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

NCT03242694 | Unknown

• 1 other identifier: LAMPP 1.0
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

persistent atrial fibrillation; pulmonary vein isolation; catheter ablation; left atrial function; left atrial pressure; voltage map; strain; scar; success; biomarker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• acute unsuccessful pulmonary vein isolation

  within 5 minutes after the last application is performed at the ablation procedure

• usage of antiarrhythmic drugs after the three-month blanking period

  3-12 months after the first pulmonary vein isolation

• reablation

  3-12 months after the first pulmonary vein isolation

• major complications of pulmonary vein isolation

  through 1 year follow-up after the first pulmonary vein isolation

• MACE

  through 1 year follow-up after the first pulmonary vein isolation

Study Arms (1)

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; Procedure: pulmonary vein isolation

Interventions

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

persistent atrial fibrillation

pulmonary vein isolation PROCEDURE

pulmonary vein isolation without creating additional ablation lesions

persistent atrial fibrillation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University Heart and Vascular Center: lead

Study Sites (1)

Heart and Vascular Center of Semmelweis University

Budapest, 1122, Hungary

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood samples

MeSH Terms

Conditions

Atrial Fibrillation; Sprains and Strains; Cicatrix

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Fibrosis

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laszlo Geller, MD PhD

  Heart and Vascular Center of Semmelweis University

  PRINCIPAL INVESTIGATOR

• Bela Merkely, MD PhD DSc

  Heart and Vascular Center of Semmelweis University

  STUDY DIRECTOR

Central Study Contacts

Szilvia Herczeg, MD

CONTACT

0036206663198; herczeg.szilvia@med.semmelweis-univ.hu

Nandor Szegedi, MD

CONTACT

0036206663442; szegedi.nandor@med.semmelweis-univ.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 8, 2017
• Study Start: August 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 8, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)