Atrial FlutterNCT05229848
ICE Based Atrial Flutter Ablation Vs Conventional Fluoroscopy/Anatomical Mapping Based Ablation - ICE Flutter Study
A study testing 3D electroanatomical mapping alone guided CTI ablation and ICE plus 3D electroanatomical mapping guided CTI ablation in people with Atrial Flutter, run by Kansas City Heart Rhythm Research Foundation at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Flutter
- What is being tested?
- 3D electroanatomical mapping alone guided CTI ablation and ICE plus 3D electroanatomical mapping guided CTI ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2022to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing typical CTI dependent AFL who give informed consent for participation in the study will be included.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
Donita Atkins, 816-651-1969, Donita.Atkins@kchrf.com
Midwest Heart and Vascular Specialists
Overland Park, Kansas, 66211
Donita Atkins, 816-651-1969, datkins@kchrf.com
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
Donita Atkins, 816-651-1969, datkins@kchrf.com
About this study
Official title: Prospective Comparison of ICE Based Atrial Flutter Ablation Vs Conventional Fluoroscopy/Anatomical Mapping Based Ablation
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.
Read the 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.
- Conditions
- Atrial Flutter
- Being tested
- 3D electroanatomical mapping alone guided CTI ablation, ICE plus 3D electroanatomical mapping guided CTI ablation
- Keywords
- Atrial Flutter, Ablation, Intra-cardiac echocardiogram (ICE)
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D electroanatomical mapping alone guided CTI ablationProcedure or surgery
3D electroanatomical mapping in combination with fluoroscopy has been traditionally used in conventional CTI ablation for AFL.
ICE plus 3D electroanatomical mapping guided CTI ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: ICE plus 3D electroanatomical mapping guided CTI ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: End of procedure marker of success
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study startFeb 2022 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Atrial FlutterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dhanunjaya Lakkireddy, MD, Principal investigator, Kansas City Heart Rhythm Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229848
- Sponsor's protocol ID
- KCHRF-ICE Flutter-0010
- Status last verified
- Dec 2021
- First submitted
- 28 Dec 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11127467Halligan 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.
PubMed 14970149Bun 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.
PubMed 25838435January 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.
PubMed 24685669Sehar 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.
PubMed 20811537Da 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.
PubMed 15326078Schernthaner 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.
PubMed 26305365Cohen 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.
PubMed 10745552
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of ICE Based Atrial Flutter Ablation Vs Conventional Fluoroscopy/Anatomical Mapping Based Ablation
- ClinicalTrials.gov ID
- NCT05229848
- Acronym / sponsor ID
- KCHRF-ICE Flutter-0010
- Conditions
- Atrial Flutter
- Keywords
- Atrial Flutter, Ablation, Intra-cardiac echocardiogram (ICE)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kansas City Heart Rhythm Research FoundationUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 3D electroanatomical mapping alone | Active comparator | Procedure: 3D electroanatomical mapping alone guided CTI ablationPatients 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 | Experimental | Procedure: ICE plus 3D electroanatomical mapping guided CTI ablationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing typical CTI dependent AFL who give informed consent for participation in the study will be included.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D electroanatomical mapping alone guided CTI ablation3D electroanatomical mapping in combination with fluoroscopy has been traditionally used in conventional CTI ablation for AFL. | Procedure or surgery | 3D electroanatomical mapping alone |
| ICE plus 3D electroanatomical mapping guided CTI ablationICE 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. | Procedure or surgery | ICE plus 3D electroanatomical mapping |
Primary outcome
Procedural duration, fluoroscopy time, and RF time assessment
Time frame: 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
Time frame: 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.
Time frame: End of procedure marker of success
To assess the procedural success of ablation procedures in terms of achieving bidirectional block.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Background: PubMed 11127467Granada 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.
- Background: PubMed 14970149Halligan 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.
- Background: PubMed 25838435Bun 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.
- Background: PubMed 24685669January 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.
- Background: PubMed 20811537Sehar 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.
- Background: PubMed 15326078Da 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.
- Background: PubMed 26305365Schernthaner 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.
- Background: PubMed 10745552Cohen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhanunjaya Lakkireddy, MD principal investigator
Kansas City Heart Rhythm Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D electroanatomical mapping alone guided CTI ablation and ICE plus 3D electroanatomical mapping guided CTI ablation in people with Atrial Flutter, run by Kansas City Heart Rhythm Research Foundation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donita Atkins (8166511969, datkins@kchrf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural duration, fluoroscopy time, and RF time assessment (time frame: These are all intraprocedural characteristics). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05229848, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.