ICE Based Atrial Flutter Ablation Vs Conventional Fluoroscopy/Anatomical Mapping Based Ablation - ICE Flutter Study

Not Applicable

• Conditions: Atrial Flutter
• Interventions: Procedure: 3D electroanatomical mapping alone guided CTI ablation; Procedure: ICE plus 3D electroanatomical mapping guided CTI ablation

• Registration Number: NCT05229848
• Lead Sponsor: Kansas City Heart Rhythm Research Foundation

Brief 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.

Detailed 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 Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-28
• Study Start: 2022-02
• Study First Submitted QC: 2022-02-03
• Last Update Submitted: 2022-02-03
• Study First Posted: 2022-02-08
• Last Update Posted: 2022-02-08
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

All patients undergoing typical CTI dependent AFL who give informed consent for participation in the study will be included.

Exclusion criteria:

• Patients in whom placement of an ICE catheter in the right atrium for adequate atrial visualization is technically not feasible.
• Patients who cannot give an informed consent will be excluded.
• Patients in who vascular access for the 11F sheath is not feasible will be excluded. Those with left iliac vein stenosis or left groin arteriovenous (AV) fistulas or prior left groin access complications will be excluded.
• Patients who on the EP (Electrophysiology) study are found to have a left sided arrhythmia needing transseptal access will be excluded.
• Patients who during EP study are found to have atypical flutter pathways including Left Atrial (LA)/Left sided flutter as above, atypical pathways outside of the CTI, and scar based- reentry pathways.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D electroanatomical mapping alone	3D electroanatomical mapping alone guided CTI ablation	Patients who are diagnosed with typical right sided flutter who are scheduled for an ablation procedure will be enrolled. Informed consent will be obtained from each of them prior to the procedure. Patients will be randomly assigned to undergo either 3D electroanatomical mapping alone vs ICE plus 3D electroanatomical mapping guided CTI ablation. Operators will plan to alternate each case with the use of ICE + 3D mapping and 3D mapping alone with one method followed by the other for randomization. All patients will have the standard access sheaths placed in the right femoral vein.
ICE plus 3D electroanatomical mapping	ICE plus 3D electroanatomical mapping guided CTI ablation	Patients who are diagnosed with typical right sided flutter who are scheduled for an ablation procedure will be enrolled. Informed consent will be obtained from each of them prior to the procedure. Patients will be randomly assigned to undergo either 3D electroanatomical mapping alone vs ICE plus 3D electroanatomical mapping guided CTI ablation. Operators will plan to alternate each case with the use of ICE + 3D mapping and 3D mapping alone with one method followed by the other for randomization. All patients will have the standard access sheaths placed in the right femoral vein. The group randomized to ICE catheter placement will have a left femoral 11F sheath placed in addition.

Primary Outcome Measures

Name	Time	Method
Procedural duration, fluoroscopy time, and RF time assessment	These are all intraprocedural characteristics	To assess the procedural duration, fluoroscopy time, and RF time of patients undergoing CTI dependent flutter ablation using ICE catheter along with 3D anatomical plus fluoroscopy imaging guidance compared to the same parameters in patients undergoing CTI dependent flutter ablation using only 3D anatomical plus fluoroscopy imaging guidance alone.
Post procedural complications	Post-operative Day#0-7	To assess the incidence of post procedural complications such as incidence of perforation, pericardial effusion, cardiac tamponade, and pericarditis.
Procedural success - Number of patients with bidirectional block (entrance block and exit block) at the end of the procedure.	End of procedure marker of success	To assess the procedural success of ablation procedures in terms of achieving bidirectional block.

Trial Locations

Locations (3)

Kansas City Heart Rhythm Institute; 🇺🇸 Overland Park, Kansas, United States

Midwest Heart and Vascular Specialists; 🇺🇸 Overland Park, Kansas, United States

Overland Park Regional Medical Center; 🇺🇸 Overland Park, Kansas, United States