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

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

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.

Study Overview

• Status: Unknown
• Conditions: Persistent Atrial Fibrillation; Catheter Ablation
• Intervention / Treatment: Diagnostic test: LA pressure, voltage map, strain, scar-map, blood sampling; Procedure: pulmonary vein isolation

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1122
    • Recruiting
    • Heart and Vascular Center of Semmelweis University
    • Contact: Peter Perge, MD; Phone Number: 0036208259612; Email: perge.peter@med.semmelweis-univ.hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Diagnostic test: 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; Procedure: pulmonary vein isolation; pulmonary vein isolation without creating additional ablation lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
one-year success of 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	3-12 months after the first pulmonary vein isolation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Semmelweis University Heart and Vascular Center
• Investigators: Principal Investigator: Laszlo Geller, MD PhD, Heart and Vascular Center of Semmelweis University; Study Director: Bela Merkely, MD PhD DSc, Heart and Vascular Center of Semmelweis University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: August 3, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): August 8, 2017
• Last Update Submitted That Met QC Criteria: August 3, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: biomarker; scar; catheter ablation; strain; left atrial function; pulmonary vein isolation; persistent atrial fibrillation; left atrial pressure; success; voltage map
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: LAMPP 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No