Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias

Tachycardia, Supraventricular Clinical Trial

— COBRA-PATH  

Official title:

Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias: a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04078685
• Other study ID #: NL62017.078.17
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 12, 2018
• Est. completion date: March 20, 2021

Study information

• Verified date: September 2020
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this single-center prospective randomized controlled trial is to assess the superiority of contact-force-(CF)-sensing-based approach compared to conventional (non-CF-sensing) approach in the catheter ablation of PSVTs, and to investigate the safety of open-irrigated, contact-force-sensing ablation catheters (used in a "non-irrigated" mode) in these procedures.

Description:

Rationale:

Multiple studies have demonstrated the importance of adequate catheter-tissue contact in the creation of effective lesions during radiofrequency catheter ablation. The development of contact-force(CF)-sensing catheters have contributed significantly to improve clinical outcomes in atrial fibrillation 3-18. However CF-sensing technology is not used in the ablation of paroxysmal supraventricular tachycardia. Although PSVT ablation with the conventional approach (non-irrigated, non-CF-sensing catheters) is considered a relatively low-risk procedure with fairly high success rate (short-and long-term) 1,2,19, we hypothesize that contact-force sensing can further improve the outcomes of these procedures. Based on the results of studies on atrial fibrillation ablation (mentioned above) we believe that CF-sensing could similarly improve such important parameters as radiofrequency (RF) application number/time, total procedure time, and fluoroscopy time in cases of PSVT ablations, as well. In addition CF-sensing could also further improve acute success/recurrence rates of PSVT ablation, and might also be capable to further diminish complication risk.

Primary Objective:

The primary objective of the present study is to demonstrate the superiority of contact-force-sensing in the ablation of AVNRT and WPW-AVRT as assessed by the improvement in the number and duration of radiofrequency applications compared with the conventional ablation approach.

Secondary Objective:

Secondary objectives of the study are the followings:

• to demonstrate that contact-force-sensing catheters are superior in terms of total procedure duration and fluoroscopy times in the case of AVNRT/WPW-AVRT ablation.

• to show that the use of contact-force sensing catheters is non-inferior to conventional catheters (without contact-force-sensing) in terms of acute/long-term procedural success and procedural safety (major/minor complication rate) of AVNRT/WPW-AVRT ablations.

Study population:

All patients above 18 years without structural heart disease being referred for electrophysiological study and potential treatment with radiofrequency catheter ablation of atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular reentrant tachycardia (AVRT) with manifest (WPW syndrome) or concealed accessory pathways.

Intervention:

One group undergoes manual ablation using standard non-irrigated ablation catheters and the other group undergoes manual ablation with an open-irrigated ablation catheter equipped with CF- sensing (and utilized in a non-irrigated mode during ablation)

Main study parameters/endpoints:

The main study endpoint is the difference in RF application number during the procedures of AVNRT/WPW-AVRT ablation; secondary endpoints are differences in RF application rate, acute success rate, long-term recurrence rate (1 year) major/minor complication rate, and total procedure/fluoroscopy time.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 113
• Est. completion date: March 20, 2021
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Referral for electrophysiology study because of pre-excitation on 12-lead surface ECG and/or documented (or suspected) symptomatic PSVT

• Identification of AVNRT or WPW-AVRT (with manifest or concealed accessory pathway) during standard EP study

• Verbal consent to continue with ablation therapy

• Informed written consent to be included in the study

Exclusion Criteria:

• evidence of structural heart disease and/or myocardial ischemia

• pregnancy (and lack of exclusion of potential pregnancy)

• age below 18 years

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Paroxysmal
• Tachycardia, Supraventricular
• Tachycardia; Paroxysmal, Supraventricular

Intervention

Procedure:
• Standard catheter ablation
Radiofrequency catheter ablation using a standard ablation catheters: not equipped with contact-force sensing
• Contact Force-sensing-based catheter ablation
Radiofrequency catheter ablation using a Contact-Force-sensing ablation catheter

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (8)

Gerstenfeld EP. Contact force-sensing catheters: evolution or revolution in catheter ablation technology? Circ Arrhythm Electrophysiol. 2014 Feb;7(1):5-6. doi: 10.1161/CIRCEP.114.001424. — View Citation

Kautzner J, Neuzil P, Lambert H, Peichl P, Petru J, Cihak R, Skoda J, Wichterle D, Wissner E, Yulzari A, Kuck KH. EFFICAS II: optimization of catheter contact force improves outcome of pulmonary vein isolation for paroxysmal atrial fibrillation. Europace. 2015 Aug;17(8):1229-35. doi: 10.1093/europace/euv057. Epub 2015 Jun 3. — View Citation

Kimura M, Sasaki S, Owada S, Horiuchi D, Sasaki K, Itoh T, Ishida Y, Kinjo T, Tomita H, Okumura K. Comparison of lesion formation between contact force-guided and non-guided circumferential pulmonary vein isolation: a prospective, randomized study. Heart Rhythm. 2014 Jun;11(6):984-91. doi: 10.1016/j.hrthm.2014.03.019. Epub 2014 Mar 18. — View Citation

Kuck KH, Reddy VY, Schmidt B, Natale A, Neuzil P, Saoudi N, Kautzner J, Herrera C, Hindricks G, Jaïs P, Nakagawa H, Lambert H, Shah DC. A novel radiofrequency ablation catheter using contact force sensing: Toccata study. Heart Rhythm. 2012 Jan;9(1):18-23. doi: 10.1016/j.hrthm.2011.08.021. Epub 2011 Aug 26. — View Citation

Martinek M, Lemes C, Sigmund E, Derndorfer M, Aichinger J, Winter S, Nesser HJ, Pürerfellner H. Clinical impact of an open-irrigated radiofrequency catheter with direct force measurement on atrial fibrillation ablation. Pacing Clin Electrophysiol. 2012 Nov;35(11):1312-8. doi: 10.1111/j.1540-8159.2012.03503.x. Epub 2012 Sep 4. — View Citation

Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072. — View Citation

Shurrab M, Di Biase L, Briceno DF, Kaoutskaia A, Haj-Yahia S, Newman D, Lashevsky I, Nakagawa H, Crystal E. Impact of Contact Force Technology on Atrial Fibrillation Ablation: A Meta-Analysis. J Am Heart Assoc. 2015 Sep 21;4(9):e002476. doi: 10.1161/JAHA.115.002476. Review. — View Citation

Ullah W, Hunter RJ, Haldar S, McLean A, Dhinoja M, Sporton S, Earley MJ, Lorgat F, Wong T, Schilling RJ. Comparison of robotic and manual persistent AF ablation using catheter contact force sensing: an international multicenter registry study. Pacing Clin Electrophysiol. 2014 Nov;37(11):1427-35. doi: 10.1111/pace.12501. Epub 2014 Sep 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of radiofrequency applications	The number of radiofrequency applications during the ablation procedures of AVNRT and WPW-AVRT	From the beginning till the end of the ablation procedure
Secondary	Overall duration of radiofrequency applications	total of time spend from the beginning till the end of the ablation procedure	From the beginning till the end of the ablation procedure
Secondary	Long-term procedural success	Free from recurrence of pre-excitation or the same clinical type of paroxysmal supraventricular tachycardia (AVNRT or AVRT)	At 12 months
Secondary	Acute procedural success/failure	non-inducibility of clinical arrhythmia verified at the end of the standard EP study	at the end of the ablation procedure
Secondary	Fluoroscopy time	total time for fluoroscopy time	From the beginning till the end of the ablation procedure
Secondary	Total duration of procedure	total time for duration of the procedure	From the beginning till the end of the ablation procedure
Secondary	(Serious) Adverse Events	all reported SAEs	Till 12 months
Secondary	Time to recurrence of AVNRT/WPW-AVRT	if recurrence of AVNRT/WPW-AVRT, time to recurrence	up till 12 months