- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01636518
Hybrid AF -- A Prospective Registry
Hybrid Procedure for the Treatment of Long Standing Persistent Atrial Fibrillation - A Prospective Registry
Atrial Fibrillation (AF) is a form of rapid irregular heart rhythm that starts in the upper chambers of the heart (called atria) and is often associated with many health problems. It can cause stroke, palpitations and heart failure. The management of long standing (chronic) AF may require additional medications and blood thinners, potentially for life. It may also require procedures where the heart is shocked with an electrical current to restore normal rhythm. Some patients require a procedure called radiofrequency ablation to address the arrhythmia.
The purpose of this registry is to collect information on patients undergoing this combination of procedures into a database, and to then use this information for scientific study to improve the treatment of atrial fibrillation.
연구 개요
연구 유형
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Documented effectiveness failure of at least one Vaughan-Williams Class III AAD
- Persistent AF as defined by the HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation
- Absence of significant structural heart disease as demonstrated by a transthoracic echocardiogram (TTE) of all four chambers of the heart, computed tomography (CT) scan or magnetic resonance imaging (MRI) scan within 6 months prior to enrollment
- Absence of left atrial thrombus as documented by an imaging study (e.g., TTE, transesophageal echocardiogram (TEE), thoracic CT scan, MRI, or left atrial angiography) within 30 days prior to procedure
Exclusion Criteria:
- History of longstanding persistent AF for more than 3 years
- Documented left atrial size of 60 mm or more
- Documented left ventricular ejection fraction (LVEF) less than 40%
- History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment
- Significant underlying structural heart disease requiring surgical or procedural intervention within the last six months of initial procedure
- Known contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy
- Other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis, etc.)
- Pregnancy, planned pregnancy (females of childbearing potential must have a negative pregnancy test prior to enrollment and agree not to become pregnant during the trial) or breastfeeding;
- Concomitant procedure planned
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Atrial Fibrillation
Patients with Atrial Fibrillation that undergo standard of care procedure at the University of Kansas Hospital
|
Standard of care procedure as determined by treating physician for Atrial Fibrillation
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Outcomes of patients with persistent Atrial Fibrillation who undergo the standard of care hybrid procedure
기간: 2 years
|
2 years
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center
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. .