Clinical trial NCT06452823: Efficacy and Safety of Catheter Ablation of Atrial Fibrillation in Patients With Thyroid Hormone Stabilization
Official title: Cardiovascular Medicine Department of Second Affiliated Hospital of Jiaxing University
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Atrial Fibrillation and Flutter
Hyperthyroidism
Hypothyroidism
Keywords: Atrial Fibrillation and Flutter
Hyperthyroidism
Hypothyroidism
catheter radiofrequency ablation
Lead sponsor: The Second Affiliated Hospital of Jiaxing University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation Class I Recommendation Without Concurrent Contraindication

Brief summary: Patients with hyperthyroidism or hypothyroidism are often combined with atrial fibrillation, but after the stabilization of thyroid hormone levels after treatment, the patients' atrial fibrillation still persists. Radiofrequency ablation of the atrial fibrillation as one of the treatment options for atrial fibrillation has been widely used in the clinic, and has significant efficacy in maintaining sinus rhythm, improving cardiac function, and improving the prognosis of patients. However, there is a lack of clinical monitoring data on radiofrequency ablation of atrial fibrillation in patients who have combined thyroid dysfunction and have stabilized their thyroid hormone levels after treatment.

Detailed description: In patients recommended by guidelines for atrial catheter radiofrequency ablation of atrial fibrillation, catheter radiofrequency ablation was performed after exclusion of contraindications, and was observed and compared between patients with comorbid pre-existing thyroid hormone disorders and patients without comorbid atrial fibrillation after radiofrequency ablation:1: time to sexual rhythm maintenance: incidence of cardiac-related complications and incidence of noncardiac-related complications within 3 months and 1 year,2: walking distance on a six-minute walk test within 3 months,1 year, comparison of percent left ventricular ejection fraction, and comparison of left ventricular diastolic diameter at the time 3 months,1 year,.To comprehensively assess the efficacy and safety of catheterized radiofrequency ablation of atrial fibrillation in patients with comorbidities of prior thyroid hormone disorders.

Eligibility criteria: Inclusion Criteria:

Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation （Class I Recommendation）

Exclusion Criteria:

Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation Class I Recommendation With Coexisting Contraindications

Primary outcomes:
measure: Recurrence of atrial fibrillation Recurrence of atrial fibrillation Recurrence of atrial fibrillation Recurrence of atrial fibrillation Recurrence of atrial fibrillation Recurrence of atrial fibrillation Recurrence of atrial fibrillation
timeFrame: 3 month and 1year after cardiac radiofrequency ablation
measure: Postoperative heart-related complications
timeFrame: 3 month and 1year after cardiac radiofrequency ablation
measure: Non-Cardiac Related Complications
timeFrame: 3 month and 1year after cardiac radiofrequency ablation
Secondary outcomes:
measure: 6-minute walk test
timeFrame: 3 month and 1year after cardiac radiofrequency ablation
measure: Left Atrial Internal Diameter
timeFrame: 3 month and 1year after cardiac radiofrequency ablation
measure: LVEF%
timeFrame: 3 month and 1year after cardiac radiofrequency ablation
Other outcomes:
measure: Thyroid hormone levels
timeFrame: 3 month and 1year after cardiac radiofrequency ablation
Locations:
city: Jiaxing
country: China
facility: Cardiovascular Medicine Department of Second Affiliated Hospital of Jiaxing University
state: Zhejiang
Study officials:
References: