NCT06645249Not yet recruitingPhase 4
Evaluation of Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation
Multicenter, Randomized Clinical Trial to Evaluate the Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 2 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Phase: IV Population: Sample size= 122 patients; male and female; ≥ 18 y.o.; patients with persistent atrial fibrillation referred for electrical cardioversion; performed in Spain Number of Sites: 4 Study Duration: 15/10/2024 - 15/5/2026 Subject Participation Duration: 2-4 months (depending on the arm) Description of Agent or Intervention: amiodarone Objectives: Primary: To compare the efficacy of amiodarone in pre-ECV reversal to sinus rhythm in a one-month impregnation regimen versus a 5-day regimen Secondary: 1) Identify days from initiation of pre-ECV amiodarone to reversion to SR using a mobile device paired to the mobile phone; 2) To compare the joint efficacy in the reversion to SR pre-ECV and in the maintenance of SR at 1 month after ECV of a one-month pre-ECV amiodarone impregnation regimen vs a 5-day regimen Description of Study Design: Multicenter randomized open clinical trial. 122 Patients with persistent AF (≥7 days duration) electively referred for CVE will be included. Two amiodarone regimens administered pre-CVE will be compared evaluating their cardioverter efficacy. Patients will be randomized to 2 groups: 1. Treatment impregnation with amiodarone starting one month before ECV (600 mg/day 1st week, 400 mg/day 2nd week and 200 mg/day thereafter until ECV). 2. Treatment impregnation with amiodarone 800 mg/day started 5 days before ECV. Estimated Time to Complete Enrollment: 13 months
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- First submitted
- 30 Sept 2024
- Start date
- 10 Dec 2024
- Primary completion date
- Sept 2026
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Diseases
- Atrial fibrillation
- NCT number
- NCT06645249
- EU CT number
- 2023-507201-34-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 122
- From 10 Dec 2024 to the primary completion date, Sept 2026
- 3 sites 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
- Treatment with anti-arrhythmic drugs (IC, III) the last 7 days previous to inclusion (in the case of amiodarone on the 30 days previous to inclusion)
- Participation in another clinical trial involving investigational drugs
Other illness
- Mean Heart rate \<50 bpm
- Atrial fibrillation post-cardiac surgery
- New York Heart Association (NYHA) Class IV heart failure
- History of thyroid disease (hyperthyroidism or hypothyroidism)
- Allergy, intolerance, or known hypersensitivity to study medication
Lab values
- Left ventricular ejection fraction (LVEF) ≤30%
- Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST \> 3 x upper limit of normal (ULN)
Other
- Need of urgent electrical cardioversion
- Planned ablation \< 1 month after ECV.
- Women of childbearing potential unwilling to use contraceptive measures
- Life expectancy less than 12 months
- Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction.
Who the study is looking for
- Patients ≥18 years old.
- Persistent atrial fibrillation (≥ 7 days duration).
- Referred for elective electrical cardioversion.
- Signing of the informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.