Status:
UNKNOWN
Left Atrial Function Analysis for Patients With Persistent Atrial Fibrillation Undergoing Pulmonary Vein Isolation
Lead Sponsor:
Semmelweis University Heart and Vascular Center
Conditions:
Persistent Atrial Fibrillation
Catheter Ablation
Eligibility:
All Genders
18-75 years
Brief Summary
This prospective observational study is designed to describe the factors determining the success of pulmonary vein isolation (PVI) for patients with persistent atrial fibrillation (AF). These factors ...
Eligibility Criteria
Inclusion
- documented, symptomatic persistent atrial fibrillation (AF)
- catheter ablation is indicated
- aged 18-75 years
- signed Patient Informed Consent Form
- able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion
- secondary AF
- paroxysmal, long-standing persistent or permanent AF
- ejection fraction \< 30%
- GFR \<30 ml/min/1.73m2
- unstable angina pectoris or myocardial infarction within the past 2 months
- severe heart failure (NYHA IV)
- severe COPD (GOLD III-IV)
- previous left atrial catheter ablation
- previous transthoracic cardiac surgery
- implanted cardiac device (pacemaker, ICD, CRT, VAD)
- awaiting cardiac transplantation or other cardiac surgery within the next 12 months
- any contraindication for pulmonary vein isolation, MRI or anticoagulation
- coagulopathy
- active malignancy, left atrial myxoma
- autoimmune disorder, chronic inflammatory disease
- acute illness, active systemic infection, sepsis
- women who are pregnant, breast feeding, or planning to become pregnant in the next 12 months
- aged under 18 years or above 75 years
- enrollment in other studies, which exclude participation in other studies
- patient not willing or not able to sign the informed consent form
Key Trial Info
Start Date :
August 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03242694
Start Date
August 1 2017
End Date
December 31 2019
Last Update
August 8 2017
Active Locations (1)
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1
Heart and Vascular Center of Semmelweis University
Budapest, Hungary, 1122