Ablation of the Pulmonary Veins for Paroxysmal Afib (MAP-PAF)
2018年9月17日 更新者：Medtronic Cardiac Rhythm and Heart Failure
Multi-Array Ablation of the Pulmonary Veins for Paroxysmal Atrial Fibrillation
The purpose of this trial was to investigate and confirm the safety, efficacy, and efficiency of the Ablation Frontiers® Cardiac Ablation System when used in the treatment of paroxysmal atrial fibrillation.
(PAF)
調査の概要
詳細な説明
This trial was a non-randomized, multi-center, prospective study of subjects with symptomatic, paroxysmal atrial fibrillation (PAF).
The purpose of this study was to investigate and confirm the safety, efficacy and efficiency of the Medtronic Ablation Frontiers® Cardiac Ablation System when used for the treatment of paroxysmal AF.
The trial was conducted over a 2 year period with enrollment occurring between 4 October 2007 and 1 December 2008.
研究の種類
介入
入学 (実際)
55
段階
- フェーズ 4
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。
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 paroxysmal atrial fibrillation defined as:
- Self terminating AF lasting no more than 7 days
- AF events demostrating spontaneous conversion back to sinus rhythm
- Documentation of one or more events with PAF tracings by ECG, event recordings, pacemaker strips or monitor rhythm strips within the past year
- AF symptoms defined as the manisfestation of any of the following: Palpitations, Fatigue, Exertional dyspnea, effort intolerance
- Age between 18 and 70
- 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
- Prior ablation for arrhythmias other than AF within the past three months
- Prior left sided AF ablation
- Enrollment in any other ongoing arrhythmia study protocol
- Any ventricular tachyarrhythmias 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 TIAs
- Pregnancy or lactation
- 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 COPD (identified by an FEV1 < 1)
- Severe co morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
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：なし
- 介入モデル：単一グループの割り当て
- 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：Ablated Patients
Patients with a history of symptomatic paroxysmal (self-terminating) AF and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study.
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Patients with a history of symptomatic paroxysmal (self-terminating) AF and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study.
他の名前：
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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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Number of Participants With Successful Pulmonary Vein Isolation
時間枠：6 months
|
Acute effectiveness was defined as successful isolation of all pulmonary veins.
Pulmonary vein isolation was documented by the absence of pulmonary vein potentials when assessed by electrogram tracings in sinus rhythm using the PVAC catheter.
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6 months
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Chronic Effectiveness
時間枠：6 months
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The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit.
In order to be classified as a chronic success, all subjects were required to meet the following criteria: Absence of clinically significant AF (greater than 60 seconds) or left atrial tachycardia recorded on a 7-day Holter, absence of symptomatic AF after a 3 month blanking period, off all Class I and III AADs at 6 months.
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6 months
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Acute Safety
時間枠：7 days post procedure
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The Acute Safety Endpoint was defined as the proportion of subjects with Serious Adverse Events (SAEs) that were procedure- and/or device-related within 7 days after the ablation procedure.
The relatedness of each event was assessed by the investigator at each site.
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7 days post procedure
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Chronic Safety
時間枠：7 day post procedure to 6 months
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The Chronic Safety Endpoint was the proportion of subjects with serious procedure- and/or device-related events in the 7 day to 6 month follow-up period post-ablation.
The relatedness of each event was assessed by the investigator at each site.
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7 day post procedure to 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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Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months
時間枠：6 Months
|
Subjects rated the severity of their AF-related symptoms at baseline and at each follow-up visit for the study.
Symptoms that were assessed at each visit included the presence of palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and/or lack of energy upon exertion or exercise.
Each symptom was rated on a scale from 1 (no symptoms) to 5 (most severe).
Total scores were obtained by adding up the rating for each symptom to obtain a range of results between 5 (asymptomatic) to 25 (severely symptomatic).
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6 Months
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The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline
時間枠：6 months
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The SF-36 is a short-form health survey of 36 questions that yields an 8-scale health profile as well as psychometrically-based physical and mental health summary measures.
In order to assess improvement in self-perceived quality of life, subjects were asked to complete SF-36 questionnaires at baseline and at each follow-up visit.
The results of the Physical Component and Mental Component scores from the two summary measures that aggregate sub-scales were then compared.The SF-36 subscales range from 0 (lowest) to 100 (highest).
The subscales are averaged together for a total score between 0 to 100.
A higher score represents a better outcome when compared to a lower score.
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6 months
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Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins
時間枠：After Procedure
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Cumulative RF time was calculated by the difference between the start time of catheter ablations and the end time of the ablation
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After Procedure
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Total Procedure Time
時間枠：End of Procedure
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Measurement of total procedure time defined as "skin to skin" and left atrial dwell time (transseptal puncture to removal of all left atrial catheters)
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End of Procedure
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Total Fluoroscopy Time
時間枠：Post Ablation Procedure
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Total time that flouroscopy was used during the ablation procedure.
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Post Ablation Procedure
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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。
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10月1日
一次修了 (実際)
2009年9月1日
研究の完了 (実際)
2011年7月1日
試験登録日
最初に提出
2008年8月28日
QC基準を満たした最初の提出物
2008年8月29日
最初の投稿 (見積もり)
2008年9月1日
学習記録の更新
投稿された最後の更新 (実際)
2018年9月19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。
RF Ablation procedureの臨床試験
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Montefiore Medical CenterAlbert Einstein College of Medicine終了しました
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Pier LambiaseUniversity Hospital Southampton NHS Foundation Trust; The Royal Bournemouth Hospital完了
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GiMer Medical完了
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Syneron Medical完了