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Intracardiac Echocardiography in Atrial Flutter Ablation (FLS-ICE-R)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426710
Recruitment Status : Completed
First Posted : April 27, 2015
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Pavel Osmancik, Charles University, Czech Republic

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.


Condition or disease Intervention/treatment Phase
ATRIAL FLUTTER Device: Intracardiac echocardiography Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RAndomization to ICE or no ICE
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Usefulness of Intracardiac Echocardiography in Atrial Flutter Ablation - a Randomized Study
Study Start Date : June 2014
Actual Primary Completion Date : April 10, 2017
Actual Study Completion Date : April 10, 2017

Arm Intervention/treatment
Experimental: Flutter ablation with intracardiac echocardiography
Atrial flutter ablation will be done using intracardiac echocardiography.
Device: Intracardiac echocardiography
Flutter ablation will be done using intracardiac echocardiography.

Active Comparator: Flutter ablation without intracardiac echocardiography
Atrial flutter ablation will be done without intracardiac echocardiography.
Device: Intracardiac echocardiography
Flutter ablation will be done using intracardiac echocardiography.




Primary Outcome Measures :
  1. Procedure duration [ Time Frame: intraoperative ]
    The total lenght of the procedure in minuts will be measured.

  2. Fluoroscopy time during ablation [ Time Frame: intraoperative ]
    The total fluoroscopy time will be measured.

  3. Total ablation time [ Time Frame: intraoperative ]
    The time of radiofrequenc energy delivery during ablation will me measured.

  4. Bleeding [ Time Frame: 24 hours ]
    The bleeding complication required intervention or prolonged hospitalization will be measured.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • indication for atrial flutter ablation

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426710


Locations
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Czechia
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, Czechia, 10034
Sponsors and Collaborators
Charles University, Czech Republic
Publications of Results:

Other Publications:
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Responsible Party: Pavel Osmancik, Cardiocenter, III rd internal-cardiology clinic, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT02426710    
Other Study ID Numbers: FLS-ICE randomized
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study was published
Keywords provided by Pavel Osmancik, Charles University, Czech Republic:
ablation, atrial flutter, intracardiac echocardiography
Additional relevant MeSH terms:
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Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes