NCT02426710

Brief Summary

Background: Radiofrequency ablation of typical atrial flutter present the most effective treament option in treatment of atrial flutter. Despite its high efficacy, due tovariant anatomy of cavotricuspid isthmus (CTI), i.e. location of right coronary artery, pouches, the achievment of complete bidirectional block across the CTI is sometimes chalenging. Intracardiac echocardiography (ICE) is a very usefull tool for on-line vizualization of the anatomy of the atria and also for the location of catheter position on CTI during ablation. If the routine use of ICE is associated with easier atrial fluter ablation is not clear. Methods: One hundred consecutive patients indicated for typical atrial flutter ablation will be enrolled into the study. The patients will be randomized into group (A) ablation with use of ICE and (B) ablation without ICE. The ablation will be done in both groups by two diagnostic catheters (10-pole positioned in coronary sinus and 20-pole halo catheter positioned in the right atrium) and radiofrequency ablation catheter. The end-point of the ablation is the achievment of the bicidrectional block across the CTI. The end-points of the study are 1) the total length of the procedure, 2) the fluoroscopy time and 3) the ablation time. The safety end-point is clinically significant bleeding from the groin due to additional puncture for ICE catheter. Discussion: We hypothesize the use of ICE wil shorten the radiofrequency energy delivery, fluoroscopy time and the length of the procedure without increasing the bleeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

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

June 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2017

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

April 22, 2015

Last Update Submit

January 29, 2019

Conditions

ATRIAL FLUTTER

Keywords

ablation, atrial flutter, intracardiac echocardiography

Outcome Measures

Primary Outcomes (4)

  • Procedure duration

    The total lenght of the procedure in minuts will be measured.

    intraoperative

  • Fluoroscopy time during ablation

    The total fluoroscopy time will be measured.

    intraoperative

  • Total ablation time

    The time of radiofrequenc energy delivery during ablation will me measured.

    intraoperative

  • Bleeding

    The bleeding complication required intervention or prolonged hospitalization will be measured.

    24 hours

Study Arms (2)

Flutter ablation with intracardiac echocardiography

EXPERIMENTAL

Atrial flutter ablation will be done using intracardiac echocardiography.

Device: Intracardiac echocardiography

Flutter ablation without intracardiac echocardiography

ACTIVE COMPARATOR

Atrial flutter ablation will be done without intracardiac echocardiography.

Device: Intracardiac echocardiography

Interventions

Intracardiac echocardiographyDEVICE

Flutter ablation will be done using intracardiac echocardiography.

Flutter ablation with intracardiac echocardiographyFlutter ablation without intracardiac echocardiography

Eligibility Criteria

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

You may qualify if:

  • indication for atrial flutter ablation

You may not qualify if:

  • history of recent femoral vein thrombosis (within last 6 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

Location

Related Publications (7)

  • Scaglione M, Caponi D, Di Donna P, Riccardi R, Bocchiardo M, Azzaro G, Leuzzi S, Gaita F. Typical atrial flutter ablation outcome: correlation with isthmus anatomy using intracardiac echo 3D reconstruction. Europace. 2004 Sep;6(5):407-17. doi: 10.1016/j.eupc.2004.05.008.

    PMID: 15294265BACKGROUND

  • Lee G, Sanders P, Kalman JM. Catheter ablation of atrial arrhythmias: state of the art. Lancet. 2012 Oct 27;380(9852):1509-19. doi: 10.1016/S0140-6736(12)61463-9.

    PMID: 23101718RESULT

  • Schumacher B, Pfeiffer D, Tebbenjohanns J, Lewalter T, Jung W, Luderitz B. Acute and long-term effects of consecutive radiofrequency applications on conduction properties of the subeustachian isthmus in type I atrial flutter. J Cardiovasc Electrophysiol. 1998 Feb;9(2):152-63. doi: 10.1111/j.1540-8167.1998.tb00896.x.

    PMID: 9511889RESULT

  • Gami AS, Edwards WD, Lachman N, Friedman PA, Talreja D, Munger TM, Hammill SC, Packer DL, Asirvatham SJ. Electrophysiological anatomy of typical atrial flutter: the posterior boundary and causes for difficulty with ablation. J Cardiovasc Electrophysiol. 2010 Feb;21(2):144-9. doi: 10.1111/j.1540-8167.2009.01607.x. Epub 2009 Oct 5.

    PMID: 19804553RESULT

  • Lai LP, Lin JL, Lin JM, Du CC, Tseng YZ, Huang SK. Use of double-potential barrier to identify functional isthmus at the cavotricuspid isthmus for facilitating catheter ablation of isthmus-dependent atrial flutter. J Cardiovasc Electrophysiol. 2004 Apr;15(4):396-401. doi: 10.1046/j.1540-8167.2004.03424.x.

    PMID: 15089986RESULT

  • Al Aloul B, Sigurdsson G, Can I, Li JM, Dykoski R, Tholakanahalli VN. Proximity of right coronary artery to cavotricuspid isthmus as determined by computed tomography. Pacing Clin Electrophysiol. 2010 Nov;33(11):1319-23. doi: 10.1111/j.1540-8159.2010.02844.x.

    PMID: 20663073RESULT

  • Morton JB, Sanders P, Davidson NC, Sparks PB, Vohra JK, Kalman JM. Phased-array intracardiac echocardiography for defining cavotricuspid isthmus anatomy during radiofrequency ablation of typical atrial flutter. J Cardiovasc Electrophysiol. 2003 Jun;14(6):591-7. doi: 10.1046/j.1540-8167.2003.02152.x.

    PMID: 12875419RESULT

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RAndomization to ICE or no ICE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiocenter, III rd internal-cardiology clinic

Study Record Dates

First Submitted

April 22, 2015

First Posted

April 27, 2015

Study Start

June 1, 2014

Primary Completion

April 10, 2017

Study Completion

April 10, 2017

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Study was published

Locations

CZ(1)