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

NCT06452823 | Enrolling By Invitation DMC

• 1 other identifier: CMDSAHJiaxing
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation and Flutter; Hyperthyroidism; Hypothyroidism

Keywords

Atrial Fibrillation and Flutter; Hyperthyroidism; Hypothyroidism; catheter radiofrequency ablation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• 6-minute walk test

  3 month and 1year after cardiac radiofrequency ablation

• Left Atrial Internal Diameter

  3 month and 1year after cardiac radiofrequency ablation

• LVEF%

  3 month and 1year after cardiac radiofrequency ablation

Other Outcomes (1)

• Thyroid hormone levels

  3 month and 1year after cardiac radiofrequency ablation

Study Arms (2)

Combined Thyroid Dysfunction

Atrial catheter radiofrequency ablation for atrial fibrillation combined with patients requiring prior thyroid hormone abnormalities

Procedure: Catheter Ablation

Uncomplicated thyroid dysfunction

Atrial catheter radiofrequency ablation for atrial fibrillation in patients with uncomplicated need for prior thyroid hormone abnormalities

Procedure: Catheter Ablation

Interventions

Catheter Ablation PROCEDURE

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.

Combined Thyroid Dysfunction; Uncomplicated thyroid dysfunction

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation Class I Recommendation Without Concurrent Contraindication

You may qualify if:

• Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation （Class I Recommendation）

You may not qualify if:

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

Sponsors & Collaborators

• The Second Affiliated Hospital of Jiaxing University: lead

Study Sites (1)

Cardiovascular Medicine Department of Second Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, 314000, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Hyperthyroidism; Hypothyroidism

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)