An observational study in Atrial Fibrillation and Flutter, Hyperthyroidism and Hypothyroidism, sponsored by The Second Affiliated Hospital of Jiaxing University. Enrolling by invitation at 1 site in China. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by The Second Affiliated Hospital of Jiaxing University · Observational
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.
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 200 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →This is the only study on the registry with The Second Affiliated Hospital of Jiaxing University as lead sponsor.
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Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation Class I Recommendation Without Concurrent Contraindication
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Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation （Class I Recommendation）
Exclusion Criteria:
Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation Class I Recommendation With Coexisting
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Atrial catheter radiofrequency ablation for atrial fibrillation combined with patients requiring prior thyroid hormone abnormalities
Procedure: Catheter Ablation
Atrial catheter radiofrequency ablation for atrial fibrillation in patients with uncomplicated need for prior thyroid hormone abnormalities
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.
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
Time frame: 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
Time frame: 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
Time frame: 3 month and 1year after cardiac radiofrequency ablation
6-minute walk test
Left atrial diastolic diameter
Time frame: 3 month and 1year after cardiac radiofrequency ablation
Left Atrial Internal Diameter
Left atrial anteroposterior and superior-inferior diameters
Time frame: 3 month and 1year after cardiac radiofrequency ablation
LVEF%
Per-beat output as a percentage of ventricular end-diastolic volume (cardiac preload)
Time frame: 3 month and 1year after cardiac radiofrequency ablation
Thyroid hormone levels
hyperthyroidism Hypothyroidism A change in thyroid hormone status from stable to unstable.
Time frame: 3 month and 1year after cardiac radiofrequency ablation
Plan to share: No — no Plan to Share IPD
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Started May 2024 (actual). Primary completion is estimated for Jun 2026, 25 months after the start.
Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's planned 25 months is below that.
Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.
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