Clinical and Electrophysiological Predictors of Arrhythmic Recurrence in Patients With Paroxysmal AF Undergoing First Ablation Procedure of AF by Pulmonary Vein Isolation

NCT ID: NCT06085014

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-06
• Study Completion Date: 2024-09-30

Brief Summary

From the literature, the success rate (i.e., absence of AF recurrence) of ablation in cases of paroxysmal AF at one year changes between 70 and 85 percent. This rate is considered suboptimal. Currently there are no data that can assess which factors are predictive of recurrence both clinically and electrophysiologically. In particular, it is not known whether and to what extent the atrial substrate present under baseline conditions affects the success rate of the procedure and what relationships exist with other predictors such as age, sex, atrial size at echo, and duration of arrhythmia.

Detailed Description

This is a multicenter prospective and retrospective observational study aimed at examining the role of the left atrial substrate and other baseline clinical variables on the efficacy of transcatheter ablation in patients with paroxysmal atrial fibrillation (AF) who underwent pulmonary vein isolation regardless of the power source and balloon or "point by point" catheters used.

The study will evaluate whether there are baseline clinical or electrophysiological features that can predict the success of transcatheter atrial fibrillation ablation even before it is performed, so as to assess which patients may actually benefit, and which patients should instead undergo more extensive ablative procedures in conjunction with pulmonary vein isolation to achieve an optimal success rate.

Conditions

Atrial Fibrillation Paroxysmal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Prospective cohort

Patients with paroxysmal AF with clinical indication to first transcatheter ablation procedure of AF by pulmonary vein isolation

Standard of care

Intervention Type: OTHER

All patients will undergo, as clinically indicated, AF ablation by pulmonary vein isolation achievable by radiofrequency, cryoenergy, or electroporation. All patients will preliminarily undergo electroanatomic mapping of the atrium by CARTO/Navx/Rhythmia system indifferently. Patients will be given follow-up visits at 3-6-12 months, during which any arrhythmic recurrences will be assessed

Retrospective cohort

Patients who underwent ablative procedure in the two years prior to the start of the study

Data collection

Intervention Type: OTHER

There's no patient involvement. Data of patients who underwent ablative procedures two years before the start of the study will be retrospectively analyzed

Interventions

Standard of care

All patients will undergo, as clinically indicated, AF ablation by pulmonary vein isolation achievable by radiofrequency, cryoenergy, or electroporation. All patients will preliminarily undergo electroanatomic mapping of the atrium by CARTO/Navx/Rhythmia system indifferently. Patients will be given follow-up visits at 3-6-12 months, during which any arrhythmic recurrences will be assessed

Intervention Type: OTHER

Data collection

There's no patient involvement. Data of patients who underwent ablative procedures two years before the start of the study will be retrospectively analyzed

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with indication for AF ablation
• Adequate anticoagulation therapy according to CHADs VASC

Exclusion Criteria

• patients who had already undergo an AF ablation procedure
• Presence of intracavitary thrombus
• Ejection fraction <35%
• Pregnancy
• Hematologic contraindications to ionizing radiation exposure
• Congenital heart diseases
• Cardiac Surgery < 1month
• Uncontrolled heart failure
• Valvular disease
• Contraindications to general anesthesia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero, Universitaria Ospedali Riuniti

OTHER

Sponsor Role: collaborator

Centro Cardiologico Monzino

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefania Riva, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Centro Cardiologico Monzino

Locations

Azienda Ospedaliera Universitaria delle Marche

Ancona, , Italy

Site Status: NOT_YET_RECRUITING

IRCCS Centro Cardiologico Monzino

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stefania Riva, MD

Role: CONTACT

stefania.riva@cardiologicomonzino.it

02 58002584

Lorenzo Bianchini, MD

Role: CONTACT

lorenzo.bianchini@cardiologicomonzino.it

Facility Contacts

Michela Casella, Prof

Role: primary

m.casella@staff.univpm.it

Stefania Riva, MD

Role: primary

stefania.riva@cardiologicomonzino.it

02 58002584

References

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, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, 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. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available.

Reference Type: BACKGROUND

PMID: 28506916 (View on PubMed)

Verma A, Wazni OM, Marrouche NF, Martin DO, Kilicaslan F, Minor S, Schweikert RA, Saliba W, Cummings J, Burkhardt JD, Bhargava M, Belden WA, Abdul-Karim A, Natale A. Pre-existent left atrial scarring in patients undergoing pulmonary vein antrum isolation: an independent predictor of procedural failure. J Am Coll Cardiol. 2005 Jan 18;45(2):285-92. doi: 10.1016/j.jacc.2004.10.035.

Reference Type: BACKGROUND

PMID: 15653029 (View on PubMed)

Rolf S, Kircher S, Arya A, Eitel C, Sommer P, Richter S, Gaspar T, Bollmann A, Altmann D, Piedra C, Hindricks G, Piorkowski C. Tailored atrial substrate modification based on low-voltage areas in catheter ablation of atrial fibrillation. Circ Arrhythm Electrophysiol. 2014 Oct;7(5):825-33. doi: 10.1161/CIRCEP.113.001251. Epub 2014 Aug 23.

Reference Type: BACKGROUND

PMID: 25151631 (View on PubMed)

Tijskens M, Bergonti M, Spera F, Ascione C, Saenen J, Huybrechts W, Miljoen H, Riva S, Wittock A, Heidbuchel H, Tondo C, Sarkozy A. Etiology and Outcome of Catheter Ablation in Patients With Onset of Atrial Fibrillation <45 Years of Age. Am J Cardiol. 2022 Mar 1;166:45-52. doi: 10.1016/j.amjcard.2021.11.030. Epub 2021 Dec 24.

Reference Type: BACKGROUND

PMID: 34961604 (View on PubMed)

Vlachos K, Efremidis M, Letsas KP, Bazoukis G, Martin R, Kalafateli M, Lioni L, Georgopoulos S, Saplaouras A, Efremidis T, Liu T, Valkanas K, Karamichalakis N, Asvestas D, Sideris A. Low-voltage areas detected by high-density electroanatomical mapping predict recurrence after ablation for paroxysmal atrial fibrillation. J Cardiovasc Electrophysiol. 2017 Dec;28(12):1393-1402. doi: 10.1111/jce.13321. Epub 2017 Sep 8.

Reference Type: BACKGROUND

PMID: 28884923 (View on PubMed)

Kirstein B, Neudeck S, Gaspar T, Piorkowski J, Wechselberger S, Kronborg MB, Zedda A, Hankel A, El-Armouche A, Tomala J, Schmidt T, Mayer J, Wagner M, Ulbrich S, Pu L, Richter U, Huo Y, Piorkowski C. Left atrial fibrosis predicts left ventricular ejection fraction response after atrial fibrillation ablation in heart failure patients: the Fibrosis-HF Study. Europace. 2020 Dec 23;22(12):1812-1821. doi: 10.1093/europace/euaa179.

Reference Type: BACKGROUND

PMID: 32830233 (View on PubMed)

Bergonti M, Spera FR, Ferrero TG, Nsahlai M, Bonomi A, Tijskens M, Boris W, Saenen J, Huybrechts W, Miljoen H, Gonzalez-Juanatey JR, Martinez-Sande JL, Vandaele L, Wittock A, Heidbuchel H, Valderrabano M, Rodriguez-Manero M, Sarkozy A. Characterization of Atrial Substrate to Predict the Success of Pulmonary Vein Isolation: The Prospective, Multicenter MASH-AF II (Multipolar Atrial Substrate High Density Mapping in Atrial Fibrillation) Study. J Am Heart Assoc. 2023 Jan 3;12(1):e027795. doi: 10.1161/JAHA.122.027795. Epub 2022 Dec 24.

Reference Type: BACKGROUND

PMID: 36565183 (View on PubMed)

Other Identifiers

CCM 1981

Identifier Type: -

Identifier Source: org_study_id