POL-CA Registry: Multicenter Observational Study of Neuromodulatory Procedures in Cardiovascular Autonomic Dysfunction Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Number of Participants with Recurrence of Pre-Treatment Autonomic Symptoms at 12 Months
研究概览
简要总结
The multicentre observational study POL-CA involves a wide spectrum of patients with a history of syncopy. The study recruits patients with diagnosed vasovagal syndrome, cardioinhibitory carotid sinus syndrome, symptomatic sinus bradycardia or atrioventricular block, postural orthostatic tachycardia syndrome, orthostatic hypotension, and inappropriate sinus tachycardia syndrome. This is an observational, controlled study with retrospective, clinical data analysis of previously treated patients and the analysis of syncopal patients prospectively recruited into the study. The aim of the POL-CA registry is to create a platform for physicians to record treatment data for patients undergoing procedures that affect innervation or modify cardiovascular reflexes (cardioneuroablation, cardioneuromodulation) in order to provide a multicentre summary of population characteristics and treatment outcomes based on a standardized POL-CA questionnaire and methodology for various arrhythmias.
详细描述
The study aims to include a group of at least 1,000 individuals, taking into account subgroups of patients with rare diseases involving fewer than 50 individuals (e.g., carotid sinus hypersensitivity or familial sinus bradycardia). Participants will be divided into three age groups: 18-40 years, 41-60 years, and over 60 years. These individuals will undergo procedures affecting innervation or modifying cardiovascular reflexes (cardioneuroablation or neuromodulation) due to ineffective pharmacological treatment or training methods. This group will also include patients who, according to guidelines, qualify for pacemaker implantation but declined the procedure.
The clinical trial protocol specifies inclusion and exclusion criteria. The protocol outlines the collection of various data, including traditional medical history (including contact information) and data related to the interventional treatment performed (including assessment of treatment efficacy and the occurrence of both perioperative and long-term complications). Additionally, the protocol includes the use of scales and questionnaires to evaluate patient symptoms and well-being, as well as an analysis of standard and non-standard verbal and non-verbal behaviors of patients. Scales and questionnaires used to assess patient symptoms and well-being: EQ-5D, SF-36, VASIS for bradycardia symptoms (daytime, before sleep, nighttime, and morning), and MALMO scoring test.
Patients will also routinely undergo physical performance evaluations (assessment using the Borg scale, HRR analysis, correlation of heart rate values during exercise before and after the procedure, 6MWT walk tests, and analysis of tele-rehabilitation outcomes).
Patient follow-up will be conducted at 1, 6, and 12 months post-procedure and then annually from 2024 to 2030, with ECG evaluations. The primary endpoint of the study is the spontaneous recurrence of symptoms that were present before the procedure affecting innervation and/or cardiovascular reflexes.
Enrolment in the POL-CA registry does not involve performing any additional invasive medical procedures on the patients.
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
- •Age ≥ 18 years
- •Diagnosis of at least one of the following conditions:
- •Inappropriate sinus tachycardia (IST)
- •Postural orthostatic tachycardia syndrome (POTS)
- •Vasovagal syncope (VVS)
- •Cardioinhibitory carotid sinus syndrome (CSS)
- •Symptomatic sinus bradycardia or functional AV block
- •Orthostatic hypotension (OH)
- •History of recurrent autonomic symptoms (e.g., syncope, bradycardia, palpitations, orthostatic intolerance)
- •Undergoing or previously underwent interventional treatment affecting cardiac autonomic innervation (e.g., cardioneuroablation, SN-sparing ablation, cardiac sympathetic denervation)
- •Provided written informed consent (for prospective arm)
排除标准
- •Structural heart disease requiring surgical intervention
- •Permanent pacemaker or ICD implanted prior to enrollment
- •Inability to complete follow-up assessments or questionnaires
- •Severe psychiatric comorbidities impairing participation
- •Participation in another interventional clinical trial
结局指标
主要结局
Number of Participants with Recurrence of Pre-Treatment Autonomic Symptoms at 12 Months
时间窗: Baseline and 1, 6, and 12 months post-intervention
Recurrence is defined as the spontaneous return of autonomic symptoms (e.g., syncope, orthostatic intolerance, palpitations, bradycardia) that were present before the intervention. Symptoms are confirmed by clinical assessment, structured questionnaires (e.g., VASIS, MALMO, EQ-5D), and ECG data. This outcome will help evaluate the long-term effectiveness of autonomic modulation procedures.
次要结局
未报告次要终点