Dipole Intracardiac Mapping With ACUTUS System for Catheter Ablation of Atrial Fibrillation in Hypertrophic Cardiomyopathy
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Clinical efficacy to achieve SR defined as time (in minutes) to termination of AF into stable SR
研究概览
简要总结
BACKGROUND About 1/4 of patients with hypertrophic cardiomyopathy (HCM) seem to develop atrial fibrillation (AF) over their life-span. Typically, symptoms of heart failure and especially shortness of breath get much worse once AF is present. Catheter ablation of AF in HCM has been proposed by several centres, but outcomes are much worse than in non-HCM AF. Accurate mapping of the arrhythmia is crucial with regard to improving the procedural outcome. Interestingly, intracardiac mapping during AF has demonstrated very long average cycle length during ongoing AF in HCM which should make identification of the critical re-entry/rotors much easier using dipole cardiac mapping (Acutus mapping system, Acutus Medical, CA, USA).
POPULATION and PURPOSE This is a pilot trial recruiting a total of 20 patients with HCM and AF (paroxysmal or persistent with <12 months duration time in persistent AF) eligible for catheter ablation, without other significant structural heart disease Primary endpoints
Safety:
- Absence of acute adverse events due to the use of ACUTUS mapping system during AF ablation
- Evidence of chronic adverse events due to the use of ACUTUS mapping system guided catheter ablation during the 12 months F/U period
- Safety endpoint of the entire mapping and ablation strategy
Efficacy:
- Assessment on efficacy of ACUTUS mapping system guided AF ablation in HCM patients using a double-arm study design
- RF time to termination of AF to SR Secondary endpoints
- RF time to termination of AF to atrial tachycardia (AT)
- Freedom from AF/flutter/tachycardia (> 30 sec) at the end of the 12 months follow up (F/U) period
- Time to first recurrence of AF/flutter/tachycardia (> 30 sec)
- Freedom of AF/flutter/tachycardia on previously failed anti-arrhythmic medication Ablation procedure First 10 patients (group 1): ablation will be carried out after acquisition of a left atrium (LA) and right atrium (RA) dipole map at baseline, pre and post administration of Adenosine IV. Then pulmonary vein isolation (PVI) as a first step and subsequent remap and ablation of all patterns of interest in the LA until restoration of sinus rhythm (SR) or decision to proceed with direct current cardioversion (DCCV, 360J).
Second 10 patients (group 2): after the acquisition of a dipole map of LA and RA at baseline (pre and post Adenosine IV administration), ablation of all identified areas of interest (API) will be performed, followed by remap and finally PVI +/- DCCV.
For all patients: final step will be the deployment of a RA isthmus line and demonstration of bidirectional block.
FOLLOW UP Patients will be followed up at 3, 6, and 12 months.
详细描述
FOLLOW UP
Patients will be followed up at 3, 6, and 12months with:
- clinical visit, symptoms questionnaire, electrocardiogram (ECG), ECG Holter (3, 6, and 12 months);
- trans-thoracic echocardiogram (only at 12months);
- Three-dimensional late gadolinium enhancement cardiac magnetic resonamce - 3D LGE- CMR (if possible, only at 6 months); exercise cardiopulmonary test (only pre-ablation and at 6 months).
SAFETY REPORTING RECORDING ADVERSE EVENTS (AES) All Adverse Events will be recorded in the hospital notes and Case Report Form (CRF).
If the Investigator suspects that the disease has progressed faster due to the administration of the study treatment/procedure, then he/she will report this as an unexpected adverse event to the Sponsor and the REC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal or persistent AF (time in persistent AF < 12 months duration) including re-ablations
- •Able to give written informed consent
- •Age >18 years old and ≤ 80 years
- •Fulfil established clinical criteria for diagnosis of HCM and catheter ablation of atrial fibrillation
- •Normal LV ejection fraction and no evidence of other significant structural heart disease
排除标准
- •Reversible causes of AF/flutter/tachycardia
- •Recent cardiovascular event including TIA
- •Intolerance or unwillingness to oral anticoagulation with Warfarin or NOAC
- •Bleeding disorder
- •Contraindication to CT or CMR scan
- •Presence of intra-cardiac thrombus
- •Vascular disorder preventing access to femoral veins
- •Cardiac congenital abnormality different from HCM
- •Severe, life threatening non cardiac disease
- •Active malignant disease and recent (<5 years) malignant disease
- •Presence of ASD or PFO closure device
- •Previous ASD or PFO surgical closure
- •Unable or unwilling to comply with F/U requirements
研究组 & 干预措施
Group1 - PVI first step
Catheter ablation procedure:
Dipole map of RA and LA at baseline (5 times for both, each for 20sec, +/- Adenosine IV)
- PVI as first step
- Remap to assess any change in activation
- Ablate all rotors (API) in LA until SR or DCCV
- Deployment of RA CTI line and demonstration of bidirectional block
干预措施: Catheter ablation procedure (Procedure)
Group2 - PVI last step
Catheter ablation procedure:
Dipole map of RA and LA at baseline (5 times for both, each for 20sec, +/- Adenosine IV)
- Ablate all rotors (API) in LA until SR or DCCV
- Remap to assess any change in activation
- PVI as last step even when SR achieved earlier
- Deployment of RA CTI line and demonstration of bidirectional block
干预措施: Catheter ablation procedure (Procedure)
结局指标
主要结局
Clinical efficacy to achieve SR defined as time (in minutes) to termination of AF into stable SR
时间窗: 12 months
• Assessment on efficacy of ACUTUS mapping system guided AF ablation in HCM patients using a double-arm study design. Time to termination of AF to SR
Acute procedural safety assessed by incidence (number and type) of acute procedure-related Adverse Events
时间窗: 12 months
• Absence of acute adverse events due to the use of ACUTUS mapping system during AF ablation
Chronic procedural safety assessed by incidence (number and type) of chronic procedure-related Adverse Events
时间窗: 12 months
• Evidence of chronic adverse events due to the use of ACUTUS mapping system guided catheter ablation during the 12 months F/U period
Overall safety of the entire mapping and ablation strategy defined by incidence (number and type) of acute and chronic Adverse Events, differentiated into those related to the mapping system (ACUTUS) and those related to the ablation procedure
时间窗: 12 months
• Safety endpoint of the entire mapping and ablation strategy
次要结局
- clinical long term outcome(12 months)
- Clinical outcome including drugs(12 months)
- Overall RF time delivered till SR(12 months)
- Time to first recurrence(12 months)