NCT05343923Completed
Atrial Fibrillation Characterization on Paroxysmal and Persistent Patients
Electrophysiological Substrate Characterization of Paroxysmal and Persistent Atrial Fibrillation: PAPER-AF Study
Source: ClinicalTrials.gov · Last updated 15 Mar 2024
Brief summary (registry, in English)
Background and Hypothesis: Atrial Fibrillation (AF) treatment strategies have limitations. The efficacy of the procedure depends in several factors such as age, AF duration, atrial diameter and atrial electrophysiological behavior, determining what has been termed as atrial substrate. Therefore, the effectiveness of one specific treatment such as the ablation procedure, will be determined by the areas responsible for the maintenance of the fibrillation and its modification and/or elimination. The identification of these areas with a clear description of the arrhythmic substrate is one of the most important factors to determine new biomarkers that explain, at electrophysiological level, the properties of the substrate and therefore, increase the acute efficacy and long-term effectiveness of the treatment.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 55 (actual)
- First submitted
- 19 May 2021
- Start date
- 1 Jun 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Felipe Atienza
- Diseases
- Atrial fibrillation
- NCT number
- NCT05343923
What you commit to
- Study type: Observational
- Participants enrolled: 55
- From 1 Jun 2021 to the primary completion date, 31 Dec 2023
- 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
- Patients with inadequate anticoagulation levels, left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on TEE prior to the procedure.
- Current enrollment in another investigational drug or device study.
Other
- Patients with moderate-to-severe mitral regurgitation.
- Patients with contraindications to systemic anticoagulation with heparin or coumadin.
- Patients who are or may potentially be pregnant.
Who the study is looking for
- Patients with paroxysmal or persistent AF symptomatic and refractory to at least one antiarrhythmic medication arriving in sinus rhythm to the electrophysiology laboratory.
- Patients must be able and willing to provide written informed consent to participate in the study.
- Prior anticoagulation for\> 4 weeks or transesophageal echocardiogram excluding intracardiac thrombi.
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 |
|---|---|---|---|
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.