Clinical Trials Logo

Clinical Trial Summary

Intracardiac echocardiography (ICE), has been an essential component of Radiofrequency (RF) ablations for AF given its association with decreased fluoroscopy time and complication rates, and therefore it is logical that this can be applied to CTI ablations for AFL as well. There are however no studies to date that directly focused on the benefits of adding ICE during CTI dependent AFL ablation. Currently it is not required that operators use ICE in every case of AFL ablation. Investigators intended to study the routine use of ICE in such cases and to see if there is a significant benefit in routine use of ICE.


Clinical Trial Description

Atrial flutter (AFL) is a re-entrant tachyarrhythmia that involves the atria that leads to both rapid ventricular rates as well as a loss of effective contractility of the atrial making them vulnerable to formation of thrombi similar to atrial fibrillation (AF). Incidence rates ranges between 5/100,000 in those <50 years old to 587/100,000 in subjects older than 80. AFL often coexists or precedes AF. In a longitudinal study, 56% of patients with lone AFL eventually developed AF. A variety of atrial flutters have been described apart from the classic cavotricuspid isthmus (CTI) dependent flutters. These include left atrial flutters and scar based reentry flutters. Atrial flutter is often a persistent rhythm that requires electrical cardioversion or radiofrequency catheter ablation for termination. While AFL may recur after cardioversion with or without antiarrhythmic therapy, ablation offers a more curative approach for this rather intolerant arrhythmia. 3D electroanatomical mapping in combination with fluoroscopy has been traditionally used in conventional CTI ablation for AFL. However, there are instances when ablation of the CTI is challenging as a result of various factors including a thick Eustachian ridge, presence of a sub-Eustachian pouch, or prominent pectinate muscles. Isthmus anatomy has been shown to affect the parameters of ablation procedure. 3D mapping to overcome difficult anatomy may not be the answer for difficult situations as shown by some operators . These anatomical challenges can not only lengthen procedural times but also lead to increased risk of complications such as perforation, effusion, or cardiac tamponade. Intracardiac echocardiography (ICE), has been an essential component of Radiofrequency (RF) ablations for AF given its association with decreased fluoroscopy time and complication rates, and therefore it is logical that this can be applied to CTI ablations for AFL as well. There are however no studies to date that directly focused on the benefits of adding ICE during CTI dependent AFL ablation. Currently it is not required that operators use ICE in every case of AFL ablation. Investigators intend to study the routine use of ICE in such cases and to see if there is a significant benefit in routine use of ICE. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05229848
Study type Interventional
Source Kansas City Heart Rhythm Research Foundation
Contact Donita Atkins
Phone 8166511969
Email datkins@kchrf.com
Status Not yet recruiting
Phase N/A
Start date February 2022
Completion date April 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Terminated NCT02317029 - Comparison of Oxygen Interventions and Defibrillator Efficiency N/A
Recruiting NCT01563848 - Cryoablation in Patients With Atrial Flutter Phase 2
Completed NCT01229254 - Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter Phase 2
Completed NCT00839657 - Clarification of Optimal Anticoagulation Through Genetics Phase 3
Completed NCT02065388 - Pharmacogenetic Dosing of Warfarin Phase 3
Completed NCT00232232 - Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia Phase 4
Completed NCT04884100 - enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening N/A
Completed NCT05468281 - RAFF5 Proposal: Improve the Quality and Safety of Patients Seen in the Emergency Department for Acute Atrial Fibrillation and Flutter
Completed NCT03627143 - Decreasing Hospital Admissions From the ED for AAFF N/A
Completed NCT02917538 - A Randomized Trial of Contact Force in Atrial Flutter Ablation N/A
Enrolling by invitation NCT05903313 - A Study to Evaluate Accuracy and Validity of the Chang Gung ECG Abnormality Detection Software
Recruiting NCT05755074 - Ablation of Typical Right Atrial Flutter N/A
Recruiting NCT05883631 - RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy. N/A
Recruiting NCT03272620 - Atrial Fibrillation at the Viennese University Emergency Department N/A
Completed NCT02810938 - MIFI Flutter Registry - Ablation of Atrial Flutter With IntellaTip Sensor Technology
Recruiting NCT02591875 - Atrial Flutter Ablation in a Real World Population N/A
Completed NCT02268799 - High Sensitivity Troponin T Levels Following DC Cardioversion for Atrial Fibrillation / Atrial Flutter N/A
Completed NCT01914497 - Dipole Density Mapping of Typical Atrial Flutter N/A
Active, not recruiting NCT01976507 - Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism Phase 4