Investigation of Substrates Associated With the Recurrence of Atrial Fibrillation After PV Cryoablation

NCT03587181 | Completed

• 1 other identifier: 01-04/18
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The two main mechanisms for atrial fibrillation (AF) recurrence after cryoablation include Pulmonary vein (PV) reconnection and the presence of non-PV associated arrhythmic focuses. The aim of this study is to investigate the prevalence of each mechanism and if biomarkers may be used to predict of these events. Eighty patients with paroxysmal or persistent AF will undergo PV isolation with cryoablation followed by loop recorder implantation. Patients in whom atrial tachyarrhythmias recur during 12 months follow-up (outside of the 3-month post procedure blanking window) will be offered a second electrophysiology study (EP) study to assess PV isolation and non-PV focuses and further ablation performed as required. At baseline blood samples will be taken to investigate the correlation between specific biomarkers and both the incidence and type of recurrence. The correlation between recurrence of atrial tachyarrhythmias due to non-PV associated arrhythmic focuses and elevated baseline levels of NT-ProBNP, CRP, TNF, MMP1 will be pre-specified. 40 consecutive patients will have a biopsy taken from the intraventricular and interatrial septum to investigate the correlation between myocardial inflammation, the presence of fibrosis and recurrence of atrial tachyarrhythmias. Correlation between biomarkers of inflammation and biopsy-proven myocardial inflammation or fibrosis will be assessed.

Conditions

Atrial Fibrillation

Keywords

Cryoballoon, Cryoablation, biobanking, Loop recorder, biopsy

Outcome Measures

Primary Outcomes (1)

• Atrial tachyarrhythmia recurrence

  Atrial tachyarrhythmias recurrence by ECG, Holter monitoring or loop recorder after 3 months of blanking period

  1 year

Secondary Outcomes (6)

• The prevalence of PV reconnection and non-PV focuses as substrate of atrial tachyarrhythmia after cryoablation

  1 year

• The difference in baseline NT-ProBNP levels between those patients with recurrence of atrial tachyarrhythmias due to non-PV associated arrhythmic focuses and those without at 12 months

  1 year

• The difference in baseline CRP levels between those patients with recurrence of atrial tachyarrhythmias due to non-PV associated arrhythmic focuses and those without at 12 months

  1 year

• The difference in baseline TNF levels between those patients with recurrence of atrial tachyarrhythmias due to non-PV associated arrhythmic focuses and those without at 12 months

  1 year

• The difference in baseline MMP1 levels between those patients with recurrence of atrial tachyarrhythmias due to non-PV associated arrhythmic focuses and those without at 12 months

  1 year

Interventions

Cryoablation of the pulmonary veins and myocardial biopsy PROCEDURE

Before intervention blood samples will be collected for biobank storage. After left atrial appendage thrombus exclusion, a cardiac biopsy from intraventricular and interatrial septum will be performed. PV isolation will be performed with cryoablation. Successful PV isolation will be confirmed by the confirmation of bi-directional block. Phrenic nerve function will be assessed in a standard fashion during intervention of the right PVs using high output phrenic nerve pacing from the superior vena cava. Loop recorder implantation will be performed during the same procedure. In patients with recurrent atrial tachyarrhythmias an EP study will be performed to assess the mechanism of recurrence. PV reconnections will be re-isolated and linear lesions performed as required.

Also known as: loop recorder implantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18-80 years old with symptomatic paroxismal or persistant atrial fibrillation (EHRA scale 2b-4)

You may qualify if:

• Patient with paroxysmal/persistent atrial fibrillation (EHRA scale 2b-4)

You may not qualify if:

• prior interventions for AF
• permanent AF
• contraindications to oral anticoagulation or heparin
• chronic kidney disease requiring dialysis
• untreated hypo- or hyperthyroidism
• breast feeding
• pregnancy
• chronic kidney disease requiring dialysis
• decompensated heart failure
• stroke within the last 3 months
• myocardial infarction within the last 3 months
• Percutaneous coronary intervention or Coronary Artery Bypass Grafting within the last 3 months
• active myocarditis
• artificial valve replacement surgery
• severe mitral or aortic stenosis

Sponsors & Collaborators

• National Research Center for Preventive Medicine: lead
• I.M. Sechenov First Moscow State Medical University: collaborator

Study Sites (1)

National Research Center for Preventive Medicine

Moscow, 101990, Russia

Location

Related Publications (1)

• Davtyan K, Topchyan A, Brutyan H, Kalemberg E, Simonyan G, Serdyuk S, Kharlap M, Bazaeva E. Does cryoballoon ablation affect the symptom severity of atrial fibrillation? Insights from 12-months continuous cardiac monitoring. BMC Cardiovasc Disord. 2025 Sep 26;25(1):674. doi: 10.1186/s12872-025-05134-4.

  PMID: 41013270 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Before intervention blood samples will be collected for biobank storage. It is planned to assess levels of NT-proBNP, high-sensitive CRP, TNF, IL1B, FABP, MMP1, MMP3, MMP9, TGF-beta1, TIMP-1, FGF-9.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 16, 2018
• Study Start: April 3, 2017
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)