Atrial Fibrillation and FlutterSQUIRRELNCT06452823
Efficacy and Safety of Catheter Ablation of Atrial Fibrillation in Patients With Thyroid Hormone Stabilization
An observational study of Atrial Fibrillation and Flutter and Hyperthyroidism, run by The Second Affiliated Hospital of Jiaxing University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Atrial Fibrillation and Flutter, Hyperthyroidism, Hypothyroidism
- What is being tested?
- Catheter Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation Class I Recommendation Without Concurrent Contraindication
Who may be able to join
- Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation （Class I Recommendation）
Who cannot join
- Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation Class I Recommendation With Coexisting Contraindications
Trial locations and contacts
1 site in 1 country.
China1 site
Cardiovascular Medicine Department of Second Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang, 314000
About this study
Official title: Cardiovascular Medicine Department of Second Affiliated Hospital of Jiaxing University
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.
Read the 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.
- Being tested
- Catheter Ablation
- Keywords
- Atrial Fibrillation and Flutter, Hyperthyroidism, Hypothyroidism, catheter radiofrequency ablation
- Medical subject headings
- Atrial Fibrillation, Hyperthyroidism, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter AblationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined Thyroid Dysfunction | Atrial catheter radiofrequency ablation for atrial fibrillation combined with patients requiring prior thyroid hormone abnormalities Receives: Procedure: Catheter Ablation | |
| Uncomplicated thyroid dysfunction | Atrial catheter radiofrequency ablation for atrial fibrillation in patients with uncomplicated need for prior thyroid hormone abnormalities Receives: Procedure: Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 month and 1year after cardiac radiofrequency ablation
Secondary outcomes (3)
6-minute walk test
Left atrial diastolic diameter
Measured: 3 month and 1year after cardiac radiofrequency ablation
Left Atrial Internal Diameter
Left atrial anteroposterior and superior-inferior diameters
Measured: 3 month and 1year after cardiac radiofrequency ablation
LVEF%
Per-beat output as a percentage of ventricular end-diastolic volume (cardiac preload)
Measured: 3 month and 1year after cardiac radiofrequency ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 May 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation and FlutterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Jiaxing University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452823
- Sponsor's protocol ID
- CMDSAHJiaxing
- Acronym
- SQUIRREL
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no Plan to Share IPD
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Medicine Department of Second Affiliated Hospital of Jiaxing University
- ClinicalTrials.gov ID
- NCT06452823
- Acronym / sponsor ID
- SQUIRREL / CMDSAHJiaxing
- Keywords
- Atrial Fibrillation and Flutter, Hyperthyroidism, Hypothyroidism, catheter radiofrequency ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Jiaxing UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Thyroid Dysfunction | – | Procedure: Catheter AblationAtrial catheter radiofrequency ablation for atrial fibrillation combined with patients requiring prior thyroid hormone abnormalities |
| Uncomplicated thyroid dysfunction | – | Procedure: Catheter AblationAtrial catheter radiofrequency ablation for atrial fibrillation in patients with uncomplicated need for prior thyroid hormone abnormalities |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation Class I Recommendation Without Concurrent Contraindication
Key inclusion criteria (1 listed)
- Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation （Class I Recommendation）
Key exclusion criteria (1 listed)
- Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation Class I Recommendation With Coexisting Contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter Ablationcatheter 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. | Procedure or surgery | Combined Thyroid Dysfunction, Uncomplicated thyroid dysfunction |
Primary outcome
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
Time frame: 3 month and 1year after cardiac radiofrequency ablation
Inability to maintain sinus rhythm, recurrent atrial fibrillation or atrial flutter
Postoperative heart-related complications
Time frame: 3 month and 1year after cardiac radiofrequency ablation
Cardiac perforation/cardiac tamponade Coronary artery stenosis/occlusion Pericarditis Atrial stiffness syndrome Coronary artery air embolism Pseudoaneurysm Severe pulmonary stenosis
Non-Cardiac Related Complications
Time frame: 3 month and 1year after cardiac radiofrequency ablation
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 secondary outcomes
6-minute walk test
Time frame: 3 month and 1year after cardiac radiofrequency ablation
Left Atrial Internal Diameter
Time frame: 3 month and 1year after cardiac radiofrequency ablation
LVEF%
Time frame: 3 month and 1year after cardiac radiofrequency ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No. no Plan to Share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Flutter and Hyperthyroidism, run by The Second Affiliated Hospital of Jiaxing University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 3 month and 1year after cardiac radiofrequency ablation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.