Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias Symptomatic Using Novel CARTO Technologies: REAL Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 75
- 主要终点
- Effectiveness at 90 days
研究概览
简要总结
The primary purpose of this Registry is to assess procedural safety and long-term effectiveness of catheter ablations in the treatment of subjects with PAF, PsAF, and VA. The Registry will utilize real world clinical data obtained from the use of commercially available CARTO™ technologies under the authority of a health care practitioner within a legitimate practitioner-subject relationship. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term effectiveness of catheter ablation with novel technologies for arrhythmia patients.
详细描述
The REAL Registry is an observational, prospective, multi-center, non-randomized registry designed to obtain real-world clinical experience of ablation using Biosense Webster, Inc. (BWI) CARTO technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF, QDOT MICRO™, VARIPULSE™). Future new Biosense Webster, Inc. technologies, including new thermal and/or pulsed field ablation (PFA), may be included as they become commercially available.
Current clinical practice guidelines recommend ablation for ventricular arrhythmias (VA) and atrial fibrillation (AF)1,2. Therefore, REAL AF will include subjects with symptomatic paroxysmal AF (PAF), persistent AF (PsAF) who meet all eligibility criteria and in the opinion of the investigator, are candidates for AF catheter ablation. CORE-VA will include all subjects with documented ventricular arrhythmia appropriate for catheter ablation.
All subjects will be treated with commercially approved BWI ablation catheters, and the ablation procedure will be conducted based on the participating Site's current standard of care (SOC). Participation in the Registry does not influence treatment decisions. All consecutive subjects presenting at the Site considered for an ablation procedure should be screened by the Investigator or a designated member of the research team for eligibility.
The objective of this registry is to assess clinical outcomes, including procedural efficiency, safety, long-term, effectiveness of RF ablations in the treatment of patients with Paroxysmal or Persistent atrial fibrillation. The outcomes of the registry are: 1) long term effectiveness defined as freedom from Arrhythmia recurrence post 90-day blanking period, 2) acute safety defined by serious complications within 7 days post ablation and up to 30 days post ablation.
Sites and Investigators considered for inclusion in the Registry will be assessed to determine if their practice patterns align, minimally, with what is outlined in VISIT SCHEDULE AND DATA COLLECTION of this protocol for the specific cohort in which the investigators will be enrolling. Investigators need to only align with the requirements of one cohort, but can participate in both, if qualified, and selected in each cohort. The Registry does not require any additional visits above what is considered standard of care follow-up for the Registry subject population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •REAL AF Cohort
- •Inclusion Criteria:
- •Symptomatic PAF (AF episode terminate spontaneously within 7 days) or PsAF (AF sustained beyond 7 days, but less than 365 days) subjects who, in the opinion of the investigator, are candidates for catheter ablation.
- •>18 years of age.
- •Will be treated with Biosense Webster Inc. ablation technologies
- •All AF ablations performed with BWI catheters are included. This includes repeat ablations where the index procedure was performed with a non-BWI catheter.
- •Able and willing to participate in baseline and follow up evaluations
- •Willing and able to provide informed consent, if applicable.
排除标准
- •Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
- •Long-standing persistent AF (AF greater than one year)
- •In the opinion of the investigator, any known contraindication to an ablation procedure
- •CORE VA Cohort
- •Inclusion Criteria:
- •Documented ventricular arrhythmia appropriate for catheter ablation.
- •>18 years of age.
- •Will be treated with Biosense Webster Inc. ablation technologies
- •Able and willing to participate in baseline and follow up evaluations
- •Willing and able to provide informed consent, if applicable.
- •Exclusion Criteria:
- •Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan.
- •In the opinion of the investigator, any known contraindication to an ablation procedure.
研究组 & 干预措施
REAL AF
Subjects with symptomatic PAF or PsAF who, in the opinion of the investigator, are candidates for ablation for AF, age 18 years or older, and are able and willing to comply with all pre-, post-, and follow-up testing and requirements.
干预措施: Catheter ablation (Device)
CORE VA
Subjects with documented ventricular arrhythmia appropriate for catheter ablation, greater than 18 years of age, will be treated with Biosense Webster Inc. ablation technologies, and are willing and able to participate in baseline and follow up evaluations.
干预措施: Catheter ablation (Device)
结局指标
主要结局
Effectiveness at 90 days
时间窗: 90 days
Freedom from arrhythmia recurrence at 90 days post procedure.
Effectiveness at 12 months
时间窗: 12 months
Freedom from subject reported arrhythmia recurrence through 12 months post procedure.
Long-term Safety
时间窗: 30 days post ablation
Incidence of late onset complications, 30 days post-ablation which are procedure and/or device related
次要结局
- Post-procedure arrhythmia treatments(12 months)
- Arrhythmia recurrence(12 months)
- Arrhythmia related symptoms(12 months)
- AAD Usage(12 months)
- OAC usage(12 months)
- Patient reported outcome(12 months)
- CHA2DS2VASC(12 months)