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Atrial mechanics as predictors of atrial fibrillation’s recurrence after pulmonary vein isolation

Atrial mechanics as predictors of atrial fibrillation’s recurrence after pulmonary vein isolation - EchoAM-AF

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00010495
Enrollment
150
Registered
2016-05-10
Start date
2016-04-24
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I48.0 I48.1

Interventions

Group 1: On every patient with paroxysmal and/or persistent atrial fibrillation, undergoing pulmonary vein isolation, transthoracic and transoesophageal echocardiography will be done. Left and right a

Sponsors

Univeristy Hospital Centre Sisters of Charity
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Men and women, 18-85 years of age with paroxysmal and persistent atrial fibrillation who will undergo pulmonary vein isolation and who are able to understand and sign an informed consent will be included in the study. Paroxysmal atrial fibrillation is defined as atrial fibrillation with self-terminating episodes lasting up to a maximum of 7 days, while persistent atrial fibrillation is defined as atrial fibrillation lasting more than 7 days and/or that required the use of cardioversion (either with antiarrhytmic drugs or electrocardioversion)in ending the episode. Both definitions are taken from the international guidelines of the European Society for Arrhythmias (EHRA) which is part of the European Society of Cardiology (ESC).

Exclusion criteria

Exclusion criteria: 1. Patients on whom the pulmonary vein isolation was already done (re-do PVIs) 2. Patients with 12 months (long lasting atrial fibrillation) or permanent atrial fibrillation 4. Patients with contraindication for using anticoagulant therapy 5. Patients with intracavitary clot which is contraindication for pulmonary vein isolation 6. Patients on whom cavotricuspid isthmus ablation was done 7. Patients on whom echocardiography was not done or it was of low quality 8. Patients who are not in sinus rhythm at the time of performing echocardiography 9. Patients with implanted permanent pacemaker or cardioverter-defibrilator or CRT 10. Patients who underwent cardiothoracic surgery (myocardial revascularisation and/or valvular reparation or replacement) 11. Patients with congenital heart disease (surgically corrected or not) 12. Patients with one or more moderate or heavy valvular disease 13. Pregnant women 14. Patients with hyperthyreosis 15. Chronic obstructive pulmonary disease (COPD) 16. Patients with a history of pulmonary embolism 17. Patients with expected life expectancy < 12 months 18. Patients with anaemia (haemoglobin <100 g/L) 19. Patients with history of alcohol or drug abuse 20. Patients included in other clinical study 21. Patients with the present state of emergency during hospitalization and not caused by heart disease

Design outcomes

Primary

MeasureTime frame
Atrial fibrillation recurrence. Follow-up period of at least 12 months. Outpatient visits will be done 3,6 and 12 months after the PVI was done. On every check-up 24h-72h Holter-EKG will be reviewed as well as clinical symptoms of palpitations or other signs of Afib recurrence.

Secondary

MeasureTime frame
left and right atrial parameters assessed by TTE (Transthoracic echocardiography) and TEE (trransoesophageal echocardiography) left and right appendage parameters assessed by TTE and TEE vena cava superior parameters assessed by TTE and TEE

Countries

Croatia

Contacts

Public ContactIvan Zeljkovic

University Hospital Centre Sisters of Charity

ivanzeljkov@gmail.com+385 1 3787 733

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 17, 2026