VIVO Non-invasive Time Assessment Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 主要终点
- Reduction of procedural time (in minutes)
研究概览
简要总结
This is a single centre study enrolling 15 subjects with structurally normal hearts that are already indicated for a ventricular ablation procedure (VT or PVCs).
The purpose is to compare the accuracy of VIVO and to assess its efficacy to decrease procedural time, and ideally, the procedural overall costs, as compared to standard of care ablation procedures. Results will be compared with data from
详细描述
VIVO TM is a non invasive mapping system which can be used to localize PVC / VT origin prior to the ablative procedure.
Subjects scheduled for catheter ablation with VIVO will undergo a CT scan prior to the procedure, which will be used to create a personalized 3D model. This will be merged with a 3D photograph (taken at the start of the procedure) of the ECG electrodes on the subject's torso.
Then, the recording of the 12 lead ECG will be imported into the VIVO software. All of this data will be combined via the software and a mathematical algorithm will determine the origin of the arrhythmia. This will show the physician where to perform a successful ablation. After 3 months, the subject will return for follow up and will receive another ECG Holter monitor (ECG recording) to determine ablation success.
Subjects will be exited from the study after the 3 month follow up visit. Patients will receive standard clinical care prior to, during and after their scheduled procedure, as well as after being discarded from the trial.
Results will be analysed and compared to those from an historical cohort of patients (age / gender matched, undergone the same procedure) ablated by the same operator within the previous 5 years (from a database already collected). Data will be anonymised as per current regulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are at least 18 years or older
- •Subjects who are scheduled for PVC/VT ablation procedure
- •Subjects who have signed an IRB/EC approved Informed Consent Form and applicable subject privacy protection authorization per local law
- •Subjects will be selected without regard to gender or age (unless precluded by local regulatory requirements)
- •Subjects with or without cardiac structural disease
排除标准
- •Reversible causes of PVC/VT
- •Subjects with recent (within 3 months) acute coronary syndrome
- •Subjects who are contraindicated for CT or MRI (must be able to get one)
- •Subject whose MRI or CT scan does not comply with the requirements of this protocol
- •Subjects who are contraindicated for an electrophysiology procedure and/or fluoroscopy:
- •INR > 3.5
- •Active infection
- •Pregnancy: Females of childbearing potential with a positive pregnancy test.
- •Existing mechanical heart valve
- •Subjects with structural cardiac disease
研究组 & 干预措施
VIVO mapping pre-procedure
15 patients with structurally normal heart and indication for PVC/VT catheter ablation, who will undergo pre-procedural non invasive mapping with VIVO mapping system.
干预措施: VIVO non invasive mapping (Diagnostic Test)
结局指标
主要结局
Reduction of procedural time (in minutes)
时间窗: three months
Use of VIVO mapping to localize the PVC / VT origin prior to the catheter procedure in order to change procedural time. Procedural time is meant to be measured in minutes per procedure, and it is normally considered from "puncture time" to "sheaths removal".
Safety - absence of acute adverse events using VIVO system for non-invasive mapping
时间窗: three months
Absence of acute adverse events due to the use of VIVO system during PVC/VT ablation in the cohort of patients enrolled for the study. Acute adverse events are described in section 12 of the study protocol and will be reported in specific forms to the Sponsor and REC.
Safety 2 - absence of acute adverse events using VIVO system for mapping and during the whole ablation procedure
时间窗: three months
Safety endpoint of the entire mapping and ablation strategy, determined by the absence of adverse events (AEs).
次要结局
- clinical outcome assessed as change of PVCs/VT burden(three months)
- economical outcome: change of procedural costs(three months)