이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

심부정맥 환자 치료를 위해 상업적으로 승인된 BWI(Biosense Webster) 의료 기기를 사용한 시판 후 관찰 연구 (SECURE)

2026년 11월 2일 업데이트: Biosense Webster, Inc.

심부정맥 환자 치료를 위해 상업적으로 승인된 BWI 의료 기기를 사용한 카테터 매핑 및 절제의 지속적인 안전성 및 유효성 평가를 위한 시판 후 관찰 연구

The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense Webster Inc. (BWI) medical devices. Data generated from the study will be used to confirm safety and performance of BWI medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

관찰

등록 (추정된)

8000

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 네덜란드
      • Maastricht, 네덜란드, 6229 EV
        • 모병
        • Clinical Trial Center Maastricht
      • Rotterdam, 네덜란드, 3015 GD
        • 모병
        • Erasmus University Medical Center
  • 노르웨이
      • Bergen, 노르웨이, 5021
        • 모병
        • Haukeland University Hospital
  • 덴마크
      • Aarhus, 덴마크, 8200
        • 모병
        • Aarhus University Hospital
      • Copenhagen, 덴마크, 2100
        • 모병
        • Rigshospitalet
  • 독일
      • Bad Neustadt an der Saale, 독일, 97616
        • 모병
        • Rhön-Klinikum Campus Bad Neustadt
      • Bad Oeynhausen, 독일, 3245
        • 모병
        • Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum
      • Bad Segeberg, 독일, 23795
        • 모병
        • Segeberger Kliniken
      • Bautzen, 독일, 02625
        • 모병
        • Oberlausitz-Kliniken
      • Essen, 독일, 45131
        • 모병
        • Alfried Krupp Hospital
      • Frankfurt, 독일, 60431
        • 완전한
        • Cardioangiologisches Centrum Bethanien (CCB)
      • Giessen, 독일, 35390
        • 모병
        • Justus-Liebig-University Giessen
      • Hamburg, 독일, 22763
        • 모병
        • Asklepios Klinik Altona
      • Munich, 독일, 80636
        • 모병
        • German Heart Centre Munich
  • 벨기에
      • Aalst, 벨기에, 9300
        • 모병
        • OLV Aalst
      • Bruges, 벨기에, 8000
        • 모병
        • AZ Sint-Jan Brugge
      • Brussels, 벨기에, 1000
        • 모병
        • CHU Saint-Pierre
      • Edegem, 벨기에, 2650
        • 모병
        • UZ Antwerp
      • Ghent, 벨기에, 9000
        • 모병
        • Maria Middelares
      • Hasselt, 벨기에, 3500
        • 모병
        • Jessa Hospital
      • Jette, 벨기에, 1090
        • 모병
        • UZ Brussels
      • La Louvière, 벨기에, 7100
        • 모병
        • ASBL CHU HELORA Hôpital de La Louvière site Jolimont
  • 스웨덴
      • Gothenburg, 스웨덴, 413 45
        • 모병
        • Sahlgrenska University Hospital
  • 스위스
      • Bern, 스위스, 03010
        • 모병
        • INSELSPITAL Universitätsspital Bern
  • 아일랜드
      • Dublin, 아일랜드, D07 WKW8
        • 모병
        • Mater Private Heart and Vascular Centre
  • 영국
      • Leicester, 영국, LE3 9QP
        • 모병
        • Glenfield Hospital
      • London, 영국, SW3 6NP
        • 모병
        • Royal Brompton Hospital
      • London, 영국, SW17 0QT
        • 모병
        • St George's Hospital
      • London, 영국, EC1A 7BE
        • 완전한
        • St. Bartholomew's Hospital
  • 오스트리아
      • Graz, 오스트리아, 8010
        • 모병
        • Medical University of Graz
      • Linz, 오스트리아, 4020
        • 모병
        • Ordensklinikum Linz GMBH
      • Wiener Neustadt, 오스트리아, 2700
        • 모병
        • Universitätsklinikum Wiener Neustadt
  • 이스라엘
      • Jerusalem, 이스라엘, 9103102
        • 모병
        • Shaare Zedek Medical Center
      • Tel Aviv, 이스라엘, 6423906
        • 완전한
        • Tel Aviv Sourasky Medical Center
  • 이탈리아
      • Acquaviva delle Fonti, 이탈리아, 70021
        • 모병
        • Ospedale Generale Regionale "F. Miulli"
      • Ancona, 이탈리아, 60126
        • 모병
        • A.O. Universitaria Delle Marche
      • Milan, 이탈리아, 20097
        • 모병
        • IRCCS Policlinico San Donato
      • Naples, 이탈리아, 80122
        • 모병
        • Clinica Mediterranea
  • 포르투갈
      • Carnaxide, 포르투갈, 2790-134
        • 모병
        • Hospital de Santa Cruz
  • 프랑스
      • Clermont-Ferrand, 프랑스, 63000
        • 모병
        • CHU de Clermont-Ferrand
      • Lyon, 프랑스, 69002
        • 모병
        • Les Hospices Civils de Lyon
      • Marseille, 프랑스, 13285
        • 모병
        • Hôpital Saint Joseph de Marseille
      • Paris, 프랑스, 75674
        • 모병
        • Institut Mutualiste Montsouris
      • Rennes, 프랑스, 35033
        • 모병
        • CHU de Rennes
      • Strasbourg, 프랑스, 67000
        • 모병
        • Les Hôpitaux Universitaires de Strasbourg
      • Talence, 프랑스, 33404
        • 모병
        • Centre Hospitalier Universitaire de Bordeaux
  • 헝가리
      • Budapest, 헝가리, H-1085
        • 모병
        • Semmelweis University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

Study population consists of participants diagnosed with cardiac arrhythmias who are scheduled to undergo an ablation procedure for management of their arrhythmia with a per-protocol defined Biosense Webster Inc (BWI) therapeutic catheter.

설명

Inclusion criteria

  • Diagnosed with paroxysmal or persistent Atrial Fibrillation (AF) or supraventricular tachycardia (SVT) or ventricular tachycardia (VT) and scheduled to undergo an ablation procedure for management of their arrhythmia with a per-protocol defined BW therapeutic catheter
  • Able and willing to comply with all pre, post and follow-up testing and requirements as per hospital standard of care
  • Signed patient informed consent form (ICF) as applicable per local regulation

Exclusion criteria:

  • Currently participating in an interventional (drug, device, biologic) clinical trial
  • Life expectancy of less than 12-months
  • Presenting any contraindication for the use of BWI commercially approved medical devices, as indicated in the respective user manuals

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: COHORT
  • 시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트
개입 / 치료
Participants Diagnosed with Cardiac Arrhythmias

Patients diagnosed with cardiac arrhythmias who are scheduled to undergo an ablation procedure in routine clinical practice for management of their arrhythmia with a BWI therapeutic catheter/Varipulse Catheter/ Dual Energy Thermocool Smarttouch surround flow (SF) catheter will be observed.
장치: BWI Medical Device

Participants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study.

장치: Varipulse Catheter

Participants treated with Varipulse Catheter in the main study will be part of the VARIPURE sub-study. No specific intervention will be observed for this study.

장치: Dual Energy THERMOCOOL SMARTTOUCH SF Catheter

Participants treated with the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter in the main study will be part of the DUACURE sub-study. No specific intervention will be observed for this study.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants with Primary Adverse Events (PAEs) Related to Device in Scope and/or Study Procedure Within 7 Days of the Initial Study Procedure
기간: Up to 7 Days

PAEs in participants with Atrial Fibrillation (AF) and for SupraVentricular Tachycardia (SVT) includes device or procedure related death, atrio-esophageal fistula/ esophageal perforation , severe pulmonary vein stenosis, cardiac tamponade/perforation, thromboembolism, pericarditis, stroke/cerebrovascular accident, transient ischemic attack, phrenic nerve paralysis (permanent), myocardial infarction, major vascular access complication/bleeding, heart block; PAEs in participants with Ventricular Tachycardia (VT) includes device or procedure related death, cardiac tamponade/perforation, thromboembolism, pericarditis, stroke/cerebrovascular accident, transient ischemic attack, phrenic nerve paralysis (permanent), myocardial infarction, major vascular access complication/bleeding, heart block, aggravation or new onset heart failure, coronary artery injury, aortic dissection and valve injury.
Up to 7 Days
AF: Number of Participants with Isolation of all Targeted Pulmonary Veins
기간: Up to 7 Days

Number of Participants with isolation (entrance block confirmation) of all targeted pulmonary veins will be reported.
Up to 7 Days
SVT (Sinus Nodal Re-entrant Tachycardia, Focal AT, Multifocal AT, AVNRT, Non Re-entrant Junctional Tachycardias): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure
기간: Up to 7 Days

Number of participants with sinus nodal re-entrant tachycardia, focal atrial tachycardia (AT) multifocal AT, atrioventricular nodal reentry tachycardia (AVNRT), non re-entrant junctional tachycardias with non-inducibility of the targeted tachycardia at end of procedure will be reported.
Up to 7 Days
SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line
기간: Up to 7 Days

Number of participants with Macro Re-entrant Atrial Tachycardia (MRAT) with complete bidirectional conduction block across the ablation line will be reported.
Up to 7 Days
SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway
기간: Up to 7 Days

Number of participants with atrioventricular reentry tachycardia (AVRT) with complete block of accessory pathway will be reported.
Up to 7 Days
VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure
기간: Up to 7 days

Number of participants with non-inducibility of the targeted ischemic or non-ischemic VT at end of procedure will be reported.
Up to 7 days
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant VT
기간: Up to 7 days

Number of participants with elimination of clinically relevant idiopathic VT will be reported. Clinically relevant: any spontaneous VT or any induced VT.
Up to 7 days
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs)
기간: Up to 7 days

Number of participants with elimination of clinically relevant idiopathic PVCs will be reported. Clinically relevant: any spontaneous PVC or any induced PVC; prior to treatment, PVCs would be deemed clinically relevant if they are present greater than (>) 20 percent (%) of daily heartbeat.
Up to 7 days

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs])
기간: Up to 365 Days

Number of participants with device and/or procedure-related Serious Adverse Events (SADEs) within 7 days (early-onset), >7-30 days (peri-procedural) and >30 days (late onset) following the initial study procedure will be reported.
Up to 365 Days
Number of Participants with Device and/or Procedure-Related Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs])
기간: Up to 365 Days

Number of participants with device and/or procedure-related non-serious adverse events (Non-serious ADEs) within 7 days (early-onset), >7-30 days (peri-procedural) and >30 days (Late Onset) following the initial study procedure will be reported.
Up to 365 Days
AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs)
기간: Up to 7 Days

Number of participants with Acute reconnection among all targeted PVs will be reported.
Up to 7 Days
SVT (MRAT): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure
기간: Up to 7 Days

Number of participants with MRAT with non-inducibility of the targeted tachycardia at end of procedure will be reported.
Up to 7 Days
SVT (AVNRT): Number of Participants with Elimination or Modification of Slow Pathway Conduction
기간: Up to 7 Days

Number of participants with AVNRT with elimination or modification of slow pathway conduction will be reported.
Up to 7 Days
VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of any VT at end of Procedure
기간: Up to 7 Days

Number of participants with non-inducibility of any VT (Ischemic or Non-ischemic) at end of procedure will be reported.
Up to 7 Days
VT (Ischemic or Non-ischemic): Number of Participants with Elimination of all Targeted Late Potentials and Local Abnormal Ventricular Activation (LAVAs) at end of Procedure
기간: Up to 7 Days

Number of participants with elimination of all targeted late potentials and local abnormal ventricular activation (LAVAs) at end of procedure will be reported.
Up to 7 Days
AF: Number of Participants with Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes
기간: From Day 91 to Day 365 (post-blanking)

Number of participants with freedom from documented (symptomatic and asymptomatic) AF, AT, AFL episodes (episodes greater than or equal to [>=] 30 seconds) post-blanking will be reported.
From Day 91 to Day 365 (post-blanking)
AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes
기간: From Day 91 to Day 365 (post-blanking)

Number of participants with freedom from documented symptomatic AF, AT, AFL episodes (episodes >= 30 seconds) post-blanking will be reported.
From Day 91 to Day 365 (post-blanking)
AF: Number of Participants with Repeated Ablation
기간: From Day 91 to Day 365 (post-blanking)

Number of participants with repeated ablation post-blanking will be reported.
From Day 91 to Day 365 (post-blanking)
AF: Number of Participants with Repeated Ablation with Pulmonary Vein (PV) Reconnection
기간: From Day 91 to Day 365 (post-blanking)

Number of participants with repeated ablation with PV reconnection post blanking will be reported.
From Day 91 to Day 365 (post-blanking)
SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT
기간: From Day 1 to Day 365

Number of participants with freedom from documented arrhythmia of the primary SVT (episodes >=30 seconds) will be reported.
From Day 1 to Day 365
SVT: Number of Participants with Freedom From Documented Arrhythmia of new SVT, not Targeted During Index Procedure
기간: From Day 1 to Day 365

Number of participants with freedom from documented arrhythmia of new SVT, not targeted during index procedure will be reported.
From Day 1 to Day 365
SVT: Number of Participants with Repeated Ablation
기간: From Day 1 to Day 365

Number of participants with repeated ablation will be reported.
From Day 1 to Day 365
VT: Number of Participants with Freedom From Documented Arrhythmia of the Clinically Relevant/Targeted VT
기간: From Day 1 to Day 365

Number of participants with freedom from documented arrhythmia of the clinically relevant /targeted VT (episodes >=30 seconds) will be reported.
From Day 1 to Day 365
VT: Number of Participants with Freedom From Documented Arrhythmia of new VT, not Targeted During Index Procedure
기간: From Day 1 to Day 365

Number of participants with freedom from documented arrhythmia of new VT, not targeted during index procedure will be reported.
From Day 1 to Day 365
VT: Number of Participants with Repeated Ablation
기간: From Day 1 to Day 365

Number of participants with repeated ablation will be reported.
From Day 1 to Day 365
VT: Number of Participants with All Cause and Cardiac Mortality
기간: Up to Day 365

Number of participants with all cause and cardiac mortality will be reported.
Up to Day 365
VT: Number of Participants with Heart Failure Hospitalization
기간: Up to Day 365

Number of participants with heart failure hospitalization will be reported.
Up to Day 365

기타 결과 측정

결과 측정
측정값 설명
기간
VARIPURE sub-study: Number of Participants With Coronary Spasm During Ablation
기간: Up to Day 365

Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with coronary spasm during ablation will be reported.
Up to Day 365
VARIPURE Sub-Study: Number of Participants With Vagal Response During Ablation
기간: Up to Day 365

Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with vagal response during ablation will be reported.
Up to Day 365
VARIPURE Sub-Study: Number of Participants With Acute Kidney Failure Post Ablation
기간: Up to Day 365

Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with acute kidney failure post ablation will be reported.
Up to Day 365
DUACURE Sub-Study: Number of Participants With Coronary Spasm During Ablation
기간: Up to Day 365

Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with coronary spasm during ablation will be reported.
Up to Day 365
DUACURE Sub-Study: Number of Participants With Vagal Response During Ablation
기간: Up to Day 365

Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with vagal response during ablation will be reported.
Up to Day 365
DUACURE Sub-Study: Number of Participants With Acute Kidney Failure Post Ablation
기간: Up to Day 365

Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with acute kidney failure post ablation will be reported.
Up to Day 365

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Biosense Webster, Inc.

수사관

  • 연구 책임자: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 2월 22일

기본 완료 (추정된)

2036년 12월 31일

연구 완료 (추정된)

2037년 12월 31일

연구 등록 날짜

최초 제출

2021년 2월 8일

QC 기준을 충족하는 최초 제출

2021년 2월 8일

처음 게시됨 (실제)

2021년 2월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BWI_2019_05

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다