NCT06832033 Concurrent Training in Patients Undergoing Atrial Fibrillation Ablation.
| NCT ID | NCT06832033 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Marcos Echevarría |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-09-09 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-09-09 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Atrial fibrillation (AF) is an irregular and often very fast heart rhythm, is considered the most common sustained cardiac arrhythmia in adults worldwide, and its incidence and prevalence are increasing. Currently, the estimated prevalence of AF in adults is 2-4%, and is projected to increase 2.3-fold. AF is associated with increased morbimortality and other comorbidities (hypertension diabetes etc.) which places a significant burden on the patient himself, social health and also on health and social care expenditure. The European Society of Cardiology proposes an integrated ABC model (A: Anticoagulation, B: main symptom management, C: optimization of comorbidities and cardiovascular) and within this model, catheter ablation (B) is considered one of the main treatments to control AF symptoms; physical activity (C) is considered one of the modifiable health risk factors and is considered within a lifestyle intervention together with weight loss. Catheter ablation of AF is currently the treatment of choice for paroxysmal AF. It uses small burns or frostbite to cause some scarring inside the heart to help interrupt the electrical signals that cause the irregular heartbeat. It is a safe procedure that has been shown to be more effective than treatment with antiarrhythmic drugs in reducing the arrhythmic burden and, therefore, the morbidity and mortality associated with the pathology. Many studies have demonstrated the beneficial effects of moderate physical activity and physical exercise on cardiovascular health. However, there is still controversy as to whether physical activity is associated with an increased risk of AF in the general population; while some studies report a decreased risk of AF, others suggest an increase or that there is no evidence of an association between AF and physical activity. Few studies have yet focused on the effects of physical activity in those subjects who have undergone catheter ablation. Studies that have evaluated physical activity with questionnaires associate it, when of moderate or high intensity, with lower recurrence of AF and lower incidence of serious events. It is true that the practice of regular and controlled physical exercise is a recognized part of the comprehensive care of patients with coronary heart disease (patients whose heart has difficulty receiving blood), and exercise is systematically identified as a central element of their rehabilitation. However, to date there is no similar approach for AF ablation patients. Given the current situation of the subject of interest, the main objective of this project is to study the influence of a physical exercise program in patients undergoing catheter ablation of AF on different morphological and physiological variables of the heart, levels of physical activity and quality of life of patients. Investigators intend to recruit 120 participants, who will be randomly and equally distributed into a group that will perform a physical exercise intervention and a control group that will not perform any type of intervention. Participation in the study will not disrupt the normal practice of the health care system with these patients.
Eligibility Criteria
Inclusion Criteria: * Patients aged ≥18 years * Undergoing catheter ablation as medical treatment for AF at least one year prior to enrollment. Exclusion Criteria: * Patients who do not sign the informed consent for participation in the study. * Severe atrial dilatation. * Structural heart disease. * Pathology that prevents the normal practice of intervention with physical exercise
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06832033 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06832033 currently recruiting?
Yes, NCT06832033 is actively recruiting participants. Contact the research team at mechevarria@unizar.es for enrollment information.
Where is the NCT06832033 trial being conducted?
This trial is being conducted at Zaragoza, Spain.
Who is sponsoring the NCT06832033 clinical trial?
NCT06832033 is sponsored by Marcos Echevarría. The trial plans to enroll 120 participants.
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