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Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation (FARADIGM)

2026년 8월 26일 업데이트: Boston Scientific Corporation

Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation - A Global Prospective Single Arm Study

The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). The main question it aims to answer is:

Is the FARAFLEX Mapping and PFA System a safe and effective treatment for patients?

Participants will undergo an ablation procedure using the FARAFLEX Mapping and PFA System.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

571

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
    • Georgia
      • Atlanta, Georgia, 미국, 30342
        • 모병
        • Emory Saint Joseph's Hospital
        • 수석 연구원:
          • David DeLurgio
        • 연락하다:
    • New York
      • New York, New York, 미국, 10029
        • 모병
        • Mount Sinai Medical Center-Hospital
        • 수석 연구원:
          • Mohit Turagam
        • 연락하다:
    • Ohio
      • Columbus, Ohio, 미국, 43214
        • 모병
        • OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
        • 수석 연구원:
          • Auroa Badin
        • 연락하다:
    • Pennsylvania
      • Mechanicsburg, Pennsylvania, 미국, 17050
        • 모병
        • Pinnacle Health at Harrisburg Hospital - UPMC Pinnacle
        • 연락하다:
        • 수석 연구원:
          • Patel Chinmay
    • Texas
      • Austin, Texas, 미국, 78705
      • Tyler, Texas, 미국, 75701
        • 모병
        • Christus Trinity Mother Frances Health System-Hospital
        • 수석 연구원:
          • Stanislav Weiner
        • 연락하다:
  • 벨기에
      • Bruges, 벨기에, B-8000
  • 아일랜드
    • Dublin
      • Dublin, Dublin, 아일랜드, D07 RD8P

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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. At least 18 years old (or older if required by local law)
  2. Symptomatic, documented, drug-refractory paroxysmal or persistent atrial fibrillation (AF).
  3. Willing and capable of providing written informed consent
  4. Willing and able to comply with all follow-up assessments and study procedures at an approved investigational site

Exclusion Criteria:

  1. Any of the following atrial conditions:

    1. Left atrial anteroposterior diameter of at least 5.5 cm, or if not available, non-indexed volume greater than 100 mL
    2. Any prior atrial endocardial, epicardial, or surgical ablation for atrial arrhythmia (excluding right-sided Supraventricular Tachycardia (SVT) or Cavo-Tricuspid Isthmus (CTI)-dependent flutter)
    3. Any prior atrial surgery
    4. Current atrial myxoma
    5. Pulmonary vein abnormality, stenosis, or prior stenting (common and middle pulmonary veins allowed)
    6. Current left atrial thrombus

  2. Any of the following cardiovascular conditions:

    1. History of sustained ventricular tachycardia or ventricular fibrillation
    2. Atrial fibrillation secondary to reversible or non-cardiac causes (e.g., electrolyte imbalance, thyroid disease, alcohol)

    3. Presence of any of the following cardiac devices or implants:

      • Current or anticipated pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device
      • Current implantable loop recorder other than LUX-Dx
      • Prior interatrial baffle or septal closure device/patch (Patent Foramen Ovale (PFO)or Atrial Septal Defect (ASD))
      • Left atrial appendage closure or occlusion device

    4. Clinically significant valvular disease, including:

      • Any cardiac valve prosthesis, ring, repair, or clip
      • Moderate to severe mitral stenosis
      • Moderate to severe aortic stenosis
      • Severe mitral regurgitation
      • Severe tricuspid regurgitation
    5. Hypertrophic or amyloid cardiomyopathy
    6. Presence of Inferior Vena Cava (IVC) filter, inability to obtain vascular access, or contraindication to femoral access
    7. Awaiting cardiac transplantation or other cardiac surgery within 12 months (left atrial appendage closure/occlusion procedures allowed no less than (≥) 60 days after index procedure)
    8. Severe right ventricular dysfunction per investigator assessment

  3. Any of the following congenital conditions:

    1. Congenital heart disease with clinically significant residual anatomic or conduction abnormalities, or channelopathies
    2. Known congenital methemoglobinemia
    3. Known G6PD deficiency

  4. Any of the following medical history conditions:

    1. Solid organ or hematologic transplant, or under evaluation for transplant
    2. History or current evidence of hemi-diaphragmatic paralysis or paresis
    3. Prinzmetal angina or severe non-revascularizable coronary disease
    4. Known coagulopathy or bleeding disorder
    5. Renal insufficiency, history of dialysis, or renal transplant
    6. Known allergic reaction to nitroglycerin (excluding hypotension)
    7. Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure
    8. Active spinal cord stimulator

  5. Any of the following baseline conditions:

    1. NYHA Class III or IV heart failure
    2. Left ventricular ejection fraction (LVEF) less than 40% within 12 months
    3. CHA2DS2-VASc score greater than or equal to 5
    4. Body mass index (BMI) greater than 45.0
    5. Contraindication to or unwillingness to use systemic anticoagulation peri-procedurally
    6. Pregnant or lactating at time of procedure
    7. Severe lung disease, pulmonary hypertension, or oxygen-dependent lung disease
    8. Active malignancy (excluding squamous cell carcinoma)
    9. Clinically significant gastrointestinal disease (e.g., severe or erosive esophagitis, uncontrolled reflux, gastroparesis, esophageal candidiasis, active gastroduodenal ulceration)
    10. Known Active systemic infection
    11. Life expectancy of less than 1 year
    12. Concurrent enrollment in another investigational study or registry that may interfere with this study (exceptions include mandatory governmental registries or purely observational registries with sponsor approval)

  6. Any of the following events within 90 days prior to consent:

    1. Myocardial infarction, unstable angina, or coronary intervention
    2. Pericarditis or symptomatic pericardial effusion
    3. Gastrointestinal bleeding
    4. Cardiac surgery
    5. Stroke, Transient Ischemic Attack (TIA), or intracranial bleeding
    6. Any active non-neurologic thrombus and/or thromboembolic event
    7. Carotid stenting or endarterectomy
    8. Heart failure hospitalization
    9. Uncontrolled diabetes mellitus or HbA1c greater than 8.0%

  7. Other conditions:

    1. Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted ICM from the LUX-Dx family of devices
    2. Any medical condition that, in the investigator's opinion, would interfere with study participation, increase risk, or affect data interpretation

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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: FARAFLEX Mapping and Pulsed Field Ablation (PFA) System
Participants undergo a catheter procedure using the FARAFLEX Mapping and Pulsed Field Ablation (PFA) System to treat atrial fibrillation. The catheter is used to map the heart's electrical signals and deliver pulsed field ablation therapy.
장치: FARAFLEX Mapping and Pulsed Field Ablation (PFA) System
Catheter used to perform cardiac electrophysiological mapping and deliver cardiac tissue ablation therapy for the treatment of Atrial Fibrillation.
다른 이름들:
  • FARAFLEX Mapping and Pulsed Field Ablation (PFA) Catheter
  • FARAFLEX Catheter

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Proportion of Treatment Subjects and Attempt Subjects with device- or procedure-related defined Composite Serious Adverse Events, assessed through Day 60 following the index procedure.
기간: After the index procedure, rescheduled index procedure, or first re-ablation performed with the FARAFLEX (Day 0) through Day 60
Occurrence of defined Composite Serious Adverse Events after the procedure through Day 60.
After the index procedure, rescheduled index procedure, or first re-ablation performed with the FARAFLEX (Day 0) through Day 60
The primary effectiveness endpoint (PEE) is the proportion of Treatment Subjects with Treatment Success through the Day 365 Assessment.
기간: Day 0 through the Day 365 Assessment

Acute Procedural Success defined as Pulmonary Vein (PV) Isolation and Chronic Success. Chronic Success is defined as freedom from the following after the Blanking Period (60 days):

  • Arrhythmia: Occurrence of any Detectable Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT)
  • Re-ablation: Any re-ablation for Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT)
  • Cardioversion: Any electrical cardioversion for Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT)
  • Antiarrhythmic Drug (AAD) Use: dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new AAD.
Day 0 through the Day 365 Assessment

2차 결과 측정

결과 측정
측정값 설명
기간
Atrial Arrhythmia Burden Success Endpoint
기간: Post-blanking period (Day 60) through 6 months (Day 180)
Atrial Arrhythmia Burden Success is defined as the proportion of Treatment subjects with atrial arrhythmia burden less than or equal to 0.1% in the time period post-blanking period through 6 months, as measured by LUX-Dx.
Post-blanking period (Day 60) through 6 months (Day 180)
Cavo-Tricuspid Isthmus (CTI) Ablation - Acute Procedural Endpoint
기간: Index Ablation Procedure
Defined as the proportion of Treatment Subjects who underwent a Cavo-Tricuspid Isthmus (CTI) ablation during the Index Procedure, regardless of the atrial fibrillation cohort, with absence of conduction through the cavo-tricuspid isthmus in both directions (bidirectional block), achieved with the FARAFLEX™ Mapping and PFA Catheter only, and confirmed prior to the end of the Index Ablation Procedure.
Index Ablation Procedure

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boston Scientific Corporation

수사관

  • 수석 연구원: Andrea Natale, MD, Texas Cardiac Arrhythmia Research Foundation

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 7월 7일

기본 완료 (추정된)

2028년 7월 20일

연구 완료 (추정된)

2030년 1월 1일

연구 등록 날짜

최초 제출

2026년 5월 4일

QC 기준을 충족하는 최초 제출

2026년 5월 4일

처음 게시됨 (실제)

2026년 5월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 26일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PF314

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