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

NCT ID: NCT03242694

Last Updated: 2017-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-12-31

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.

Conditions

Persistent Atrial Fibrillation; Catheter Ablation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

persistent atrial fibrillation

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

LA pressure, voltage map, strain, scar-map, blood sampling

Intervention Type: DIAGNOSTIC_TEST

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

pulmonary vein isolation

Intervention Type: PROCEDURE

pulmonary vein isolation without creating additional ablation lesions

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

pulmonary vein isolation

pulmonary vein isolation without creating additional ablation lesions

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Semmelweis University Heart and Vascular Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laszlo Geller, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Heart and Vascular Center of Semmelweis University

Bela Merkely, MD PhD DSc

Role: STUDY_DIRECTOR

Heart and Vascular Center of Semmelweis University

Locations

Heart and Vascular Center of Semmelweis University

Budapest, , Hungary

Site Status: RECRUITING

Countries

Hungary

Central Contacts

Szilvia Herczeg, MD

Role: CONTACT

herczeg.szilvia@med.semmelweis-univ.hu

0036206663198

Nandor Szegedi, MD

Role: CONTACT

szegedi.nandor@med.semmelweis-univ.hu

0036206663442

Facility Contacts

Peter Perge, MD

Role: primary

perge.peter@med.semmelweis-univ.hu

0036208259612

Other Identifiers

LAMPP 1.0

Identifier Type: -

Identifier Source: org_study_id