Early Recurrences of Atrial Arrhythmias and Their Impact on Late Recurrence After Pulmonary Vein Isolation With Pulsed Field Ablation of Paroxysmal Atrial Fibrillation

NCT05328882 | Unknown FDA Device

• 1 other identifier: 2181-147/01/06/M.S.-21-02
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-arm study conducted in University Hospital of Split, Department of Cardiology. Patients treated with PFA for symptomatic paroxysmal atrial fibrillation will be asked to participate in the study. An implantable loop recorder (ILR) will be placed immediately after the PFA procedure for rhythm monitoring. Early recurrences will be subsequently divided into very early recurrences (up to 1 month post-procedure) and early recurrences (1-3 months post-procedure). Late recurrences will be defined as those 3 to 12 months post-procedure. Patients will be monitored routinely through follow up visits during which ILR will be interrogated and eventual symptoms will be assessed. Follow-up visits will be scheduled 1, 3, 6, 12 months post-procedure. Median follow-up will be 12 months. Data for the study will be obtained from a loop monitor to assess the arrhythmia burden during follow-up visits in the University Hospital of Split Arrhythmia Clinic.

Conditions

Atrial Fibrillation Paroxysmal; Recurrence

Keywords

Pulsed field ablation

Outcome Measures

Primary Outcomes (1)

• Number of participants with AF recurrence 3-12 months post-procedure

  Number of participants with AF recurrence 3-12 months post-procedure (AF burden defined by loop recorder findings)

  12 months

Secondary Outcomes (2)

• Adverse event rate

  12 months

• Number of patients with very early AF recurrence (within 1 month post procedure)

  12 months

Study Arms (2)

ERAF after PFA

Patients with an early recurrence after pulsed field ablation of paroxysmal atrial fibrillation.

Other: Monitoring of paroxysmal atrial fibrillation recurrence after pulsed field catheter ablation

no ERAF after PFA

Patients without an early recurrence after pulsed field ablation of paroxysmal atrial fibrillation.

Other: Monitoring of paroxysmal atrial fibrillation recurrence after pulsed field catheter ablation

Interventions

Monitoring of paroxysmal atrial fibrillation recurrence after pulsed field catheter ablation OTHER

The implanted loop recorder will be interrogated to see how many patients had an early recurrence of AF (up to 3 months after the procedure). Then the late recurrence rate will be compared (3-12 months post-procedure) between groups with and without early recurrences.

ERAF after PFA; no ERAF after PFA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic paroxysmal atrial fibrillation after at least one failed or intolerant group I or III of antiarrhythmic drug that are eligible for PFA and are willing and able to provide informed consent.

You may qualify if:

• Age \>18
• Index PFA procedure after one failed or intolerant group I or III of the antiarrhythmic drug in patients with symptomatic paroxysmal AF (AF with self-terminating episodes lasting no longer than 7 continuous days)
• Willing and able to provide informed consent.

You may not qualify if:

• Any known contraindication to AF ablation or anticoagulation.
• History of previous left atrial ablation or surgical treatment.
• Secondary AF due to reversible or non-cardiac cause such as thyroid disease and electrolyte imbalance.
• Asymptomatic AF patients, persistent AF, permanent AF patients.
• History of clotting or bleeding disease or cryoglobulinemia.
• Pregnant or lactating.
• Other conditions that may make the patient a poor candidate for procedure such as mental illness, terminal illness, vulnerable patient population.

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Study Sites (1)

University Hospital Center Split

Split, Split-Dalmatia County, 21000, Croatia

RECRUITING

Related Publications (14)

• Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

  PMID: 32860505 BACKGROUND

• Tanno K, Kobayashi Y, Kurano K, Kikushima S, Yazawa T, Baba T, Inoue S, Mukai H, Katagiri T. Histopathology of canine hearts subjected to catheter ablation using radiofrequency energy. Jpn Circ J. 1994 Feb;58(2):123-35. doi: 10.1253/jcj.58.123.

  PMID: 8196154 BACKGROUND

• Grubman E, Pavri BB, Lyle S, Reynolds C, Denofrio D, Kocovic DZ. Histopathologic effects of radiofrequency catheter ablation in previously infarcted human myocardium. J Cardiovasc Electrophysiol. 1999 Mar;10(3):336-42. doi: 10.1111/j.1540-8167.1999.tb00680.x.

  PMID: 10210495 BACKGROUND

• Malmborg H, Christersson C, Lonnerholm S, Blomstrom-Lundqvist C. Comparison of effects on coagulation and inflammatory markers using a duty-cycled bipolar and unipolar radiofrequency pulmonary vein ablation catheter vs. a cryoballoon catheter for pulmonary vein isolation. Europace. 2013 Jun;15(6):798-804. doi: 10.1093/europace/eus411. Epub 2013 Jan 29.

  PMID: 23362019 BACKGROUND

• Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Cosedis Nielsen J, Curtis AB, Davies DW, Day JD, d'Avila A, Natasja de Groot NMS, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T; Document Reviewers:. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Europace. 2018 Jan 1;20(1):e1-e160. doi: 10.1093/europace/eux274. No abstract available.

  PMID: 29016840 BACKGROUND

• Willems S, Khairy P, Andrade JG, Hoffmann BA, Levesque S, Verma A, Weerasooriya R, Novak P, Arentz T, Deisenhofer I, Rostock T, Steven D, Rivard L, Guerra PG, Dyrda K, Mondesert B, Dubuc M, Thibault B, Talajic M, Roy D, Nattel S, Macle L; ADVICE Trial Investigators*. Redefining the Blanking Period After Catheter Ablation for Paroxysmal Atrial Fibrillation: Insights From the ADVICE (Adenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination) Trial. Circ Arrhythm Electrophysiol. 2016 Aug;9(8):e003909. doi: 10.1161/CIRCEP.115.003909.

  PMID: 27516462 BACKGROUND

• Mariani MA, Pozzoli A, Maat G, Alfieri OR, Benussi S. What Does The Blanking Period Blank? J Atr Fibrillation. 2015 Dec 31;8(4):1268. doi: 10.4022/jafib.1268. eCollection 2015 Dec.

  PMID: 27957225 BACKGROUND

• Reddy VY, Anic A, Koruth J, Petru J, Funasako M, Minami K, Breskovic T, Sikiric I, Dukkipati SR, Kawamura I, Neuzil P. Pulsed Field Ablation in Patients With Persistent Atrial Fibrillation. J Am Coll Cardiol. 2020 Sep 1;76(9):1068-1080. doi: 10.1016/j.jacc.2020.07.007.

  PMID: 32854842 BACKGROUND

• Calkins H, Gache L, Frame D, Boo LM, Ghaly N, Schilling R, Deering T, Duytschaever M, Packer DL. Predictive value of atrial fibrillation during the postradiofrequency ablation blanking period. Heart Rhythm. 2021 Mar;18(3):366-373. doi: 10.1016/j.hrthm.2020.11.020. Epub 2020 Nov 24.

  PMID: 33242668 BACKGROUND

• Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.

  PMID: 33933412 BACKGROUND

• Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-326. doi: 10.1016/j.jacc.2019.04.021. Epub 2019 May 11.

  PMID: 31085321 BACKGROUND

• Kawamura I, Neuzil P, Shivamurthy P, Petru J, Funasako M, Minami K, Kuroki K, Dukkipati SR, Koruth JS, Reddy VY. Does pulsed field ablation regress over time? A quantitative temporal analysis of pulmonary vein isolation. Heart Rhythm. 2021 Jun;18(6):878-884. doi: 10.1016/j.hrthm.2021.02.020. Epub 2021 Feb 27.

  PMID: 33647464 BACKGROUND

• Stewart MT, Haines DE, Verma A, Kirchhof N, Barka N, Grassl E, Howard B. Intracardiac pulsed field ablation: Proof of feasibility in a chronic porcine model. Heart Rhythm. 2019 May;16(5):754-764. doi: 10.1016/j.hrthm.2018.10.030. Epub 2018 Oct 30.

  PMID: 30385383 BACKGROUND

• Kim YG, Boo KY, Choi JI, Choi YY, Choi HY, Roh SY, Shim J, Kim JS, Kim YH. Early Recurrence Is Reliable Predictor of Late Recurrence After Radiofrequency Catheter Ablation of Atrial Fibrillation. JACC Clin Electrophysiol. 2021 Mar;7(3):343-351. doi: 10.1016/j.jacep.2020.09.029. Epub 2021 Jan 27.

  PMID: 33516711 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Recurrence

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lucija Lisica, MD

CONTACT

+385995094697; lucijalisica21@gmail.com

Zrinka Jurišić, Ass. Prof., MD

CONTACT

+385915262844; zrinkacn@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: November 17, 2021
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available immediately after the publication of the study.
• Access Criteria: The plan will be shared with other researchers who wish to replicate the study or study the protocol in detail.

Locations

CR (1)