- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04472936
Long-term outcomeS of cavotrIcuspid isthMus-dePendent fLuttEr Ablation: Single vs Double Catheter Procedure
August 29, 2023 updated by: Antonio Berruezo, MD, PhD, Centro Medico Teknon
Long-term outcomeS of cavotrIcuspid isthMus-dePendent fLuttEr Ablation: Randomized Study Comparing Single vs Double Catheter Procedure
Catheter ablation is recommended as first-line therapy for most patients with typical atrial flutter.
The most common approach is to create an ablation line across the cavotricuspid isthmus (CTI).
Traditionally, atrial flutter ablation has been performed with a conventional approach using two catheters, an ablation catheter and a duodecapolar catheter that is placed at the level of the tricuspid annulus to confirm the CTI block.
Recently, a single catheter approach has been described using the behavior of PR interval change during differential pacing over the ablation line to prove CTI block.
This prospective, randomized, multicenter study analyzes the effectivity of a single catheter approach compared with conventional approach in terms of clinical outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Typical atrial flutter is a reentrant rhythm in the right atrium that is constrained anteriorly by the tricuspid annulus and posteriorly by the crista terminalis and eustachian ridge.
Catheter ablation is the first-line therapy for most patients with typical atrial flutter.
The most common approach is to create an ablation line across the CTI, from the tricuspid annulus to the inferior vena cava.
Traditionally, atrial flutter ablation has been performed with a conventional approach using two catheters, an ablation catheter and a duodecapolar catheter that is placed at the level of the tricuspid annulus that allows to evaluate the right atrial activation sequence to confirm the CTI block.
Recently, a single catheter approach has been described using the behavior of PR interval (PRI) change during differential pacing over the ablation line to prove CTI block.
The PRIs is measured for three different pacing site, 5 o'clock (medial to CTI line), 7 o'clock (lateral to CTI line), and 9 o'clock position.
CTI block was assumed when the PRI at 7 o'clock was >80ms longer than that at pacing sites of 5 o'clock and the PRI at 9 o'clock was shorter than the PRI at 7 o'clock.
However, a direct comparison between this approach and the conventional one was not yet performed.
This prospective, randomized, multicenter study analyzes the effectivity of a single catheter approach compared with conventional approach in terms of clinical outcomes.
Our research hypothesis is that a single catheter approach has the possible advantages of being a faster, more efficient and cheaper procedure than the conventional approach.
Moreover, as it only requires a single venous access, the risk of complications is decreased.
Study Type
Interventional
Enrollment (Actual)
253
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Antonio Berruezo, MD, PhD
- Phone Number: (+34) 93 290 62 51
- Email: antonio.berruezo@quironsalud.es
Study Locations
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-
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Barcelona, Spain, 08022
- Centro Medico Teknon
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Cadiz, Spain
- Puerta del Mar University Hospital
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Sevilla, Spain
- Virgen del Rocío University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients admitted at any of the centers to perform a CTI ablation.
- Signed informed consent
Exclusion Criteria:
- Age < 18 years.
- Pregnancy.
- Impossibility to perform CTI ablation.
- Impossibility to measure PRI (complete atrioventricular block).
- Ablation of other cardiac arrhythmias during the same procedure.
- Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A
Double venous femoral access will be obtained.
A duodecapolar catheter placed around tricuspid annulus will be used to prove isthmus block after CTI ablation.
|
Double venous femoral access will be obtained.
A duodecapolar catheter will be positioned in the right atrium around the tricuspid valve annulus (TVA) to record activation sequence around the tricuspid annulus.
An ablation catheter will be positioned using fluoroscopic guidance in the central CTI, 6 o'clock in a left anterior oblique view.
The distal ablation electrode position will then be adjusted toward or away from the TVA, based on the ratio of atrial and ventricular electrogram amplitudes with an optimal ratio of 1:2 or 1:4 at the TVA.
After the ablation catheter is positioned, it will be very slowly withdrawn during ablation toward the inferior vena cava while radiofrequency energy is applied continuously.
CTI block will be evaluated after ablation by determining the right atrial activation sequence during pacing from the low lateral right atrium and coronary sinus ostium.
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Experimental: Group B
Ablation will be performed similar as described in the Group A. After the ablation line is over, PRI on the surface ECG will be used to prove isthmus block after CTI ablation.
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Single venous femoral access will be obtained and the ablation will be performed similar to Group A. After the ablation line is over, we will confirm CTI block using the PRI.
During atrial pacing (10 V, 1.5 ms) at a stable cycle length (range 500-700ms) from the tip of the ablation catheter with a sweep speed of 300mm/s, the ablation catheter will be placed first at 5 o'clock (medial to CTI line), then at 7 o'clock (lateral to CTI line), and finally at 9 o'clock position, and the corresponding PRIs will be measured for each pacing site.
CTI block is assumed when: (i) the PRI at 7 o'clock is >80ms longer than that at pacing sites of 5, and (ii) the PRI at 9 o'clock is shorter than the PRI at 7 o'clock.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical outcomes
Time Frame: 6 months
|
The recurrence rate of typical atrial flutter at 6 months post cavotricuspid isthmus ablation will be evaluated in both groups to determine if the single catheter approach is non-inferior when compared to traditional approach using two catheters.
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficiency in total procedure time
Time Frame: 6 months
|
The total procedure time time will be measured in both groups to determine if the single catheter approach is more efficient procedure.
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6 months
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Efficiency in ablation time
Time Frame: 6 months
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The ablation time will be measured in both groups to determine if the single catheter approach is more efficient procedure.
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6 months
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Efficiency in fluoroscopy time
Time Frame: 6 months
|
The fluoroscopy time will be measured in both groups to determine if the single catheter approach is more efficient procedure.
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6 months
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Complications
Time Frame: 6 months
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We will compare the complication rate of both approaches.
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6 months
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Cost-effectiveness
Time Frame: 6 months
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We will perform a cost-effectiveness analysis.
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Antonio Berruezo, MD, PhD, Centro Medico Teknon
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Feld GK, Fleck RP, Chen PS, Boyce K, Bahnson TD, Stein JB, Calisi CM, Ibarra M. Radiofrequency catheter ablation for the treatment of human type 1 atrial flutter. Identification of a critical zone in the reentrant circuit by endocardial mapping techniques. Circulation. 1992 Oct;86(4):1233-40. doi: 10.1161/01.cir.86.4.1233.
- Cosio FG, Lopez-Gil M, Goicolea A, Arribas F, Barroso JL. Radiofrequency ablation of the inferior vena cava-tricuspid valve isthmus in common atrial flutter. Am J Cardiol. 1993 Mar 15;71(8):705-9. doi: 10.1016/0002-9149(93)91014-9.
- Lesh MD, Van Hare GF, Epstein LM, Fitzpatrick AP, Scheinman MM, Lee RJ, Kwasman MA, Grogin HR, Griffin JC. Radiofrequency catheter ablation of atrial arrhythmias. Results and mechanisms. Circulation. 1994 Mar;89(3):1074-89. doi: 10.1161/01.cir.89.3.1074.
- Page RL, Joglar JA, Caldwell MA, Calkins H, Conti JB, Deal BJ, Estes NA III, Field ME, Goldberger ZD, Hammill SC, Indik JH, Lindsay BD, Olshansky B, Russo AM, Shen WK, Tracy CM, Al-Khatib SM. 2015 ACC/AHA/HRS guideline for the management of adult patients with supraventricular tachycardia: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Heart Rhythm. 2016 Apr;13(4):e136-221. doi: 10.1016/j.hrthm.2015.09.019. Epub 2015 Sep 25. No abstract available.
- Shah DC, Takahashi A, Jais P, Hocini M, Clementy J, Haissaguerre M. Local electrogram-based criteria of cavotricuspid isthmus block. J Cardiovasc Electrophysiol. 1999 May;10(5):662-9. doi: 10.1111/j.1540-8167.1999.tb00243.x.
- Madaffari A, Krisai P, Spies F, Knecht S, Schaer B, Kojic D, Kuhne M, Sticherling C, Osswald S. Ablation of typical atrial flutter guided by the paced PR interval on the surface electrocardiogram: a proof of concept study. Europace. 2019 Nov 1;21(11):1750-1754. doi: 10.1093/europace/euz208.
- Calkins H, Canby R, Weiss R, Taylor G, Wells P, Chinitz L, Milstein S, Compton S, Oleson K, Sherfesee L, Onufer J; 100W Atakr II Investigator Group. Results of catheter ablation of typical atrial flutter. Am J Cardiol. 2004 Aug 15;94(4):437-42. doi: 10.1016/j.amjcard.2004.04.058.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 16, 2020
Primary Completion (Actual)
September 30, 2022
Study Completion (Actual)
November 30, 2022
Study Registration Dates
First Submitted
June 13, 2020
First Submitted That Met QC Criteria
July 12, 2020
First Posted (Actual)
July 16, 2020
Study Record Updates
Last Update Posted (Actual)
August 30, 2023
Last Update Submitted That Met QC Criteria
August 29, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIMPLE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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