Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular Tachycardia (UNITE-VT)
Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular Tachycardia: a UK Randomised Controlled Trial
Ventricular tachycardia (VT) is an abnormal and dangerous heart rhythm affecting the lower chambers of the heart (the ventricles). Patients with structural heart disease caused by previous heart attacks are at an increased risk of developing VT. Current guidelines recommend that patients who develop this abnormal heart rhythm are considered for invasive catheter ablation (ICA). This is an invasive procedure where specialised catheters and a 3D electro anatomical mapping (EAM) system are used to identify the region of the heart responsible for the VT, which is then treated by tissue heating or freezing (ablation). Although significant improvements have been made in both mapping and ablation technologies, these procedures remain technically challenging and time consuming.
View into ventricular onset (VIVO, Catheter Precision) is a non-invasive, mapping system already being used within the NHS. It uses images from previous heart scans, a picture of the patient's chest (taken at the start of the procedure) and a 12-lead electrocardiogram (ECG) tracing, to locate where the VT is coming from. The VIVO map can therefore highlight the likely region of interest for ICA prior to invasive EAM.
This study will be a prospective, multi-centre, two-arm, non-blinded, randomised controlled trial (RCT). Patients will be evenly randomised (50:50) into a standard VT ablation group and a VIVO guided ablation group. In the VIVO guided ablation group, invasive EAM will be restricted to the region of interest identified using the VIVO map, rather than whole chamber mapping required for standard ablation. The primary objective will be to determine if the VIVO non-invasive mapping system reduces procedure duration and therefore improves workflow efficiency. Secondary objectives will assess the procedural success, safety and patient perceived health benefits of a VIVO guided ablation versus standard ablation.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Brighton、イギリス、BN2 1ES
- まだ募集していません
- Royal Sussex County Hospital
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コンタクト：
- John Silberbauer, Dr.
- 電話番号：01273 664943
- メール：john.silberbauer@nhs.net
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Coventry、イギリス、CV2 2DX
- 募集
- University Hospitals Coventry and Warwickshire
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コンタクト：
- Tarv Dhanjal, Dr.
- 電話番号：02476 966400
- メール：Tarv.Dhanjal@uhcw.nhs.uk
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コンタクト：
- Jaffar Al-Sheikhli, Dr.
- 電話番号：024 7696 2415
- メール：Jaffar.Al-Sheikhli@uhcw.nhs.uk
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Middlesbrough、イギリス、TS4 3B
- 募集
- The James Cook University Hospital
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コンタクト：
- Matthew Bates, Dr.
- 電話番号：58229 01642 858229
- メール：matthew.bates1@nhs.net
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コンタクト：
- Simon James, Dr.
- メール：simon.james1@nhs.net
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- ≥18 years old
Patient with the following:
- Evidence of post-myocardial infarction* structural heart disease.
- Cardiac CT and/or cardiac MRI scan performed within 6 months.
- ICD/CRTD implantation.
- Device therapy for VT: at least 1 appropriate ICD shock or 3 ATP episodes within a 6-month period.
- Suitable candidate for VT ablation as per NHS standard of care.
- Patient agrees to comply with study procedures and be available for routine follow up visits for at least 6 months after enrolment.
Exclusion Criteria:
- Lacks capacity to provide informed consent.
- Presence of intramural thrombus, tumour or abnormality that precludes vascular access, catheter introduction or manipulations.
- Coagulopathy, bleeding diathesis or suspected pro-coagulant state.
- Sepsis, active systemic infection or fever (>100.5 F/38 C) within a week prior to the ablation procedure.
- Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the patient or deem the patient inappropriate to participate in the study.
- Known allergies or intolerance to AADs to be used to treat PVCs.
- Known allergy for contrast.
- Female patients who are pregnant or breast feeding.
- Enrolment in a concurrent interventional clinical study that in the judgement of the investigator would increase risk to the patient or deem them inappropriate to participate in this study.
- Other conditions that may prevent patients from adhering to the study protocol, in the opinion of the investigator.
研究計画
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：支持療法
- 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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アクティブコンパレータ：VIVO-assisted VT ablation
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VIVO (or View Into Ventricular Onset) is a non-invasive cardiac mapping technology which uses images from patients' previous heart scans, a picture of their chest (taken at the start of the procedure) and a tracing of their VT, to locate where the ventricular tachycardia is coming from.
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介入なし：Standard VT Ablation
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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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Total procedural time (minutes)
時間枠：day of procedure
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the time from first incision (needle to skin) to the removal of the venous/arterial sheaths
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day of procedure
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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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Procedure time in VT (minutes)
時間枠：during VT ablation procedure
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during VT ablation procedure
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Mapping time (minutes)
時間枠：during VT ablation procedure
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during VT ablation procedure
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Ablation time (minutes).
時間枠：During VT ablation procedure
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During VT ablation procedure
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Total number of ablation applications
時間枠：During ablation procedure
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During ablation procedure
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Total number of shocks delivered
時間枠：during the VT ablation procedure
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during the VT ablation procedure
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Number of Participants with VT non-inducibility determined by Programmed Ventricular Stimulation (PVS)
時間枠：during VT ablation procedure
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during VT ablation procedure
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Number of Participants with substrate modification confirmed by remap
時間枠：during the VT ablation procedure
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during the VT ablation procedure
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Total number of ICD/CRTD determined appropriate shock events
時間枠：day of procedure to 6 months post-procedure
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Total number of ICD/CRTD shock events per patient will be documented on database
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day of procedure to 6 months post-procedure
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Total number of ICD/CRTD determined anti-tachycardia pacing (ATP) events
時間枠：day of procedure to 6 months post-procedure
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Total number of ICD/CRTD ATP events per patient will be documented on database
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day of procedure to 6 months post-procedure
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Total number of VT episodes as determined from ICD/CRTD
時間枠：day of procedure to 6 months post-procedure
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day of procedure to 6 months post-procedure
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Recognised VT ablation procedural complications
時間枠：day of the procedure to 30 days after the VT ablation procedure
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day of the procedure to 30 days after the VT ablation procedure
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Total number of hospitalisations
時間枠：day of the procedure to 30 days after the VT ablation procedure
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Total number of hospitalisation events per patient will be documented on database
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day of the procedure to 30 days after the VT ablation procedure
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Mortality
時間枠：day of the procedure to 30 days after the VT ablation procedure
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day of the procedure to 30 days after the VT ablation procedure
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Perceived health benefit of treatment
時間枠：at baseline and 6 months
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EQ-5D-5L
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at baseline and 6 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- TD660525
- SOC.12/24-25 (その他の識別子：University of Warwick)
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?
IPD プランの説明
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
米国FDA規制機器製品の研究
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