Efficacy and Safety of Catheter Ablation of Atrial Fibrillation in Patients With Thyroid Hormone Stabilization

Hypothyroidism Clinical Trial

— SQUIRREL  

Official title:

Cardiovascular Medicine Department of Second Affiliated Hospital of Jiaxing University

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06452823
• Other study ID #: CMDSAHJiaxing
• Status: Enrolling by invitation
• Start date: May 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: The Second Affiliated Hospital of Jiaxing University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation and Flutter
• Atrial Flutter
• Hyperthyroidism
• Hypothyroidism

Intervention

Procedure:
• Catheter Ablation
catheter radiofrequency ablation therapy for atrial fibrillation involves the use of ablative energy to destroy the cardiomyocytes at the opening of the pulmonary veins, which blocks the electrical conduction pathway between the pulmonary veins and the left atrium, so that atrial fibrillation no longer occurs.

Locations

Country	Name	City	State
China	Cardiovascular Medicine Department of Second Affiliated Hospital of Jiaxing University	Jiaxing	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Jiaxing University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Thyroid hormone levels	hyperthyroidism Hypothyroidism A change in thyroid hormone status from stable to unstable.	3 month and 1year after cardiac radiofrequency ablation
Primary	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	Inability to maintain sinus rhythm, recurrent atrial fibrillation or atrial flutter	3 month and 1year after cardiac radiofrequency ablation
Primary	Postoperative heart-related complications	Cardiac perforation/cardiac tamponade Coronary artery stenosis/occlusion Pericarditis Atrial stiffness syndrome Coronary artery air embolism Pseudoaneurysm Severe pulmonary stenosis	3 month and 1year after cardiac radiofrequency ablation
Primary	Non-Cardiac Related Complications	Neurological Complications Asymptomatic cerebral embolism TIA Perioperative stroke Permanent phrenic nerve injury Digestive Complications Esophageal Injury Gastric Hyperdynamics Atrioesophageal Fistula Vascular Complications Hematoma Arteriovenous fistula Pseudoaneurysm Severe pulmonary stenosis	3 month and 1year after cardiac radiofrequency ablation
Secondary	6-minute walk test	Left atrial diastolic diameter	3 month and 1year after cardiac radiofrequency ablation
Secondary	Left Atrial Internal Diameter	Left atrial anteroposterior and superior-inferior diameters	3 month and 1year after cardiac radiofrequency ablation
Secondary	LVEF%	Per-beat output as a percentage of ventricular end-diastolic volume (cardiac preload)	3 month and 1year after cardiac radiofrequency ablation