Defining the Risk of Ventricular Tachycardia in Genetic Forms of Early-onset Atrial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- VT Inducibility
研究概览
简要总结
To use programmed ventricular stimulation at the time of AF ablation to define the prevalence and mechanism of inducible ventricular tachycardia (VT); pace-mapping to define the site of origin of ventricular arrhythmias; and voltage mapping to define low voltage scar substrate in the basal LV in patients with pathogenic TTN variants compared to genotype-negative controls.
详细描述
Participants will undergo AF ablation according to standard, contemporary techniques. The procedure will be performed under general anesthesia. As part of routine standard of care in patients with early-onset AF or patients who have PVCs, we will also test for inducibility of VT using a standardized pacing protocol. The research protocol will include LV mapping and identification of low voltage substrate using electroanatomical mapping as described below.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 and older
- •Diagnosed with AF before age 60
- •Scheduled for catheter-based AF ablation (de-novo or repeat)
- •Able to provide written, informed consent
- •P/LP variant in TTN or other CM gene (cases) or identified as a genotype-negative control.
排除标准
- •Diagnosed with a genetic CM or arrhythmia syndrome prior to AF
- •VUS in 'possibly pathogenic' subgroup (control group only)
- •Pacemaker or ICD
- •Previous PVC or VT ablation
- •Prosthetic mitral or aortic valve
- •Contraindication to heparin
- •Prior myocardial infarction.
研究组 & 干预措施
Pathogenic variant in TTN
50 patients with a pathogenic variant in TTN
干预措施: EP Study (Diagnostic Test)
Pathogenic variant in other cardiomyopathy genes
50 patients with a pathogenic variant in other cardiomyopathy genes
干预措施: EP Study (Diagnostic Test)
Genotype-negative controls
100 genotype-negative controls
干预措施: EP Study (Diagnostic Test)
结局指标
主要结局
VT Inducibility
时间窗: At the time of procedure
The primary endpoint is induction of sustained VT that is determined to be reentrant or likely-reentrant. Sustained VT will be defined as VT lasting 30 seconds or requiring termination with burst pacing or cardioversion due to hemodynamic instability.
Presence of ventricular arrhythmias per specific site
时间窗: At the time of procedure
The primary endpoint is the occurrence (yes/no) of ventricular arrhythmias (PVCs, NSVT, sustained VT) that are mapped to the basal LV as defined above.
Low voltage substrate
时间窗: At the time of procedure
The primary endpoint is the presence of low voltage (yes/no) in the basal LV.
次要结局
- Site of origin for ventricular arrhythmias(At the time of procedure)
- Evaluation of electrogram potentials(At the time of procedure)
- Presence of low voltage(At the time of procedure)
研究者
M. Benjamin Shoemaker
Associate Professor of Medicine
Vanderbilt University Medical Center