NCT05229848

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

December 28, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

February 8, 2022

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

December 28, 2021

Last Update Submit

February 3, 2022

Conditions

Atrial Flutter

Keywords

Atrial FlutterAblationIntra-cardiac echocardiogram (ICE)

Outcome Measures

Primary Outcomes (3)

  • Procedural duration, fluoroscopy time, and RF time assessment

    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.

    These are all intraprocedural characteristics

  • Post procedural complications

    To assess the incidence of post procedural complications such as incidence of perforation, pericardial effusion, cardiac tamponade, and pericarditis.

    Post-operative Day#0-7

  • Procedural success - Number of patients with bidirectional block (entrance block and exit block) at the end of the procedure.

    To assess the procedural success of ablation procedures in terms of achieving bidirectional block.

    End of procedure marker of success

Study Arms (2)

3D electroanatomical mapping alone

ACTIVE COMPARATOR

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.

Procedure: 3D electroanatomical mapping alone guided CTI ablation

ICE plus 3D electroanatomical mapping

EXPERIMENTAL

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.

Procedure: ICE plus 3D electroanatomical mapping guided CTI ablation

Interventions

3D electroanatomical mapping alone guided CTI ablationPROCEDURE

3D electroanatomical mapping in combination with fluoroscopy has been traditionally used in conventional CTI ablation for AFL.

3D electroanatomical mapping alone
ICE plus 3D electroanatomical mapping guided CTI ablationPROCEDURE

ICE imaging catheter is typically introduced through an 11-F hemostatic sheath and positioned under fluoroscopic guidance in the right atrium. After catheter coupling to the imaging platform, imaging frequency is optimized by the operator using adjunctive gain, depth, and focal length controls to define anatomic structures and minimize noise. Imaging is performed at different levels in the right atrium, if needed. Imaging targets included the right atrium, coronary sinus orifice, fossa ovalis, interatrial septum (IAS), tricuspid valve, left atrium, left atrial appendage, orifice of all pulmonary veins, mitral valve, papillary muscles, aortic and pulmonary valve leaflets, right ventricle, RVOT, pericardial space, esophagus, aorta and adjoining left ventricular and right ventricular myocardium.

ICE plus 3D electroanatomical mapping

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Midwest Heart and Vascular Specialists

Overland Park, Kansas, 66211, United States

Location

Overland Park Regional Medical Center

Overland Park, Kansas, 66215, United States

Location

Related Publications (8)

  • Granada J, Uribe W, Chyou PH, Maassen K, Vierkant R, Smith PN, Hayes J, Eaker E, Vidaillet H. Incidence and predictors of atrial flutter in the general population. J Am Coll Cardiol. 2000 Dec;36(7):2242-6. doi: 10.1016/s0735-1097(00)00982-7.

    PMID: 11127467BACKGROUND

  • Halligan SC, Gersh BJ, Brown RD Jr, Rosales AG, Munger TM, Shen WK, Hammill SC, Friedman PA. The natural history of lone atrial flutter. Ann Intern Med. 2004 Feb 17;140(4):265-8. doi: 10.7326/0003-4819-140-4-200402170-00008.

    PMID: 14970149BACKGROUND

  • Bun SS, Latcu DG, Marchlinski F, Saoudi N. Atrial flutter: more than just one of a kind. Eur Heart J. 2015 Sep 14;36(35):2356-63. doi: 10.1093/eurheartj/ehv118. Epub 2015 Apr 2.

    PMID: 25838435BACKGROUND

  • January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.

    PMID: 24685669BACKGROUND

  • Sehar N, Mears J, Bisco S, Patel S, Lachman N, Asirvatham SJ. Anatomic guidance for ablation: atrial flutter, fibrillation, and outflow tract ventricular tachycardia. Indian Pacing Electrophysiol J. 2010 Aug 10;10(8):339-56.

    PMID: 20811537BACKGROUND

  • Da Costa A, Faure E, Thevenin J, Messier M, Bernard S, Abdel K, Robin C, Romeyer C, Isaaz K. Effect of isthmus anatomy and ablation catheter on radiofrequency catheter ablation of the cavotricuspid isthmus. Circulation. 2004 Aug 31;110(9):1030-5. doi: 10.1161/01.CIR.0000139845.40818.75. Epub 2004 Aug 23.

    PMID: 15326078BACKGROUND

  • Schernthaner C, Haidinger B, Brandt MC, Kraus J, Danmayr F, Hoppe UC, Strohmer B. The influence of cavotricuspid isthmus length on total radiofrequency energy to cure right atrial flutter. Kardiol Pol. 2016;74(3):237-43. doi: 10.5603/KP.a2015.0159. Epub 2015 Aug 25.

    PMID: 26305365BACKGROUND

  • Cohen TJ, Ibrahim B, Lazar J, Rosen J, Klein J. Utility of intracardiac echocardiography (ICE) in electrophysiology: ICEing the CAKE (catheter ablation knowledge enhancement). J Invasive Cardiol. 1999 Jun;11(6):364-8.

    PMID: 10745552BACKGROUND

MeSH Terms

Conditions

Atrial Flutter

Interventions

Ice

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

WaterHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsEnvironmentEcological and Environmental PhenomenaBiological PhenomenaWeatherMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Dhanunjaya Lakkireddy, MD

    Kansas City Heart Rhythm Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

8166511969datkins@kchrf.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Total 60 patients will be studied. St.Jude View Flex ICE catheter and Siemens AcuNav ICE catheter are used routinely for all left sided ablation procedures which require transeptal puncture. ICE imaging catheter is typically introduced through an 11-F hemostatic sheath and positioned under fluoroscopic guidance in right atrium. After catheter coupling to the imaging platform, imaging frequency is optimized using adjunctive gain, depth, and focal length controls to define anatomic structures and minimize noise.Imaging is performed at different levels in right atrium, if needed. Imaging targets included right atrium, coronary sinus orifice, fossa ovalis, interatrial septum(IAS), tricuspid valve,left atrium, left atrial appendage, orifice of all pulmonary veins,mitral valve, papillary muscles, aortic and pulmonary valve leaflets, right ventricle, right ventricular outflow tract(RVOT),pericardial space,esophagus,aorta and adjoining left ventricular and right ventricular myocardium.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2021

First Posted

February 8, 2022

Study Start

February 1, 2022

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

February 8, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(3)