NCT03008811

Brief Summary

This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment of patients with persistent or longstanding persistent atrial fibrillation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

November 12, 2021

Status Verified

February 1, 2020

Enrollment Period

4.4 years

First QC Date

November 23, 2016

Last Update Submit

November 11, 2021

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial FibrillationCatheter Ablation

Outcome Measures

Primary Outcomes (1)

  • The freedom of any atrial arrhythmias at 12 months.

    The primary endpoint is freedom of any atrial arrhythmias at 12 months (at least one episode of atrial fibrillation, or atrial flutter or atrial tachycardia with a duration \> 30 seconds documented by 7-day Holter ECG, or any other printed ECG recording).

    12 months

Secondary Outcomes (10)

  • Procedure duration

    12 months

  • Fluoroscopy time

    12 months

  • Ablation time

    12 months

  • Quality of life - Short Form (SF-36) Heath Survey

    12 months.

  • Quality of life affected by atrial fibrillation.

    12 months.

  • +5 more secondary outcomes

Study Arms (2)

Cryoballoon

ACTIVE COMPARATOR

Pulmonary vein isolation with cryoballoon catheter.

Procedure: Pulmonary vein isolation with cryoballoon catheter.

Radiofrequency

ACTIVE COMPARATOR

Pulmonary vein isolation with radiofrequency ablation catheter.

Procedure: Pulmonary vein isolation with radiofrequency ablation.

Interventions

Pulmonary vein isolation with cryoballoon catheter.PROCEDURE

Device: Arctic Front Advance™ cardiac cryoablation catheter system.

Cryoballoon
Pulmonary vein isolation with radiofrequency ablation.PROCEDURE

Device: TactiCath™ Quartz irrigated ablation catheter (St. Jude Medical) with aid of 3-D mapping system (EnSite Precision, St. Jude Medical).

Radiofrequency

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients plan to undergo pulmonary vein isolation as the first procedure for symptomatic persistent atrial fibrillation (\>7 days) and longstanding persistent atrial fibrillation (\> 12 months, but ≤ 3 years) who are refractory to at least one class I or class III antiarrhythmic drug and required at least one electrical or pharmacologic cardioversion.
  • Subject is at least 18 and ≤ 75 years old.
  • Subject is able and willing to give informed consent.

You may not qualify if:

  • Subject has paroxysmal atrial fibrillation (\< 7days) or persistent atrial fibrillation with duration \> 3 years.
  • Subject has any previous left atrial ablation procedure or surgery, including pulmonary vein isolation.
  • Subject has presence of an intracavitary thrombus.
  • Subject has uncontrolled heart failure.
  • Subject has severe valvular disease.
  • Subject has the left atrial diameter \> 60 mm confirmed by echocardiography.
  • Subject has contraindications to systemic anticoagulation with heparin or oral anticoagulants.
  • Subject has known cryoglobulinaemia.
  • Subject has severe renal dysfunction.
  • Subject who is or may potentially be pregnant.
  • Subject has unstable angina pectoris.
  • Subject has history of previous myocardial infarction or percutaneous intervention during the last three months.
  • Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Haukeland University Hospital

Bergen, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (18)

  • Camm AJ, Obel OA. Epidemiology and mechanism of atrial fibrillation and atrial flutter. Am J Cardiol. 1996 Oct 17;78(8A):3-11. doi: 10.1016/s0002-9149(96)00559-0. No abstract available.

    PMID: 8903269BACKGROUND

  • Biblo LA, Yuan Z, Quan KJ, Mackall JA, Rimm AA. Risk of stroke in patients with atrial flutter. Am J Cardiol. 2001 Feb 1;87(3):346-9, A9. doi: 10.1016/s0002-9149(00)01374-6.

    PMID: 11165976BACKGROUND

  • Vidaillet H, Granada JF, Chyou Po, Maassen K, Ortiz M, Pulido JN, Sharma P, Smith PN, Hayes J. A population-based study of mortality among patients with atrial fibrillation or flutter. Am J Med. 2002 Oct 1;113(5):365-70. doi: 10.1016/s0002-9343(02)01253-6.

    PMID: 12401530BACKGROUND

  • Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.

    PMID: 9737513BACKGROUND

  • Wolf PA, Mitchell JB, Baker CS, Kannel WB, D'Agostino RB. Impact of atrial fibrillation on mortality, stroke, and medical costs. Arch Intern Med. 1998 Feb 9;158(3):229-34. doi: 10.1001/archinte.158.3.229.

    PMID: 9472202BACKGROUND

  • Corley SD, Epstein AE, DiMarco JP, Domanski MJ, Geller N, Greene HL, Josephson RA, Kellen JC, Klein RC, Krahn AD, Mickel M, Mitchell LB, Nelson JD, Rosenberg Y, Schron E, Shemanski L, Waldo AL, Wyse DG; AFFIRM Investigators. Relationships between sinus rhythm, treatment, and survival in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Study. Circulation. 2004 Mar 30;109(12):1509-13. doi: 10.1161/01.CIR.0000121736.16643.11. Epub 2004 Mar 8.

    PMID: 15007003BACKGROUND

  • Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003.

    PMID: 9725923BACKGROUND

  • Verma A, Marrouche NF, Natale A. Pulmonary vein antrum isolation: intracardiac echocardiography-guided technique. J Cardiovasc Electrophysiol. 2004 Nov;15(11):1335-40. doi: 10.1046/j.1540-8167.2004.04428.x.

    PMID: 15574190BACKGROUND

  • Oral H, Scharf C, Chugh A, Hall B, Cheung P, Good E, Veerareddy S, Pelosi F Jr, Morady F. Catheter ablation for paroxysmal atrial fibrillation: segmental pulmonary vein ostial ablation versus left atrial ablation. Circulation. 2003 Nov 11;108(19):2355-60. doi: 10.1161/01.CIR.0000095796.45180.88. Epub 2003 Oct 13.

    PMID: 14557355BACKGROUND

  • Saad EB, Rossillo A, Saad CP, Martin DO, Bhargava M, Erciyes D, Bash D, Williams-Andrews M, Beheiry S, Marrouche NF, Adams J, Pisano E, Fanelli R, Potenza D, Raviele A, Bonso A, Themistoclakis S, Brachmann J, Saliba WI, Schweikert RA, Natale A. Pulmonary vein stenosis after radiofrequency ablation of atrial fibrillation: functional characterization, evolution, and influence of the ablation strategy. Circulation. 2003 Dec 23;108(25):3102-7. doi: 10.1161/01.CIR.0000104569.96907.7F. Epub 2003 Nov 17.

    PMID: 14623799BACKGROUND

  • Pappone C, Rosanio S, Augello G, Gallus G, Vicedomini G, Mazzone P, Gulletta S, Gugliotta F, Pappone A, Santinelli V, Tortoriello V, Sala S, Zangrillo A, Crescenzi G, Benussi S, Alfieri O. Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation: outcomes from a controlled nonrandomized long-term study. J Am Coll Cardiol. 2003 Jul 16;42(2):185-97. doi: 10.1016/s0735-1097(03)00577-1.

    PMID: 12875749BACKGROUND

  • Marrouche NF, Martin DO, Wazni O, Gillinov AM, Klein A, Bhargava M, Saad E, Bash D, Yamada H, Jaber W, Schweikert R, Tchou P, Abdul-Karim A, Saliba W, Natale A. Phased-array intracardiac echocardiography monitoring during pulmonary vein isolation in patients with atrial fibrillation: impact on outcome and complications. Circulation. 2003 Jun 3;107(21):2710-6. doi: 10.1161/01.CIR.0000070541.83326.15. Epub 2003 May 19.

    PMID: 12756153BACKGROUND

  • Haissaguerre M, Jais P, Shah DC, Arentz T, Kalusche D, Takahashi A, Garrigue S, Hocini M, Peng JT, Clementy J. Catheter ablation of chronic atrial fibrillation targeting the reinitiating triggers. J Cardiovasc Electrophysiol. 2000 Jan;11(1):2-10. doi: 10.1111/j.1540-8167.2000.tb00727.x.

    PMID: 10695453BACKGROUND

  • Ullah W, Hunter RJ, Haldar S, McLean A, Dhinoja M, Sporton S, Earley MJ, Lorgat F, Wong T, Schilling RJ. Comparison of robotic and manual persistent AF ablation using catheter contact force sensing: an international multicenter registry study. Pacing Clin Electrophysiol. 2014 Nov;37(11):1427-35. doi: 10.1111/pace.12501. Epub 2014 Sep 15.

    PMID: 25220575BACKGROUND

  • Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.

    PMID: 25946280BACKGROUND

  • Liu J, Kaufmann J, Kriatselis C, Fleck E, Gerds-Li JH. Second generation of cryoballoons can improve efficiency of cryoablation for atrial fibrillation. Pacing Clin Electrophysiol. 2015 Jan;38(1):129-35. doi: 10.1111/pace.12538. Epub 2014 Dec 12.

    PMID: 25494851BACKGROUND

  • Jourda F, Providencia R, Marijon E, Bouzeman A, Hireche H, Khoueiry Z, Cardin C, Combes N, Combes S, Boveda S, Albenque JP. Contact-force guided radiofrequency vs. second-generation balloon cryotherapy for pulmonary vein isolation in patients with paroxysmal atrial fibrillation-a prospective evaluation. Europace. 2015 Feb;17(2):225-31. doi: 10.1093/europace/euu215. Epub 2014 Sep 3.

    PMID: 25186456BACKGROUND

  • Ciconte G, Ottaviano L, de Asmundis C, Baltogiannis G, Conte G, Sieira J, Di Giovanni G, Saitoh Y, Irfan G, Mugnai G, Storti C, Montenero AS, Chierchia GB, Brugada P. Pulmonary vein isolation as index procedure for persistent atrial fibrillation: One-year clinical outcome after ablation using the second-generation cryoballoon. Heart Rhythm. 2015 Jan;12(1):60-6. doi: 10.1016/j.hrthm.2014.09.063. Epub 2014 Oct 2.

    PMID: 25281891BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

January 2, 2017

Study Start

November 1, 2016

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

November 12, 2021

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(3)