Ablation of Consecutive Atrial Tachycardia

Heart Diseases Clinical Trial

— CONCLUDE  

Official title:

Ablation of CONseCutive atriaL Tachycardia gUided by Ultra-high-DEnsity Mapping

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05239364
• Other study ID #: CONCLUDE
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2020
• Est. completion date: December 2024

Study information

• Verified date: November 2022
• Source: Evangelical Hospital Düsseldorf
• Contact: Christian Meyer, MD
• Phone: 00492119191855
• Email: christian.meyer[@]evk-duesseldorf.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ablation of consecutive atrial tachycardia (AT) after ablation of atrial fibrillation (AF) or cardiac surgery can be challenging due to complex substrate and AT mechanisms. A substantial portion of patients is known to show various tachycardias and recurrences occur in a noticeable number of cases. With the availability of novel ultra-high-density mapping techniques characterization and understanding of AT mechanisms and underlying substrate can be improved. Aim of this prospective, multi-center, randomized study is to compare a standard AT ablation approach versus minimalized ablation of the clinical AT in regards to arrhythmia free survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive AT subsequent to prior AF ablation procedure or cardiac surgery
• Surface ECG-documentation of AT as primary clinical arrhythmia
• ECG indicating stable, map-able AT (stable activation sequence, and CL stability) with cycle length = 200ms

Exclusion Criteria:

• < 18 years
• No previous atrial fibrillation ablation procedure or cardiac surgery
• Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment
• History of hemorrhagic diathesis or other coagulopathies
• Contraindications for oral anticoagulation
• Hyper- or hypothyroidism
• Has any condition that would make participation not be in the best interest of the subject

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Tachycardia
• Heart Arrhythmia
• Heart Diseases
• Tachycardia

Intervention

Procedure:
• Catheter ablation
Catheter-based ablation of arrhythmias using radiofrequency.

Locations

Country	Name	City	State
Germany	Evangelic Hospital Düsseldorf	Düsseldorf	North Rhine-Westfalia
Germany	Evangelic Hospital Hagen-Haspe	Hagen
Germany	Asklepios St. Georg	Hamburg
Germany	Universitätsklinikum Schleswig Holstein	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Evangelical Hospital Düsseldorf

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Derval N, Takigawa M, Frontera A, Mahida S, Konstantinos V, Denis A, Duchateau J, Pillois X, Yamashita S, Berte B, Thompson N, Hooks D, Pambrun T, Sacher F, Hocini M, Bordachar P, Jaïs P, Haïssaguerre M. Characterization of Complex Atrial Tachycardia in Patients With Previous Atrial Interventions Using High-Resolution Mapping. JACC Clin Electrophysiol. 2020 Jul;6(7):815-826. doi: 10.1016/j.jacep.2020.03.004. Epub 2020 May 27. — View Citation

Jungen C, Akbulak R, Kahle AK, Eickholt C, Schaeffer B, Scherschel K, Dinshaw L, Muenkler P, Schleberger R, Nies M, Gunawardene MA, Klatt N, Hartmann J, Merbold L, Jularic M, Willems S, Meyer C. Outcome after tailored catheter ablation of atrial tachycardia using ultra-high-density mapping. J Cardiovasc Electrophysiol. 2020 Oct;31(10):2645-2652. doi: 10.1111/jce.14703. Epub 2020 Aug 11. — View Citation

Meyer C. High-density mapping-based ablation strategies of cardiac rhythm disorders: the RHYTHMIA™ experience at new horizons. Europace. 2019 Aug 1;21(Supplement_3):iii7-iii10. doi: 10.1093/europace/euz154. — View Citation

Takigawa M, Martin CA, Derval N, Denis A, Vlachos K, Kitamura T, Frontera A, Martin R, Cheniti G, Lam A, Bourier F, Thompson N, Wolf M, Massoulié G, Escande W, Andre C, Zeng LJ, Nakatani Y, Roux JR, Duchateau J, Pambrun T, Sacher F, Cochet H, Hocini M, Haissaguerre M, Jais P. Insights from atrial surface activation throughout atrial tachycardia cycle length: A new mapping tool. Heart Rhythm. 2019 Nov;16(11):1652-1660. doi: 10.1016/j.hrthm.2019.04.029. Epub 2019 Apr 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of any sustained arrhythmia (>30 sec.)		1 year
Secondary	Inducibility of atrial tachycardia (AT) after ablation of clinical/primary AT (partial success)	Categorical variable (yes/no)	Intraprocedural
Secondary	Predictability of secondary AT by analysis of clinical AT map and voltage map		Intraprocedural
Secondary	Procedure duration time		Intraprocedural
Secondary	Fluoroscopy time		intraprocedural
Secondary	Total radiofrequency application time		intraprocedural
Secondary	Ablated area (cm2)		intraprocedural
Secondary	Number of blocked lines		intraprocedural
Secondary	Area of low voltage in sinus map (cm2)		Intraprocedural