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ECG-I Phenotyping of Persistent AF Based on Driver Distribution to Predict Response to Pulmonary Vein Isolation (PHENOTYPE-AF)

2018年7月10日 更新者:Barts & The London NHS Trust

Atrial fibrillation (AF) is an irregular heart rhythm associated with significant morbidity and mortality. The pulmonary veins (the blood vessels carrying blood from the lungs into the left atrium) have been shown to send electrical signals into the heart that can cause and maintain AF. Pulmonary vein Isolation (PVI) is an established treatment where catheters are passed into the atria of the heart to deliver lines of scar to electrically isolate the pulmonary veins preventing them from transmitting these electrical signals into the left atrium.

The ECG-I is a system which involves wearing a jacket with many ECG electrodes to record electrical activity from the surface of the body. A CT scan then shows where these electrodes are relative to the atria, and computer modelling is used to reconstruct the movements of electricity on the surface of the heart and therefore identifying where the drivers (tissue causing and maintaining AF) are located.

Unfortunately, not all patients respond to PVI due to the drivers of AF being located in areas other than within the Pulmonary Veins. Identifying the drivers of AF is very difficult and the role they play has yet to be proved scientifically.

The investigators intend to enroll 100 patients with persistent AF and perform atrial mapping using the ECG-I system. Solely pulmonary vein isolation will be performed. Patients will be followed up to see if the distribution of drivers as predicted by the ECG-I predicts outcomes. This may improve patient selection for this procedure.

調査の概要

状態

わからない

条件

詳細な説明

Atrial Fibrillation (AF) is the commonest heart rhythm disturbance and is associated with significant morbidity and mortality. Catheter ablation (CA) is a procedure where catheters (leads) are passed into the heart and energy is used to disrupt and isolate (by freezing or cauterising) heart tissue causing AF. CA is an established therapy for AF. Success rates for CA for paroxysmal AF lies in the region of 70% or better. However, success rates for persistent AF is much lower and estimates lie in the region of 30-60%.

Current CA protocols for AF centre on isolating the pulmonary veins (the pulmonary veins drain into the left atrium) which have been proven to trigger AF. Pulmonary Vein Isolation (PVI) ablation alone seems sufficient to remove the trigger for the vast majority of patients with paroxysmal AF. However, in patients with persistent AF it is common for AF to continue after the pulmonary veins have been electrically isolated.

The difference in success rates between the paroxysmal and persistent form of AF is thought to be due to changes within the heart atria after AF has been established for some time. In persistent AF the atria dilate and remodel structurally and electrically, and therefore the maintenance of persistent AF differs from paroxysmal AF.

Persistent AF is thought to be maintained by focal sources, whether rotors or sites of radial activation. Currently, targeting other sites within the atria in addition to PVI such as fractionated electrograms (areas of electrical activity) are thought to be imprecise and require extensive ablation. Often AF will persist despite targeting additional sites within the atria.

One particular challenge is to select patients likely to benefit from CA. CA carries an approximate less than 1% risk of life threatening complication. Therefore being able to select suitable patients is desirable in order to prevent unnecessary procedures.

Currently clinical characteristics of patients or structural imaging have limited accuracy in selecting patients likely to benefit from CA. Mapping studies have shown that patients with persistent AF who have higher frequency signals near the pulmonary veins than being distributed in the left atrial body are more likely to terminate to sinus rhythm (normal heart rhythm) with PVI alone and to maintain sinus rhythm.

Studies have suggested that patients undergoing standard PVI ablation procedures for persistent AF who have coincidental interruption of drivers have a far better long term outcome. This suggests that the characteristics of atrial heart tissue and electrical activation patterns maintaining AF are likely to determine the response to ablation therefore it may be possible to determine more directly and accurately the likelihood of success by performing non-invasive mapping of the atria using the ECG-I.

It appears that a proportion of patients with persistent AF will maintain sinus rhythm long term after undergoing AF CA with standard PVI protocols alone. PVI can now be achieved quickly and safely using technologies such as the Cryoballoon (A freezing technology). Identification of patients that are likely to respond to PVI alone is therefore of great interest as it (1) identifies patients that may respond to a conservative strategy, and (2) in the absence of an effective strategy beyond PVI may allow de-selection of patients unlikely to benefit from ablation at all.

研究の種類

介入

入学 (予想される)

100

段階

  • 適用できない

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

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~80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:

  1. Patients diagnosed with Persistent AF (i.e. episodes of AF that are continuous for > 1 week or have required DC cardioversion)
  2. Willing for ablation.
  3. Age between 18 to 80.
  4. left atrial diameter <5 cm
  5. left ventricular function >40%.
  6. New York Heart Association class < 3.

Exclusion Criteria:

  • Persistent AF diagnosed > 2 years ago
  • left atrial diameter > 5 cm
  • Severe left ventricular impairment (EF < 40%)
  • New York Heart Association class 3 or 4 heart failure
  • Known hypertrophic cardiomyopathy, cardiac sarcoid, or arrythmogenic ventricular cardiomyopathy.
  • Known inherited arrhythmia such as Brugada or long QT syndromes
  • Valvular disease that is more than moderate
  • History of valve replacement (metallic or tissue)
  • History of congenital heart disease (other than patent foramen ovale)
  • Previous left atrial ablation (percutaneous or surgical)
  • Cardiac surgery or percutaneous coronary intervention within the last 3 months.
  • Myocardial infarction or unstable angina within the last 3 months.
  • Unwillingness for ablation
  • Unwillingness to be involved in study
  • Suspected reversible cause of AF
  • Any other contraindication to catheter ablation
  • Age < 18 yrs or > 80 years
  • Pregnancy
  • Morbid obesity (defined as BMI >40)
  • Any other medical problem likely to cause death within the next 18 months

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
実験的:ECG-I mapping and PVI
ECG-I mapping and PVI

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
Freedom from Atrial Arrhythmia and association with distribution of drivers of AF
時間枠:Performed 12-14 months post procedure
All patients will undergo mapping with ECG-I during their procedure. The number of drivers and their locations will be collected. Patients who remain free from AF at 12 months will be compared to patients who relapsed comparing the number and location of these drivers.
Performed 12-14 months post procedure

二次結果の測定

結果測定
メジャーの説明
時間枠
Impact of pulmonary vein isolation on drivers of AF
時間枠:During AF Catheter Ablation
Patients will undergo ECG-I mapping of their AF at baseline and then immediately after pulmonary vein isolation. The number of drivers and locations will be collected at both points and these will be compared to assess the impact of PVI.
During AF Catheter Ablation

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。

捜査官

  • 主任研究者:Ross Hunter、Barts Heart Centre

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。

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 (実際)

2018年1月8日

一次修了 (予想される)

2019年12月1日

研究の完了 (予想される)

2020年12月1日

試験登録日

最初に提出

2017年12月4日

QC基準を満たした最初の提出物

2018年1月3日

最初の投稿 (実際)

2018年1月9日

学習記録の更新

投稿された最後の更新 (実際)

2018年7月11日

QC基準を満たした最後の更新が送信されました

2018年7月10日

最終確認日

2017年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 218367-1

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

はい

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。

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