Restoring Sinus Rhythm Using Dual-Shock Technique in Patients With Atrial Fibrillation (DUAL-SHOCK)
Restoring Sinus Rhythm Using DUAL-electrical SHOCK Technique: the DUAL-SHOCK Trial
The goal of this clinical trial is to assess the efficacy and acute safety of the dual electrical cardioversion (ECV) technique compared with the conventional ECV in patients with persistent atrial fibrillation. The main question it aims to answer are:
- Is dual ECV more effective than conventional ECV to achieve sinus rhythm restoration?
- Is dual ECV safe compared with conventional ECV?
- Which are the main factors associated with cardioversion success?
Researchers will compare a dual ECV technique with 400J with dual ECV with 200J and conventional ECV.
Participants will be randomized to one ECV configuration. The primary efficacy endpoint will be considered the percentage of patients with successful cardioversion with the first shock. The coprimary safety endpoint will be the occurrence of adverse events during ECV.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Martín Negreira-Caamaño, MD, PhD
- 전화번호: +34 916839360
- 이메일: martin.negcam@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Diagnosis of persistent AF.
- Effective anticoagulation for at least 3 weeks prior to the procedure or exclusion of intra-atrial thrombus by transesophageal echocardiography within the last 24 hours.
- Informed consent obtained.
Exclusion Criteria:
- Long-standing persistent atrial fibrillation (more than 1 year of uninterrupted AF rhythm).
- Emergency indication (hemodynamic instability).
- Cardiac defibrillation following catheter ablation procedures. Cardiac defibrillation performed during the same procedure will be permitted if it is carried out prior to ablation.
- Pregnancy.
- Age <18 years or legal incapacity.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Conventional Electrical Cardioversion
Conventional ECV with single pad configurataion in antero-lateral or antero-posterior location.
Energy deliver: 200J
|
Defibrillation pads will be placed in the anteroposterior or anterolateral position. An initial biphasic shock of 200 J will be delivered. If sinus rhythm is not restored, a second dual shock of 400 J (crossover) will be administered. The procedures will be performed in the designated area for such procedures at each center, under deep sedation in accordance with each center's standard protocols. The choice of medication used for sedation will be at the investigator's discretion. All shocks will be delivered using biphasic energy and ECG-synchronized. |
|
실험적: Dual-Shock 400J
ECV with dual shock technique.
Double pad configuration with electrodes both in antero-lateral and antero-posterior location.
Total energy deliver: 400J.
|
Two pairs of defibrillation pads connected to two different defibrillators will be used. One pair of pads will be placed in the anterolateral position and the second pair in the anteroposterior position. Both defibrillators will be programmed to deliver a biphasic shock of 100 J each (200 J group) or 200 J each (400 J group) simultaneously. The maximum number of CVE attempts per patient will be 3. The procedures will be performed in the designated area for such procedures at each center, under deep sedation in accordance with each center's standard protocols. The choice of medication used for sedation will be at the investigator's discretion. All shocks will be delivered using biphasic energy and synchronized with the QRS complex. |
|
실험적: Dual-Shock 200J
ECV with dual shock technique.
Double pad configuration with electrodes both in antero-lateral and antero-posterior location.
Total energy deliver: 200J.
|
Two pairs of defibrillation pads connected to two different defibrillators will be used. One pair of pads will be placed in the anterolateral position and the second pair in the anteroposterior position. Both defibrillators will be programmed to deliver a biphasic shock of 100 J each (200 J group) or 200 J each (400 J group) simultaneously. The maximum number of CVE attempts per patient will be 3. The procedures will be performed in the designated area for such procedures at each center, under deep sedation in accordance with each center's standard protocols. The choice of medication used for sedation will be at the investigator's discretion. All shocks will be delivered using biphasic energy and synchronized with the QRS complex. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock
기간: First minute after first shock delivery
|
Percentage of patients achieving sinus rhythm with the first shock deliver.
Three consecutive beats in sinus rhythm are neccesary to consider sinus rhythm achieved.
|
First minute after first shock delivery
|
|
Primary Safety Outcome - Adverse events during the procedure
기간: Before patient are discharged
|
Ocurrence of any complication during the ECV.
Arrhythmic recurrences of atrial fibrillation will not be considered as complications.
|
Before patient are discharged
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Procedural Sucess
기간: The end of the procedure
|
Percentage of patients achieving stable sinus rhythm after any number of shocks
|
The end of the procedure
|
|
Overall Intervention-Specific Success
기간: First minute after shock delivery
|
Number of successful shocks / Overall delivered shock within the same pad configuration.
|
First minute after shock delivery
|
|
Total Energy Delivered
기간: End of the procedure
|
Total energy administered (J) before the procedure is completed
|
End of the procedure
|
|
Sub-acute procedural success
기간: At 30 (25-35) days after the procedure
|
Percentage of patients in sinus rhythm at 30 days after the ECV
|
At 30 (25-35) days after the procedure
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
기타 연구 ID 번호
- 25-129
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
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