Tailored Treatment of Permanent Atrial Fibrillation (TTOP-AF)
2018年9月17日 更新者：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.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
210
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Arizona
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Scottsdale、Arizona、アメリカ、85251
- Arizona Arrhythmia Research Center
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California
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Los Angeles、California、アメリカ、90095
- UCLA Cardiac Arrhythmia Center
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Florida
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Jacksonville、Florida、アメリカ、32224
- Mayo Clinic Jacksonville
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Georgia
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Atlanta、Georgia、アメリカ、30309
- Piedmont Hospital
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Atlanta、Georgia、アメリカ、30308
- Emory Crawford Long Hospital
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Illinois
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Chicago、Illinois、アメリカ、60637
- University of Chicago
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- Krannert Institute of Cardiology
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Iowa
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Davenport、Iowa、アメリカ、52803
- Genesis Medical Center
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Des Moines、Iowa、アメリカ、50309
- Iowa Heart Center
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Maryland
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Baltimore、Maryland、アメリカ、21287
- Johns Hopkins Hospital
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Takoma Park、Maryland、アメリカ、20912
- Washington Adventist Hospital
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Brigham and Women's Hospital
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital Cardiac Arrhythmia
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Burlington、Massachusetts、アメリカ、01805
- Lahey Clinic
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan
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Grand Rapids、Michigan、アメリカ、49503
- Spectrum Health Research Department
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New York
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Rochester、New York、アメリカ、14642
- University of Rochester
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest University
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Ohio
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Columbus、Ohio、アメリカ、43210
- The Ohio State University
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Pennsylvania
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Erie、Pennsylvania、アメリカ、16502
- Consultants in Cardiovascular Diseases
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Texas
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Austin、Texas、アメリカ、78756
- Austin Heart
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Houston、Texas、アメリカ、77030
- Texas Heart Institute at St. Luke's Episcopal
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Virginia
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Norfolk、Virginia、アメリカ、23507
- Sentara Cardiovascular Research Institute
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Nieuwegein、オランダ
- St. Antonius Ziekenhuis
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：1
Ablation Management
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Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium.
Cardioversion could be used to restore sinus rhythm if needed.
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アクティブコンパレータ：2
Medical Management
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Chronic Effectiveness
時間枠：6 months
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The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included:
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6 months
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Acute Safety
時間枠：7 days
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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.
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7 days
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Chronic Safety
時間枠：6 months
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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.
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Acute Efficacy
時間枠：Procedure conclusion
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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:
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Procedure conclusion
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Improvement of Left Atrial Size at 6 Months Compared to Baseline.
時間枠：6 months
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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.
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6 months
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Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline.
時間枠：6 months
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Left ventricular ejection fraction (LVEF), as measured by transthoracic echocardiogram at baseline and 6 months in both the Ablation and Medical Management arms.
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6 months
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Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline.
時間枠：6 months
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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.
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6 months
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Improved Quality of Life Over 6 Months Compared to Baseline.
時間枠：6 months
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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.
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6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Abreu Filho CA, Lisboa LA, Dallan LA, Spina GS, Grinberg M, Scanavacca M, Sosa EA, Ramires JA, Oliveira SA. Effectiveness of the maze procedure using cooled-tip radiofrequency ablation in patients with permanent atrial fibrillation and rheumatic mitral valve disease. Circulation. 2005 Aug 30;112(9 Suppl):I20-5. doi: 10.1161/CIRCULATIONAHA.104.526301.
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便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2007年5月1日
一次修了 (実際)
2010年11月1日
研究の完了 (実際)
2010年11月1日
試験登録日
最初に提出
2007年8月8日
QC基準を満たした最初の提出物
2007年8月8日
最初の投稿 (見積もり)
2007年8月10日
学習記録の更新
投稿された最後の更新 (実際)
2018年10月16日
QC基準を満たした最後の更新が送信されました
2018年9月17日
最終確認日
2018年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Medtronic Cardiac Ablation Systemの臨床試験
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Medtronic Cardiac Rhythm and Heart Failure完了
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Uppsala University HospitalMedtronic; Swedish Heart Lung Foundationわからない
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Medtronic BRCMedtronic完了
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Newmarket Electrophysiology Research Group IncMedtronic完了
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Ohio State UniversityMedtronic募集
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Medtronic Vascular完了