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Radiofrequency Ablation for Amiodarone-induced Thyrotoxicosis

Not Applicable
Terminated
Conditions
Amiodarone-Induced Thyrotoxicosis
Interventions
Device: RFA
Registration Number
NCT03720210
Lead Sponsor
Mayo Clinic
Brief Summary

Investigators intend to study the changes in thyroid hormone storage and production in amiodarone-induced thyrotoxicosis patients after RFA therapy.

Detailed Description

Investigators plan to identify patients with amiodarone-induced thyrotoxicosis (AIT) that failed to respond to medical therapy or have developed side effects from medical therapy or are considered high risk for such therapy.

These patients will be offered the option to undergo radiofrequency ablation (RFA) of a portion of the thyroid gland in order to decrease thyroid hormone production and/or to inactive the existing thyroid hormone store before their leakage into the circulation.

Investigators will follow these patients to assess their clinical response as well as their thyroid values. The safety of the procedure will also be assessed.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
1
Inclusion Criteria
  • Are adults
  • Have overt thyrotoxicosis (within 2 weeks prior to enrollment)
  • Are receiving medical therapy for AIT
  • Are able to understand the study procedures and to comply with them for the entire length of the study
  • Have not normalized their thyroid levels after one month of standard therapy or
  • Have persistent and clinically significant thyrotoxicosis (less than 25% decrease in T4 value or patients requiring hospitalization with Congestive heart failure (CHF), tachyarrhythmias, hemodynamic instability or similar co-morbidities) after 2 weeks of standard therapy where additional medical therapy is deemed unlikely to be beneficial or with high risk of side-effects (e.g. hepatotoxicity of antithyroid medications, agranulocytosis of potassium perchlorate or ATD or fluid retention associated with steroids).
Exclusion Criteria
  • Pregnancy
  • Patients with prior neck surgery or neck radiation
  • Patients with neck anatomy that precludes easy access by RFA to the entirety of thyroid parenchyma
  • Patients on anticoagulation therapy
  • Patients with comorbidities deemed too high of a risk for general anesthesia
  • Treatment with another investigational drug or intervention (within 6 weeks of planned RFA).
  • Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
RFA groupRFARFA
Primary Outcome Measures
NameTimeMethod
Free T4 Response Post RFA3 - 6 months

Thyroid tests

Total T3 Response Post RFA3 - 6 months

Thyroid tests

Secondary Outcome Measures
NameTimeMethod
Pain Related to RFA Procedure1 - 2 months

McGill Pain Questionnaire

Thyroid-stimulating Hormone (TSH) Response Post RFA3 - 6 months

Thyroid tests

Trial Locations

Locations (1)

Mayo Clinic in Rochester

🇺🇸

Rochester, Minnesota, United States

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