Left Atrial Function Analysis for Patients With Persistent Atrial Fibrillation Undergoing Pulmonary Vein Isolation

• Conditions: Persistent Atrial Fibrillation; Catheter Ablation
• Interventions: Diagnostic Test: LA pressure, voltage map, strain, scar-map, blood sampling; Procedure: pulmonary vein isolation

• Registration Number: NCT03242694
• Lead Sponsor: Semmelweis University Heart and Vascular Center

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 - described as left atrial (LA) function - are simultaneously studied by multi-modal techniques in patients undergoing radiofrequency ablation. The simultaneous measurements are conducted before the PVI in AF and after the sinus rhythm converted due to PVI. These measurements include invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples. During the one year follow-up period rhythm monitoring is conducted by regular Holter-monitoring. Our aim is to define the predictive values of the above mentioned factors and to create a new score system for predicting PVI success in persistent AF population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-31
• Status Verified: 2017-08
• Study Start: 2017-08-01
• Study First Submitted QC: 2017-08-03
• Last Update Submitted: 2017-08-03
• Study First Posted: 2017-08-08
• Last Update Posted: 2017-08-08
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
persistent atrial fibrillation	LA pressure, voltage map, strain, scar-map, blood sampling	invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples during atrial fibrillation and after pulmonary vein isolation in sinus rhythm
persistent atrial fibrillation	pulmonary vein isolation	invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples during atrial fibrillation and after pulmonary vein isolation in sinus rhythm

Primary Outcome Measures

Name	Time	Method
one-year success of pulmonary vein isolation	3-12 months after the first pulmonary vein isolation	one-year success without recurrent atrial fibrillation or atrial tachycardia without antiarrhythmic drugs after the three-month blanking period of pulmonary vein isolation

Secondary Outcome Measures

Name	Time	Method
reablation	3-12 months after the first pulmonary vein isolation	repeated left atrial ablation is performed due to atrial fibrillation or left atrial tachycardia recurrence
acute unsuccessful pulmonary vein isolation	within 5 minutes after the last application is performed at the ablation procedure	operator is unable to disconnect pulmonary veins from the left atrium
major complications of pulmonary vein isolation	through 1 year follow-up after the first pulmonary vein isolation	major complications: requiring surgical intervention or causing prolonged hospitalisation
MACE	through 1 year follow-up after the first pulmonary vein isolation	major adverse cardiac events
death	through 1 year follow-up after the first pulmonary vein isolation
usage of antiarrhythmic drugs after the three-month blanking period	3-12 months after the first pulmonary vein isolation	antiarrhythmic drugs: sotalol, amiodarone, propafenon

Trial Locations

Locations (1)

Heart and Vascular Center of Semmelweis University; 🇭🇺 Budapest, Hungary