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

지속성 심방세동 환자를 치료하기 위한 VARIPULSE PFA(펄스 전계 절제) 카테터 및 FARAWAVE PFA 카테터 연구 (PERSIGMA RCT)

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

지속성 심방세동 환자 치료에서 VARIPULSE™ PFA 카테터와 FARAWAVE™ PFA 카테터의 안전성 및 효과 비교: 무작위 대조 시험

The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

566

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • Arkansas
      • Jonesboro, Arkansas, 미국, 72401
        • 모병
        • Arrhythmia Research Group
    • California
      • Fountain Valley, California, 미국, 92708
        • 모병
        • OC Medical Center
      • Ventura, California, 미국, 93003
        • 모병
        • Community Memorial Hospital
    • Florida
      • Jacksonville, Florida, 미국, 32204
        • 모병
        • St. Vincents Medical Center
      • Miami, Florida, 미국, 33133
        • 모병
        • HCA Florida Mercy Hospital
      • Naples, Florida, 미국, 34102
        • 모병
        • NCH Healthcare
    • Georgia
      • Atlanta, Georgia, 미국, 30342
        • 모병
        • Emory Saint Joseph's Hospital
      • Savannah, Georgia, 미국, 31404
        • 모병
        • Memorial Health University Medical Center
    • Kentucky
      • Lexington, Kentucky, 미국, 40503
        • 모병
        • Baptist Health Lexington
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • 모병
        • Massachusetts General Hospital
      • Boston, Massachusetts, 미국, 02215
        • 모병
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ypsilanti, Michigan, 미국, 48197
        • 모병
        • Trinity Health Michigan Heart - Ann Arbor Campus
    • New Jersey
      • New Brunswick, New Jersey, 미국, 08901
        • 모병
        • Rutgers Robert Wood Johnson Medical School
    • New York
      • New York, New York, 미국, 10075
        • 모병
        • Lenox Hill Hospital
      • Rochester, New York, 미국, 14621
        • 모병
        • Rochester General Hospital
      • The Bronx, New York, 미국, 10467
        • 모병
        • Montefiore Medical Center
    • North Carolina
      • Raleigh, North Carolina, 미국, 27610
        • 모병
        • WakeMed Hospital
    • Texas
      • Austin, Texas, 미국, 78705
        • 모병
        • Texas Cardiac Arrhythmia Research Foundation
      • Plano, Texas, 미국, 75093
        • 모병
        • Baylor Research Institute
    • Utah
      • Murray, Utah, 미국, 84107
        • 모병
        • Intermountain Medical Center

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

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion criteria:

  • Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days and less than 365 days in duration documented by: i. A physician's note documenting diagnosis of symptomatic PsAF as defined above and ii. Two electrocardiograms showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than [>] 365 days prior to enrollment) or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days
  • Participant is aged 18 - 80 years at the time of informed consent
  • Participant is willing and capable of providing informed consent
  • Participant is able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion criteria:

  • Participant has continuous AF > 365 days (longstanding persistent AF)
  • Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)
  • Participant has had previous surgical or catheter ablation for AF
  • Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
  • Participant has severe dilatation of the LA (LAD > 50 millimeters [mm]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment
  • Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure
  • Participant has severely compromised Left Ventricular Ejection Fraction (LVEF less than [<] 40%) confirmed by imaging performed within 180 days prior to enrollment
  • Participant has uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
  • Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)
  • Participant has had a thromboembolic event (including TIA) within the past 180 days prior to enrollment
  • Participant has had a percutaneous coronary intervention or acute MI within past 60 days prior to enrollment
  • Participant has had coronary artery bypass grafting (CABG) surgery within the past 180 days prior to enrollment
  • Participant has had valvular cardiac surgical/percutaneous procedure (for example, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)
  • Participant has unstable angina within past 6 months prior to enrollment
  • Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure
  • Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
  • Participant has a significant congenital anomaly (for example, atrial septal defects [ASDs]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study
  • Participant has an existing diagnosis of pulmonary vein stenosis (PVS)
  • Participant has a pre-existing hemi-diaphragmatic paralysis
  • Participant has an acute illness, active systemic infection, or sepsis
  • Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
  • Participant has severe mitral regurgitation (regurgitant volume greater than or equal to [>=] 60 milliliters [mL]/beat, regurgitant fraction >= 50 percent [%], and/or effective regurgitant orifice area >= 0.40 square centimeter [cm^2])
  • Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, etcetra.) and/or a double-coiled implantable cardioverter-defibrillators (ICD), (this exclusion does not include coronary stents, implanted pacemakers, single-coiled ICD and implantable loop recorders [ILR])
  • Participant has a condition that precludes vascular access (such as inferior vena cava [IVC] filter)
  • Participant is currently enrolled in an investigational study evaluating another device or drug
  • Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation
  • Participant has a life expectancy less than 365 days

For magnetic resonance imaging (MRI) subset:

  • Contraindication to use of contrast agents for MRI such as advanced renal disease etcetera
  • Presence of iron-containing metal fragments in the body that renders the participant contraindicated for an MRI
  • Unresolved pre-existing neurological deficit

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: VARIPULSE Pulsed Field Ablation (PFA) Catheter

Participants with persistent atrial fibrillation (PsAF) undergoing catheter ablation will undergo the ablation procedure with VARIPULSE catheter, and will be followed for up to 12 months post procedure. Eligible participants may enter an magnetic resonance imaging (MRI) subset and undergo MRI assessments at baseline and post-ablation procedure.
장치: VARIPULSE Catheter

Pulsed Field Ablation using the VARIPULSE catheter.
활성 비교기: FARAWAVE PFA Catheter

Participants with PsAF undergoing catheter ablation will undergo the ablation procedure with FARAWAVE catheter, and will be followed for up to 12 months post procedure. Eligible participants may enter an MRI subset and undergo MRI assessments at baseline and post-ablation procedure.
장치: FARAWAVE Catheter

Pulsed field ablation using the FARAWAVE catheter.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Occurrence of Early Onset Primary Adverse Events (PAEs)
기간: Up to 7 days post-index procedure

PAEs that include early onset AEs such as esophageal perforating complications, phrenic nerve paralysis (PNP; permanent), cardiac tamponade/perforation, pulmonary vein stenosis (PVS), death (device or procedure related), stroke/ cerebrovascular accident (CVA), major vascular access, complication/bleeding, thromboembolism, myocardial infarction (MI), transient ischemic attack (TIA), pericarditis, pulmonary edema (respiratory insufficiency), heart block, and vagal nerve injury/ gastroparesis.
Up to 7 days post-index procedure
Time to Occurrence of Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
기간: Day 61 and onward

Time to occurrence of documented (symptomatic and asymptomatic) atrial tachyarrhythmia (atrial fibrillation [AF], atrial tachycardia [AT] or atrial flutter [AFL] of unknown origin) episodes based on electrocardiographic data (12-Lead Electrocardiogram (ECG) or greater than equal to (>=) 30 seconds on sponsor provided Cardiac Event Monitor (CEM) or Patch arrhythmia monitor) during the effectiveness evaluation period or acute procedural failure, repeat ablation failure, surgical treatment for AF/AT/AFL, non-study catheter (NSC) failure, antiarrhythmic drug (AAD) failure and any direct current cardioversion (DCCV) procedure.
Day 61 and onward

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Quality of life, As Measured by the Total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score
기간: Baseline and at 6 months post procedure

The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms.
Baseline and at 6 months post procedure

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.

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)

2026년 4월 2일

기본 완료 (추정된)

2028년 5월 31일

연구 완료 (추정된)

2028년 5월 31일

연구 등록 날짜

최초 제출

2026년 4월 6일

QC 기준을 충족하는 최초 제출

2026년 4월 6일

처음 게시됨 (실제)

2026년 4월 13일

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

  • BWI202516

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

The data sharing policy of Johnson & Johnson MedTech is available at 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. .

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