FIRM as a Stand-alone Procedure in the Treatment of Atrial Fibrillation
Focal Impulse and Rotor Modulation (FIRM) as a Stand-alone Procedure in the Treatment of Atrial Fibrillation
연구 개요
상세 설명
After a pilot/implementation study consisting of 10 patients with paroxysmal atrial fibrillation (AF); 20 patients with paroxysmal AF will be included in a within-patient trial. This study will be followed by a similar comparison in 20 patients with persistent or longstanding persistent AF.
The AF driving sources will be visualized by a novel sequential bi-atrial panoramic contact mapping technique. Unipolar signals will be recorded by a 64-polar basket catheter (FIRMap®, Topera. Inc.), then processed and the activation patterns visualized (RhythmView® 3D Electrophysiologic Mapping System, Topera, Inc.).
Focal impulse and rotor modulation (FIRM) will then be performed with standard irrigated radio frequency catheter ablation until rotor or focal impulse elimination is confirmed by repeat FIRM mapping.
Treatment efficacy will be assessed with continuous heart rhythm monitors (Reveal XT®, Medtronic, Minneapolis, USA) implanted 3 months prior to ablation, and freedom from AF defined as AF burden <1% at follow-up at 12, 24 and 30 months.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Oslo, 노르웨이
- Dept. of Cardiology, Rikshospitalet - Oslo University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Paroxysmal atrial fibrillation despite of at least one Class I or Class III antiarrhythmic drug and/or previous conventional ablation (pulmonary vein isolation).
- At least one episode of paroxysmal atrial fibrillation should be documented by rhythm strip, ECG or implanted monitor during the last 6 months prior to ablation.
Exclusion Criteria:
- Significant structural heart disease (including symptomatic coronary heart disease; prosthetic mitral or tricuspid valve; congenital heart disease where abnormality or its correction prohibits or increases the risk of ablation).
- Intracardiac thrombus, tumor or dense contrast on TEE.
- Contraindication to anticoagulant therapy (heparin, warfarin, dabigatran and rivaroxaban).
- Anaphylactic allergy to contrast media.
- Poor general health resulting from other disease.
- Inability or refusal to provide written informed consent for the study.
공부 계획
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 |
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실험적: FIRM ablation
The first part of this within-patient trial investigate the efficacy of focal impulse and rotor modulation in 20 patients with paroxysmal atrial fibrillation, evaluated by continuous pre- and post-procedural heart rhythm monitoring. The second part consists of 20 patients with persistent or longstanding persistent atrial fibrillation following the same scheme. |
Radiofrequency catheter ablation of atrial fibrillation driving sources detected by sequential bi-atrial panoramic contact mapping.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Single procedure freedom from atrial fibrillation (AF) at 12 months.
기간: 12 months.
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Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
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12 months.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Single procedure freedom from atrial fibrillation (AF) at 24 months.
기간: 24 months.
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Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
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24 months.
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Single procedure freedom from atrial fibrillation (AF) at 30 months.
기간: 30 months.
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Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
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30 months.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Cumulative freedom from atrial fibrillation (AF) (multi-procedure).
기간: 30 months.
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Cumulative freedom from AF (multi-procedure) measured from final study.
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30 months.
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Major procedure related events.
기간: 0 to 12 months.
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Cardiac tamponade/perforation; stroke; transient ischemic attack; bleeding; vascular access complications; injury to the esophagus/phrenic or vagal nerve etc.
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0 to 12 months.
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Number of rotors identified and percentage eliminated on remap.
기간: Procedural.
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Number of rotors identified and percentage eliminated on remap will be evaluated during the procedure.
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Procedural.
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Quality of life (QOL).
기간: 12 months.
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QOL will be evaluated by the SF-36 health survey (Norwegian version) pre- and 12 months post ablation.
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12 months.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Rolf Franck Berntsen, MD, PhD, Dept. of Cardiology, Rikshospitalet - Oslo University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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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