Clinical trial NCT03242694: Left Atrial Function Analysis for Patients With Persistent Atrial Fibrillation Undergoing Pulmonary Vein Isolation
Official title: Left Atrial Function Analysis With Multimodal Techniques for Patients With Persistent Atrial Fibrillation Undergoing Pulmonary Vein Isolation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Persistent Atrial Fibrillation
Catheter Ablation
Keywords: persistent atrial fibrillation
pulmonary vein isolation
catheter ablation
left atrial function
left atrial pressure
voltage map
strain
scar
success
biomarker
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with persistent atrial fibrillation referred for pulmonary vein isolation at Heart and Vascular Center of Semmelweis University, Budapest, Hungary.

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.


Eligibility criteria: 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

Primary outcomes:
measure: one-year success of pulmonary vein isolation
timeFrame: 3-12 months after the first pulmonary vein isolation
Secondary outcomes:
measure: acute unsuccessful pulmonary vein isolation
timeFrame: within 5 minutes after the last application is performed at the ablation procedure
measure: usage of antiarrhythmic drugs after the three-month blanking period
timeFrame: 3-12 months after the first pulmonary vein isolation
measure: reablation
timeFrame: 3-12 months after the first pulmonary vein isolation
measure: major complications of pulmonary vein isolation
timeFrame: through 1 year follow-up after the first pulmonary vein isolation
measure: MACE
timeFrame: through 1 year follow-up after the first pulmonary vein isolation
measure: death
timeFrame: through 1 year follow-up after the first pulmonary vein isolation
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Heart and Vascular Center of Semmelweis University
Study officials:
affiliation: Heart and Vascular Center of Semmelweis University
name: Laszlo Geller, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart and Vascular Center of Semmelweis University
name: Bela Merkely, MD PhD DSc
role: STUDY_DIRECTOR
References: