Long-term outcomeS of cavotrIcuspid isthMus-dePendent fLuttEr Ablation: Single vs Double Catheter Procedure

NCT04472936 | Completed

• 1 other identifier: SIMPLE
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Atrial Flutter

Keywords

Atrial flutter; Catheter ablation; Single catheter approach

Outcome Measures

Primary Outcomes (1)

• Clinical outcomes

  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.

  6 months

Secondary Outcomes (5)

• Efficiency in total procedure time

  6 months

• Efficiency in ablation time

  6 months

• Efficiency in fluoroscopy time

  6 months

• Complications

  6 months

• Cost-effectiveness

  6 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

Double venous femoral access will be obtained. A duodecapolar catheter placed around tricuspid annulus will be used to prove isthmus block after CTI ablation.

Procedure: Traditional approach

Group B

EXPERIMENTAL

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.

Procedure: Single catheter approach

Interventions

Single catheter approach PROCEDURE

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.

Group B

Traditional approach PROCEDURE

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.

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted at any of the centers to perform a CTI ablation.
• Signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Medico Teknon: lead

Study Sites (3)

Centro Medico Teknon

Barcelona, 08022, Spain

Location

Puerta del Mar University Hospital

Cadiz, Spain

Location

Virgen del Rocio University Hospital

Seville, Spain

Location

Related Publications (7)

• 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.

  PMID: 1394929 BACKGROUND

• 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.

  PMID: 8447269 BACKGROUND

• 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.

  PMID: 8124793 BACKGROUND

• 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.

  PMID: 26409100 BACKGROUND

• 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.

  PMID: 10355922 BACKGROUND

• 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.

  PMID: 31384937 BACKGROUND

• 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.

  PMID: 15325925 BACKGROUND

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Berruezo, MD, PhD

  Centro Medico Teknon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator of the Heart Institute

Study Record Dates

• First Submitted: June 13, 2020
• First Posted: July 16, 2020
• Study Start: July 16, 2020
• Primary Completion: September 30, 2022
• Study Completion: November 30, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)