Hospital Clinic, University of Barcelona
Barcelona, 08036, Spain
Location status: Recruiting
Location contact
Ivo Roca-Luque, M.D., Ph.D.
CONTACT
Lluis Mont, M.D., Ph.D.
CONTACT
NCT Number: NCT07358611
The goal of this pilot study is to test if noninvasive global mapping can guide catheter ablation defining personalized targets and improve the therapy of atrial fibrillation. It will also test the safety of such an approach. The main questions it aims to answer are:
* Does ablation of targets defined by noninvasive global mapping improve rates of acute atrial fibrillation termination? * Does such a personalized ablation approach reduce arrhythmia recurrence rates? Researchers will compare the results of the personalized ablation approach with comparable patients that had undergone a conventional "empirical" ablation approach (pulmonary vein isolation).
Participants will:
* Undergo a personalized catheter ablation approach employing both a noninvasive global mapping system and a conventional intracardiac mapping system * Visit the clinic 3, 6 and 12 months after ablation for clinical follow-up * Schedule a telephone visit 9 and 24 months after ablation for clinical follow-up
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Barcelona, 08036, Spain
Location status: Recruiting
Ivo Roca-Luque, M.D., Ph.D.
CONTACT
Lluis Mont, M.D., Ph.D.
CONTACT
The aim of this study is to test the feasibility and potential of a personalized, non-invasive mapping-guided ablation approach in patients with persistent atrial fibrillation (AF), who are unlikely to benefit from empirical pulmonary vein isolation alone. As a pilot study, it is designed to assess feasibility and procedural efficacy and potential signals of harm.
General Strategy:
Patients with persistent AF planned for catheter ablation are eligible in case of left atrial enlargement.
The study intervention consists of
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Ablation-naïve patients with:
Exclusion criteria
The study intervention consists of
Time frame: Procedural
Rate of acute AF termination (ro sinus rhythm or conversion into an organized atrial tachycardia) upon ablation
Time frame: Days 91 to 365 post-ablation
Absence of any atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between days 91 and 365 post ablation. AF, AFL or AT will qualify as a recurrence after ablation if it lasts 30 s or longer.
Time frame: Days 91 to 365 post-ablation
Absence of atrial fibrillation [AF] between days 91 and 365 post ablation. AF will qualify as a recurrence after ablation if it lasts 30 s or longer
Time frame: Day 0 to 30 post-ablation
Composite safety endpoint composed of:
Contact information is provided by the study sponsor or research team.
Ivo Roca-Luque, M.D., Ph.D.
CONTACT
Till F Althoff, M.D.
CONTACT
Hospital Clinic of Barcelona
Other
ELectrocardiographic Imaging-guided Substrate Ablation in Patients With Atrial Fibrillation - a PILOT Study of a Personalized Therapy
Acronym: ELISA-AF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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