Radiofrequency vs Cryoballoon Ablation for Atrial Fibrillation Assessed by Implantable Cardiac Monitor

NCT03805555 | Completed DMC

• 1 other identifier: H-2-2014-013
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a prospective randomized comparison of two methods of catheter ablation of atrial fibrillation: Radiofrequency ablation which is the standard of care will be compared to Cryoballoon ablation to perform pulmonary vein isolation. Primary endpoint for the randomized comparison is the number of pulmonary veins that remain isolated on follow up investigation. All patients will receive an implantable loop recorder to monitor clinical response and identify patients who benefit the most from durable pulmonary vein isolation. All patients will undergo a follow-up invasive assessment of pulmonary vein isolation, and veins with reconnection will be re-isolated to determine if this strategy alters clinical long-term outcome of ablation.

Conditions

Atrial Fibrillation

Keywords

ablation

Outcome Measures

Primary Outcomes (1)

• Number of veins with durable isolation assessed by invasive follow-up 4-6 months after the index procedure.

  For all patients: at the earliest 4 months and the latest 6 months after the initial pulmonary vein isolation, follow-up invasive assessment of bidirectional (entrance and exit) block to all pulmonary veins are performed using 3D computer mapping, and the number of veins without electrical reconnection (i.e. with durable isolation) are carefully recorded.

  4-6 months

Secondary Outcomes (6)

• Treatment failure constituted by the recurrence of atrial fibrillation (AF) after the blanking period (i.e. after the first 3 months following the index procedure).

  4-6 months

• Number of patients where procedural endpoint is met: all pulmonary veins isolated and observed isolated for 20 minutes.

  During index procedure

• Duration of the index procedure

  During index procedure

• X-ray exposure from the index procedure

  During index procedure

• Number of patients with procedure related complications.

  0-3 months

Other Outcomes (1)

• Reduction in AF-burden

  2 years

Study Arms (2)

Radiofrequency ablation

ACTIVE COMPARATOR

Best radiofrequency ablation

Procedure: Radiofrequency ablation

Cryoballoon ablation

EXPERIMENTAL

Best cryoballoon ablation

Procedure: Cryoballoon ablation

Interventions

Radiofrequency ablation PROCEDURE

Pulmonary vein isolation by radiofrequency ablation

Radiofrequency ablation

Cryoballoon ablation PROCEDURE

Pulmonary vein isolation by cryoballoon ablation

Cryoballoon ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Paroxysmal atrial fibrillation
• \>2 episodes in 3 months prior to enrollment
• Clinical indication for ablation

You may not qualify if:

• Contraindication for ablation
• Valvular heart disease
• Persistent AF only (\>7 days duration or \<7 days duration but requiring cardioversion, as persistent AF was customarily defined at the beginning of this study)
• Documented atrial flutter or other arrhythmias requiring other ablation than PVI
• Implanted pacemaker or defibrillator
• Pregnancy
• Malignant disease (non metastatic skin cancer excluded)
• Obesity (BMI \>35)
• Uncontrolled hypertension (BT \> 160/100 mmHg on repeated measurements)
• Severe sleep apnea
• Active systemic infection
• Renal insufficiency with S-creatinin \> 150 micromol/l
• Psychiatric illness or substance abuse
• Participation in other clinical studies involving medical treatment

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Gentofte Hospital

Hellerup, 2820, Denmark

Location

Related Publications (13)

• Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. Europace. 2012 Apr;14(4):528-606. doi: 10.1093/europace/eus027. Epub 2012 Mar 1. No abstract available.

  PMID: 22389422 BACKGROUND

• Calkins H, Reynolds MR, Spector P, Sondhi M, Xu Y, Martin A, Williams CJ, Sledge I. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol. 2009 Aug;2(4):349-61. doi: 10.1161/CIRCEP.108.824789. Epub 2009 Jun 2.

  PMID: 19808490 BACKGROUND

• Jons C, Hansen PS, Johannessen A, Hindricks G, Raatikainen P, Kongstad O, Walfridsson H, Pehrson S, Almroth H, Hartikainen J, Petersen AK, Mortensen LS, Nielsen JC; MANTRA-PAF Investigators. The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial: clinical rationale, study design, and implementation. Europace. 2009 Jul;11(7):917-23. doi: 10.1093/europace/eup122. Epub 2009 May 15.

  PMID: 19447807 BACKGROUND

• Cosedis Nielsen J, Johannessen A, Raatikainen P, Hindricks G, Walfridsson H, Kongstad O, Pehrson S, Englund A, Hartikainen J, Mortensen LS, Hansen PS. Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation. N Engl J Med. 2012 Oct 25;367(17):1587-95. doi: 10.1056/NEJMoa1113566.

  PMID: 23094720 BACKGROUND

• Karasoy D, Gislason GH, Hansen J, Olesen JB, Torp-Pedersen C, Johannessen A, Hansen ML. Temporal changes in patient characteristics and prior pharmacotherapy in patients undergoing radiofrequency ablation of atrial fibrillation: a Danish nationwide cohort study. Europace. 2013 May;15(5):669-75. doi: 10.1093/europace/eus418. Epub 2013 Jan 2.

  PMID: 23284140 BACKGROUND

• Ganesan AN, Shipp NJ, Brooks AG, Kuklik P, Lau DH, Lim HS, Sullivan T, Roberts-Thomson KC, Sanders P. Long-term outcomes of catheter ablation of atrial fibrillation: a systematic review and meta-analysis. J Am Heart Assoc. 2013 Mar 18;2(2):e004549. doi: 10.1161/JAHA.112.004549.

  PMID: 23537812 BACKGROUND

• Di Biase L, Wang Y, Horton R, Gallinghouse GJ, Mohanty P, Sanchez J, Patel D, Dare M, Canby R, Price LD, Zagrodzky JD, Bailey S, Burkhardt JD, Natale A. Ablation of atrial fibrillation utilizing robotic catheter navigation in comparison to manual navigation and ablation: single-center experience. J Cardiovasc Electrophysiol. 2009 Dec;20(12):1328-35. doi: 10.1111/j.1540-8167.2009.01570.x.

  PMID: 19656244 BACKGROUND

• Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jais P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012 Nov;9(11):1789-95. doi: 10.1016/j.hrthm.2012.07.016. Epub 2012 Jul 20.

  PMID: 22820056 BACKGROUND

• Andrade JG, Khairy P, Guerra PG, Deyell MW, Rivard L, Macle L, Thibault B, Talajic M, Roy D, Dubuc M. Efficacy and safety of cryoballoon ablation for atrial fibrillation: a systematic review of published studies. Heart Rhythm. 2011 Sep;8(9):1444-51. doi: 10.1016/j.hrthm.2011.03.050. Epub 2011 Mar 30. No abstract available.

  PMID: 21457789 BACKGROUND

• Kojodjojo P, O'Neill MD, Lim PB, Malcolm-Lawes L, Whinnett ZI, Salukhe TV, Linton NW, Lefroy D, Mason A, Wright I, Peters NS, Kanagaratnam P, Davies DW. Pulmonary venous isolation by antral ablation with a large cryoballoon for treatment of paroxysmal and persistent atrial fibrillation: medium-term outcomes and non-randomised comparison with pulmonary venous isolation by radiofrequency ablation. Heart. 2010 Sep;96(17):1379-84. doi: 10.1136/hrt.2009.192419.

  PMID: 20801856 BACKGROUND

• Hindricks G, Pokushalov E, Urban L, Taborsky M, Kuck KH, Lebedev D, Rieger G, Purerfellner H; XPECT Trial Investigators. Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: Results of the XPECT trial. Circ Arrhythm Electrophysiol. 2010 Apr;3(2):141-7. doi: 10.1161/CIRCEP.109.877852. Epub 2010 Feb 16.

  PMID: 20160169 BACKGROUND

• Sorensen SK, Johannessen A, Worck R, Hansen ML, Ruwald MH, Hansen J. Differential gap location after radiofrequency versus cryoballoon pulmonary vein isolation: Insights from a randomized trial with protocol-mandated repeat procedure. J Cardiovasc Electrophysiol. 2023 Mar;34(3):519-526. doi: 10.1111/jce.15821. Epub 2023 Jan 22.

  PMID: 36640430 DERIVED

• Sorensen SK, Johannessen A, Worck R, Hansen ML, Hansen J. Radiofrequency Versus Cryoballoon Catheter Ablation for Paroxysmal Atrial Fibrillation: Durability of Pulmonary Vein Isolation and Effect on Atrial Fibrillation Burden: The RACE-AF Randomized Controlled Trial. Circ Arrhythm Electrophysiol. 2021 May;14(5):e009573. doi: 10.1161/CIRCEP.120.009573. Epub 2021 Apr 9.

  PMID: 33835823 DERIVED

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

• Jim Hansen, MD

  UH Gentofte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMSc, Director of Cardiac Electrophysiology

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: January 15, 2019
• Study Start: June 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: October 1, 2020
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)