Ablation of Fibrotic Areas in Patients With Persistent Atrial Fibrillation.

NCT04377594 | Active Not Recruiting

• 1 other identifier: 200212IDEALAF
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Brief summary: The objective of this study is to compare two different ablation strategies in participants with persistent atrial fibrillation and fibrotic areas in the left atrium. The participant will be randomized to pulmonary vein isolation or pulmonary vein isolation plus ablation of fibrotic areas.

Conditions

Atrial Fibrillation

Keywords

Catheter ablation; Low voltage

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Freedom from Atrial Arrhythmia

  Freedom from documented atrial arrhythmias \>30 seconds at 12 months after 1 or 2 ablation procedures within 6 months without antiarrhythmic drugs

  From 3 months (blanking period) to 12 months after the first ablation procedure

Secondary Outcomes (16)

• Number of Participants with Freedom from Atrial Arrhythmia after 1 Ablation Procedure without Antiarrhythmic Drugs (AAD)

  From 3 months (blanking period) to 12 months after the first ablation procedure

• Number of Participants with Freedom from Atrial Arrhythmia after 1 Ablation Procedure with/ without AAD

  From 3 months (blanking period) to 12 months after the first ablation procedure

• Number of Participants with Freedom from Atrial Arrhythmia after 1 or 2 Ablation Procedures with/ without AAD

  From 3 months (blanking period) to 12 months after the first ablation procedure

• Number of Participants with Freedom from Atrial Fibrillation

  From 3 months (blanking period) to 12 months after the first ablation procedure

• Number of Participants with Freedom from Symptomatic Atrial Arrhythmias

  From 3 months (blanking period) to 12 months after the first ablation procedure

Study Arms (2)

Pulmonary vein isolation plus substrate modification

EXPERIMENTAL

Pulmonary vein isolation plus ablation of low voltage areas in the left atrium

Procedure: Radio frequency ablation

Pulmonary vein isolation

ACTIVE COMPARATOR

Pulmonary vein isolation

Procedure: Radio frequency ablation

Interventions

Radio frequency ablation PROCEDURE

Two different radio frequency ablation procedures

Pulmonary vein isolation; Pulmonary vein isolation plus substrate modification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECG-documented persistent or long-standing persistent atrial fibrillation according to European Society of Cardiology (ESC) definition
• Symptoms e. g. palpitations, dyspnea, tiredness that is due to the atrial fibrillation.
• Suitable candidate for catheter ablation.
• Tried one or more antiarrhythmic drugs or unwilling to try antiarrhythmic drugs
• Age ≥18 years.

You may not qualify if:

• LA dimension \>55 mm as determined by an echocardiography within the previous year
• Acute coronary syndrome or coronary artery bypass surgery within 12 weeks
• Severe aortic or mitral valvular heart disease using the ESC guidelines
• Congenital heart disease
• Prior surgical or percutaneous AF ablation procedure or atrioventricular-nodal ablation
• Medical condition likely to limit survival to \< 1 year
• New York Heart Association (NYHA) class IV heart failure symptoms
• Contraindication to oral anticoagulation
• Renal failure requiring dialysis
• AF due to reversible cause
• Pregnant and fertile women without anticonception
• History of non-compliance to medical therapy
• Unable or unwilling to provide informed consent

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, Stockholm County, SE-14186, Sweden

Location

Related Publications (13)

• Lloyd-Jones DM, Wang TJ, Leip EP, Larson MG, Levy D, Vasan RS, D'Agostino RB, Massaro JM, Beiser A, Wolf PA, Benjamin EJ. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004 Aug 31;110(9):1042-6. doi: 10.1161/01.CIR.0000140263.20897.42. Epub 2004 Aug 16.

  PMID: 15313941 BACKGROUND

• Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.

  PMID: 27567408 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

• Tilz RR, Rillig A, Thum AM, Arya A, Wohlmuth P, Metzner A, Mathew S, Yoshiga Y, Wissner E, Kuck KH, Ouyang F. Catheter ablation of long-standing persistent atrial fibrillation: 5-year outcomes of the Hamburg Sequential Ablation Strategy. J Am Coll Cardiol. 2012 Nov 6;60(19):1921-9. doi: 10.1016/j.jacc.2012.04.060. Epub 2012 Oct 10.

  PMID: 23062545 BACKGROUND

• Scherr D, Khairy P, Miyazaki S, Aurillac-Lavignolle V, Pascale P, Wilton SB, Ramoul K, Komatsu Y, Roten L, Jadidi A, Linton N, Pedersen M, Daly M, O'Neill M, Knecht S, Weerasooriya R, Rostock T, Manninger M, Cochet H, Shah AJ, Yeim S, Denis A, Derval N, Hocini M, Sacher F, Haissaguerre M, Jais P. Five-year outcome of catheter ablation of persistent atrial fibrillation using termination of atrial fibrillation as a procedural endpoint. Circ Arrhythm Electrophysiol. 2015 Feb;8(1):18-24. doi: 10.1161/CIRCEP.114.001943. Epub 2014 Dec 20.

  PMID: 25528745 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

• Oakes RS, Badger TJ, Kholmovski EG, Akoum N, Burgon NS, Fish EN, Blauer JJ, Rao SN, DiBella EV, Segerson NM, Daccarett M, Windfelder J, McGann CJ, Parker D, MacLeod RS, Marrouche NF. Detection and quantification of left atrial structural remodeling with delayed-enhancement magnetic resonance imaging in patients with atrial fibrillation. Circulation. 2009 Apr 7;119(13):1758-67. doi: 10.1161/CIRCULATIONAHA.108.811877. Epub 2009 Mar 23.

  PMID: 19307477 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

• Yagishita A, Sparano D, Cakulev I, Gimbel JR, Phelan T, Mustafa H, De Oliveira S, Mackall J, Arruda M. Identification and electrophysiological characterization of early left atrial structural remodeling as a predictor for atrial fibrillation recurrence after pulmonary vein isolation. J Cardiovasc Electrophysiol. 2017 Jun;28(6):642-650. doi: 10.1111/jce.13211. Epub 2017 May 29.

  PMID: 28387462 BACKGROUND

• Schreiber D, Rieger A, Moser F, Kottkamp H. Catheter ablation of atrial fibrillation with box isolation of fibrotic areas: Lessons on fibrosis distribution and extent, clinical characteristics, and their impact on long-term outcome. J Cardiovasc Electrophysiol. 2017 Sep;28(9):971-983. doi: 10.1111/jce.13278. Epub 2017 Jul 5.

  PMID: 28635186 BACKGROUND

• Kottkamp H, Bender R, Berg J. Catheter ablation of atrial fibrillation: how to modify the substrate? J Am Coll Cardiol. 2015 Jan 20;65(2):196-206. doi: 10.1016/j.jacc.2014.10.034.

  PMID: 25593061 BACKGROUND

• Phlips T, Taghji P, El Haddad M, Wolf M, Knecht S, Vandekerckhove Y, Tavernier R, Duytschaever M. Improving procedural and one-year outcome after contact force-guided pulmonary vein isolation: the role of interlesion distance, ablation index, and contact force variability in the 'CLOSE'-protocol. Europace. 2018 Nov 1;20(FI_3):f419-f427. doi: 10.1093/europace/eux376.

  PMID: 29315411 BACKGROUND

• El Haddad M, Taghji P, Phlips T, Wolf M, Demolder A, Choudhury R, Knecht S, Vandekerckhove Y, Tavernier R, Nakagawa H, Duytschaever M. Determinants of Acute and Late Pulmonary Vein Reconnection in Contact Force-Guided Pulmonary Vein Isolation: Identifying the Weakest Link in the Ablation Chain. Circ Arrhythm Electrophysiol. 2017 Apr;10(4):e004867. doi: 10.1161/CIRCEP.116.004867.

  PMID: 28381417 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Mats Jensen-Urstad, MD

  Karolinska University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomization 1:1

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: May 6, 2020
• Study Start: May 20, 2020
• Primary Completion: April 11, 2026
• Study Completion: April 11, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)