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

NCT06085014 | Unknown

• 1 other identifier: CCM 1981
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation Paroxysmal

Keywords

pulmonary vein isolation; atrial fibrillation; catheter ablation; electroanatomical map

Outcome Measures

Primary Outcomes (1)

• Assess clinical and electrophysiological predictors of arrhythmic recurrence

  Evaluate the role of atrial disease, assessed by baseline electroanatomic mapping, age, gender, echocardiographic data, years from first AF episode, in predicting AF recurrence after AF ablation.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Evaluate acute and mid- to long-term efficacy, safety, and procedural timing of different technologies

  through study completion, an average of 1 year

Study Arms (2)

Prospective cohort

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

Other: Standard of care

Retrospective cohort

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

Other: Data collection

Interventions

Standard of care 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

Prospective cohort

Data collection 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

Retrospective cohort

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Azienda Ospedaliero, Universitaria Ospedali Riuniti: collaborator

Study Sites (2)

Azienda Ospedaliera Universitaria delle Marche

Ancona, 60126, Italy

NOT YET RECRUITING

IRCCS Centro Cardiologico Monzino

Milan, 20138, Italy

RECRUITING

Related Publications (7)

• 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.

  PMID: 28506916 BACKGROUND

• 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.

  PMID: 15653029 BACKGROUND

• 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.

  PMID: 25151631 BACKGROUND

• 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.

  PMID: 34961604 BACKGROUND

• 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.

  PMID: 28884923 BACKGROUND

• 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.

  PMID: 32830233 BACKGROUND

• 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.

  PMID: 36565183 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Standard of Care; Data Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Stefania Riva, MD

  IRCCS Centro Cardiologico Monzino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefania Riva, MD

CONTACT

02 58002584; stefania.riva@cardiologicomonzino.it

Lorenzo Bianchini, MD

CONTACT

lorenzo.bianchini@cardiologicomonzino.it

Study Design

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

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 16, 2023
• Study Start: September 6, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

IT (2)