European CURE-AF Study
European CURE-AF Study - Concomitant Utilization of Radiofrequency Energy for Atrial Fibrillation
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Hans Nissens Gate 3
-
Trondheim, Hans Nissens Gate 3, 노르웨이, 7018
- St. Elizabeth Heart Center - Department of Cardiothoracic Surgery
-
-
Jonas Liesvei 65
-
Bergen, Jonas Liesvei 65, 노르웨이, 5021
- Haukeland University Hospital - Department of Cardiothoracic Surgery
-
-
-
-
Beneke Str. 2-8
-
Bad Nauheim, Beneke Str. 2-8, 독일, 61231
- Kerckhoff Clinic - Department of Thoracic & Cardiovascular Surgery
-
-
Leipziger Strasse 50
-
Cottbus, Leipziger Strasse 50, 독일, 03048
- Heart Center Cottbus - Department of Cardiac Surgery
-
-
-
-
Ul. Banacha 1a
-
Warsaw, Ul. Banacha 1a, 폴란드, 02-097
- Public Central Teaching Hospital - Department of Cardiac Surgery
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Patients must meet all of the following criteria to be enrolled in the study:
- Documented history of AF a For inclusion in permanent AF arm: Patients must have a documented history of permanent AF (cardioversion failure) as defined by the ACC/AHA/ESC Guidelines; Documentation of AF must include one or more chart references to AF and/or one or more ECG's with AF prior to the patient's surgery. Other supporting information could include references to cardioversion attempts using either drugs or electrical shock. b For inclusion in persistent AF arm: Patients must have a documented history of persistent AF as defined by the ACC/AHA/ESC Guidelines: characterized as episodes of non-self-terminating atrial fibrillation that usually lasts more than 7 days
- Concomitant indication (other than AF) for open-heart surgery for one or more of the following:
a Mitral valve repair or replacement, b Aortic valve repair or replacement, c Tricuspid valve repair or replacement, d ASD repair, e PFO closure, or f CABG procedures; 3 Able to take the anticoagulant warfarin or other ACC/AHA/ESC-recommended anticoagulant medication; 4 Greater than or equal to 18 years of age; 5 Able and willing to comply with study requirements by signing a Patient Informed Consent form.
Exclusion Criteria:
Patients who meet any of the following criteria may not be enrolled in the study:
1 Wolff-Parkinson-White syndrome, 2 NYHA functional class = IV, 3 Left ventricular ejection fraction ≤ 30%, 4 Left atrial diameter > 7.0 cm, 5. Need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery, 6 Preoperative need for an intra-aortic balloon pump or intravenous inotropes, 7 Previous atrial ablation, AV-nodal ablation, or surgical Maze procedure, 8 Contraindication for anticoagulation therapy, 9 Current diagnosis of active systemic infection, 10 Renal failure requiring dialysis or hepatic failure, 11 Documented myocardial infarction 6 weeks prior to study enrollment, 12 Life expectancy of less than one year, or 13 Pregnancy or desire to be pregnant within 12-months of the study treatment.
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 |
|---|---|
|
실험적: CURE AF
|
이 조사는 개심 수술과 수정된 Maze III 절차를 사용하는 Cardioblate 수술 절제 시스템이 필요한 심방세동 환자의 결과를 평가하는 전향적 비무작위 다기관 임상 시험입니다.
시험 모집단에는 판막 교체 또는 수리, 심방 중격 결손(ASD) 수리, 난원공 개존(PFO) 폐쇄 또는 관상동맥 우회술(CABG) 절차가 필요한 환자가 포함됩니다.
This investigation is a prospective, non-randomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure.
The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Permanent AF Arm
기간: 24-hour Holter recording at 6 months follow-up
|
Primary efficacy endpoint- The percent of patients free of AF, off Class I or III antiarrhythmic drugs and not having received additional ablation therapy, as determined by a 24-hour Holter recording at 6 months follow-up.
|
24-hour Holter recording at 6 months follow-up
|
|
Persistent AF Arm
기간: 24-hour Holter recording at 9 months follow-up.
|
The percent of patients free of AF, off Class I or III antiarrhythmic drugs and not having received additional ablation therapy, as determined by a 24-hour Holter recording at 9 months follow-up.
|
24-hour Holter recording at 9 months follow-up.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Permanent AF Arm
기간: 24 hours
|
Secondary efficacy endpoints - 24-hour Holter recording, b) improvement in left ventricular ejection fraction and c) left atrial transport function as evidenced by the presence of an A wave at 6 months follow-up.
|
24 hours
|
|
Persistent AF Arm
기간: 24-hour Holter recording at 9 months follow-up.
|
Secondary efficacy endpoints - a) The percent of patients free of AF, regardless of Class I or III antiarrhythmic drug use and not having received additional ablation therapy, as determined by a 24-hour Holter recording, b) improvement in left ventricular ejection fraction and c) left atrial transport function as evidenced by the presence of an A wave at 9 months follow-up.
|
24-hour Holter recording at 9 months follow-up.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .