Allentown

32803

AdventHealth Orlando, Orlando

33136

Broward General Medical Center, Miami

35294

University of Alabama at Birmingham, Birmingham

42601

Keimyung University Dongsan Medical Center, Daegu

44195

Cleveland Clinic Foundation, Cleveland

45220

Bethesda North Hospital, Cincinnati

52242

University of Iowa Hospitals and Clinics, Iowa City

60637

University of Chicago Hospital, Chicago

62769

St. John's Hospital, Springfield

68526

Nebraska Heart Institute, Lincoln

75701

Christus Trinity Mother Frances Health System, Tyler

76021

HeartPlace Mid-Cities EP, Bedford

76133

Staedtisches Klinikum Karlsruhe, Karlsruhe

77505

Orion Medical, Pasadena

83712

St. Lukes Idaho Cardiology Associates, Boise

90505

Torrance Memorial Medical Center, Torrance

98000

Centre Hospitalier Princesse Grace, Monaco

03756-1000

Dartmouth Hitchcock Medical Center, Lebanon

03102

Catholic Medical Center, Manchester

802-8555

Kokura Memorial Hospital, Fukuoka-ken

238-8558

Yokosuka Kyosai Hospital, Kanagawa Prefecture

CB2 0AY

Papworth Hospital, Cambridge

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY

NCT03729830 - Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation | Biotech Hunter | Biotech Hunter