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

Persistent Atrial Fibrillation Clinical Trial

— LAMPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03242694
• Other study ID #: LAMPP 1.0
• Status: Recruiting
• Phase: N/A
• First received: July 31, 2017
• Last updated: August 3, 2017
• Start date: August 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2017
• Source: Semmelweis University Heart and Vascular Center
• Contact: Szilvia Herczeg, MD
• Phone: 0036206663198
• Email: herczeg.szilvia[@]med.semmelweis-univ.hu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Catheter Ablation
• Persistent Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Hungary	Heart and Vascular Center of Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	usage of antiarrhythmic drugs after the three-month blanking period	antiarrhythmic drugs: sotalol, amiodarone, propafenon	3-12 months after the first pulmonary vein isolation
Secondary	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
Secondary	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
Secondary	MACE	major adverse cardiac events	through 1 year follow-up after the first pulmonary vein isolation
Secondary	death		through 1 year follow-up after the first pulmonary vein isolation