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Tailored Treatment of Permanent Atrial Fibrillation (TTOP-AF)

2018년 9월 17일 업데이트: Medtronic Cardiac Rhythm and Heart Failure

Tailored Treatment of Permanent Atrial Fibrillation - TTOP-AF

The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

210

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 네덜란드
      • Nieuwegein, 네덜란드
        • St. Antonius Ziekenhuis
  • 미국
    • Arizona
      • Scottsdale, Arizona, 미국, 85251
        • Arizona Arrhythmia Research Center
    • California
      • Los Angeles, California, 미국, 90095
        • UCLA Cardiac Arrhythmia Center
    • Florida
      • Jacksonville, Florida, 미국, 32224
        • Mayo Clinic Jacksonville
    • Georgia
      • Atlanta, Georgia, 미국, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, 미국, 30308
        • Emory Crawford Long Hospital
    • Illinois
      • Chicago, Illinois, 미국, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, 미국, 46202
        • Krannert Institute of Cardiology
    • Iowa
      • Davenport, Iowa, 미국, 52803
        • Genesis Medical Center
      • Des Moines, Iowa, 미국, 50309
        • Iowa Heart Center
    • Maryland
      • Baltimore, Maryland, 미국, 21287
        • Johns Hopkins Hospital
      • Takoma Park, Maryland, 미국, 20912
        • Washington Adventist Hospital
    • Massachusetts
      • Boston, Massachusetts, 미국, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, 미국, 02114
        • Massachusetts General Hospital Cardiac Arrhythmia
      • Burlington, Massachusetts, 미국, 01805
        • Lahey Clinic
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109
        • University of Michigan
      • Grand Rapids, Michigan, 미국, 49503
        • Spectrum Health Research Department
    • New York
      • Rochester, New York, 미국, 14642
        • University of Rochester
    • North Carolina
      • Winston-Salem, North Carolina, 미국, 27157
        • Wake Forest University
    • Ohio
      • Columbus, Ohio, 미국, 43210
        • The Ohio State University
    • Pennsylvania
      • Erie, Pennsylvania, 미국, 16502
        • Consultants in Cardiovascular Diseases
    • Texas
      • Austin, Texas, 미국, 78756
        • Austin Heart
      • Houston, Texas, 미국, 77030
        • Texas Heart Institute at St. Luke's Episcopal
    • Virginia
      • Norfolk, Virginia, 미국, 23507
        • Sentara Cardiovascular Research Institute

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

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

INCLUSION CRITERIA:

  • History of symptomatic, continuous atrial fibrillation defined as: Continuous atrial fibrillation lasting greater than 1 year but less than 4 years or nonself-terminating atrial fibrillation, lasting greater than 7 days but no more than 1 year, with at least one failed direct current cardioversion. A failed cardioversion was defined as an unsuccessful cardioversion or one in which normal sinus rhythm was established but not maintained beyond 7 days.
  • Atrial fibrillation symptoms included the following: palpitations, fatigue,exertional dyspnea, exercise intolerance
  • Age between 18 and 70 years
  • Failure of at least one Class I or III rhythm control drug
  • Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.

EXCLUSION CRITERIA:

  • Structural heart disease of clinical significance including:

    • Previous cardiac surgery (excluding coronary artery bypass graft and mitral valve repair)
    • Symptoms of congestive heart failure including, but not limited to, New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented ejection fraction <40% measured by acceptable cardiac testing
    • Left atrial diameter >55 mm
    • Moderate to severe mitral or aortic valvular heart disease
    • Stable/unstable angina or ongoing myocardial ischemia
    • Myocardial infarction (MI) within 3 months of enrollment
    • Congenital heart disease (not including atrial septal defect or patent foramen ovale without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
    • Prior atrial septal defect of patent foramen ovale closure with a device using a percutaneous approach
    • Hypertrophic cardiomyopathy (left ventricular septal wall thickness >1.5 cm)
    • Pulmonary hypertension (mean or systolic pulmonary artery pressure >50 mm Hg on Doppler echo)
  • Any prior ablation for atrial fibrillation
  • Enrollment in any other ongoing arrhythmia study
  • Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study
  • Active infection or sepsis
  • Any history of cerebral vascular disease including stroke or transient ischemic attacks
  • Pregnancy or lactation
  • Left atrial thrombus at the time of ablation
  • Untreatable allergy to contrast media
  • Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
  • History of blood clotting (bleeding or thrombotic) abnormalities
  • Known sensitivities to heparin or warfarin
  • Severe chronic obstructive pulmonary disease (defined as forced expiratory volume 1 (FEV1) <1)
  • Severe co-morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 1
Ablation Management
절차: Medtronic Cardiac Ablation System
Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium. Cardioversion could be used to restore sinus rhythm if needed.
활성 비교기: 2
Medical Management
의약품: Class I or III Antiarrhythmic Medications
Arm 2 (Medical Management): Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Chronic Effectiveness
기간: 6 months

The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included:

  1. A 90% reduction in clinically significant atrial fibrillation from baseline to the 6 month time point based on a Holter recording. Clinically significant atrial fibrillation was defined as sustained atrial fibrillation lasting more than 10 minutes.
  2. The subject was off all antiarrhythmic drugs at 6 months (Ablation Management arm only)
  3. The Investigator judged all procedures to be acutely successful (Ablation Management arm only).
6 months
Acute Safety
기간: 7 days
The primary endpoint for acute safety was a success/failure variable calculated for each subject in Ablation Management at the 7 day post-procedure time point. Any subject with at least one adverse event adjudicated by the Data Safety Monitoring Board as both serious and either probably or definitely procedure and/or device-related occurring within 7 days of the ablation procedure was considered an acute safety failure, regardless of whether the event occurred following the index or retreatment ablation procedure.
7 days
Chronic Safety
기간: 6 months
The primary endpoint for chronic safety was a success/failure variable calculated for each subject at 6 months. Any subject that had at least one adverse event that met designated seriousness and relatedness criteria for the particular treatment group as adjudicated by the Data Safety Monitoring Board was considered a chronic safety failure. Adverse events in Ablation Management that were acute (≤7 days) were not included in the chronic safety primary endpoint. Given the disparity in the length of time at risk between treatment arms,the Chronic Safety endpoint was not statistically powered.
6 months

2차 결과 측정

결과 측정
측정값 설명
기간
Acute Efficacy
기간: Procedure conclusion

A treatment success/failure up to the conclusion of the procedure for each subject in Ablation Management. A subject was considered successfully treated if the following were true:

  • Medtronic ablation catheters were used to achieve procedure success.
  • All accessible pulmonary veins were isolated.
  • At least 50% reduction of complex fractionated atrial electrograms mapped and ablated with Medtronic ablation catheters.
  • Sinus rhythm was achieved upon leaving the electrophysiology lab (±cardioversion).
Procedure conclusion
Improvement of Left Atrial Size at 6 Months Compared to Baseline.
기간: 6 months
Left atrial diameter (LAD), as measured by transthoracic echocardiogram (TTE) looking at the longitudinal long axis at baseline and at the 6 month follow-up visit in both the Ablation and Medical Management arms.
6 months
Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline.
기간: 6 months
Left ventricular ejection fraction (LVEF), as measured by transthoracic echocardiogram at baseline and 6 months in both the Ablation and Medical Management arms.
6 months
Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline.
기간: 6 months
The severity of subject's atrial fibrillation related symptoms on a scale from 1 (no symptoms) to 5 (most severe). The symptoms included palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and lack of energy during exertion or exercise. The scores were tabulated at the 1, 3 and 6 month follow-up visits. Scores could range from 5 to 25, indicating a spectrum of subject status from asymptomatic to severely symptomatic.
6 months
Improved Quality of Life Over 6 Months Compared to Baseline.
기간: 6 months
The SF-36 questionnaire was administered to subjects at baseline, 1, 3 and 6 month visits. The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based Physical Component Score and Mental Component Score. The possible range for Physical Component Score and Mental Component Score is 0 to 100. The higher score, the better quality of life.
6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Medtronic Cardiac Rhythm and Heart Failure

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

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

2007년 5월 1일

기본 완료 (실제)

2010년 11월 1일

연구 완료 (실제)

2010년 11월 1일

연구 등록 날짜

최초 제출

2007년 8월 8일

QC 기준을 충족하는 최초 제출

2007년 8월 8일

처음 게시됨 (추정)

2007년 8월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 10월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 9월 17일

마지막으로 확인됨

2018년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • AFI-30

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. .

심방세동에 대한 임상 시험

Medtronic Cardiac Ablation System에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Tunisia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다