NCT06742866Not yet recruiting
Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation
The Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 19 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to investigate the efficacy and safety of intravenous combined with oral amiodarone in preventing atrial fibrillation (AF) recurrence after catheter ablation in patients with persistent atrial fibrillation. Using a randomized controlled trial design, patients will be divided into two groups: intravenous + oral amiodarone and oral amiodarone alone. Through multiple follow-ups at 1, 3, 6, and 12 months post-procedure, the study will compare the two treatment regimens in terms of blood concentrations of amiodarone and its metabolites, efficacy (short-term recurrence \[SR\], long-term recurrence \[LR\], and patient quality of life), and safety (adverse drug reactions). Subgroup analyses will also be conducted to explore potential differences in drug treatment effects among populations with varying risk factors. This study aims to provide valuable clinical data for post-ablation management of atrial fibrillation, contributing to the development of optimized treatment strategies to enhance therapeutic outcomes and improve patient quality of life.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 418 (estimated)
- First submitted
- 16 Dec 2024
- Start date
- 16 Dec 2024
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Shanghai Chest Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT06742866
What you commit to
- Study type: Interventional
- Planned participants: 418
- From 16 Dec 2024 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those unwilling or unsuitable to restart or continue antiarrhythmic drug therapy;
Other illness
- Allergy to amiodarone components;
- Contraindications to amiodarone (e.g., blood pressure \< 90/60 mmHg; bradycardia \< 55 bpm, second- or third-degree AV block, or sick sinus syndrome);
- Thyroid disorders, such as hyperthyroidism or hypothyroidism.
Other
- Life expectancy \< 12 months;
- Severe liver or kidney dysfunction;
- Pregnant or breastfeeding women;
Who the study is looking for
- Participants aged ≥18 years;
- First-time catheter ablation for persistent atrial fibrillation (defined as any - previous episode lasting ≥7 days);
- Symptomatic atrial fibrillation patients who have failed or are intolerant to at least one class I or III antiarrhythmic drug;
- Participants who are able to understand the purpose of the study, voluntarily agree to participate, and provide written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.