NCT04466358Completed
CLOSE Versus High Density Mapping Guided Catheter Ablation of Paroxysmal Atrial Fibrillation
Comparison of CLOSE Guided and High Density Mapping Guided Catheter Ablation of Paroxysmal Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 16 Oct 2024
Brief summary (registry, in English)
The aim of this study is to compare two methods of catheter ablation for treatment of paroxysmal atrial fibrillation (AF). The first method being a modified CLOSE protocol used for the control group and the second high density mapping guided isolation of pulmonary veins used for the interventional group. Comparison will be made according to clinical parameters and also durability of pulmonary vein isolation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 7 Jul 2020
- Start date
- 26 Feb 2021
- Primary completion date
- 1 Sept 2024
- Lead sponsor
- University Medical Centre Ljubljana
- Diseases
- Atrial fibrillation
- NCT number
- NCT04466358
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 26 Feb 2021 to the primary completion date, 1 Sept 2024
- 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
- previous heart surgery,
- previous atrial fibrillation ablation
Other illness
- acute life-threatening disease,
- severe valve failure,
Lab values
- severe left or right ventricular dysfunction (LVEF equal or less than 35 %),
Age
- age over 80 years,
Other
- greatly enlarged left atrium (ultrasound parasternal diameter more than 50 mm),
- life expectancy less than one year,
- presence of a clot in the left atrium,
Who the study is looking for
- electrocardiographic evidence of paroxysmal AF in the last six months,
- unsuccessful treatment with antiarrhythmic drugs or highly symptomatic arrhythmia episodes (EHRA 3 and 4).
Age in the registry: 18 years to 80 years · 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 |
|---|---|---|---|
| UMC Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.