Ablation of Consecutive Atrial Tachycardia (CONCLUDE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Arrhythmias, Cardiac; Atrial Tachycardia; Heart Arrhythmia
• Intervention / Treatment: Procedure: Catheter ablation

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hagen, Germany
    • Recruiting
    • Evangelic Hospital Hagen-Haspe
    • Contact: Harilaos Bogossian, MD
  • Hamburg, Germany
    • Recruiting
    • Asklepios St. Georg
    • Contact: Stephan Willems, MD
  • Kiel, Germany
    • Recruiting
    • Universitatsklinikum Schleswig Holstein
  • North Rhine-Westfalia
    • Düsseldorf, North Rhine-Westfalia, Germany, 40217
      • Recruiting
      • Evangelic Hospital Düsseldorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Standard approach; Patients will receive a standard approach for ablation of atrial tachycardia.	Procedure: Catheter ablation; Catheter-based ablation of arrhythmias using radiofrequency.
EXPERIMENTAL: Minimalized approach; Patients will receive a minimalized approach for ablation of atrial tachycardia.	Procedure: Catheter ablation; Catheter-based ablation of arrhythmias using radiofrequency.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrence of any sustained arrhythmia (>30 sec.)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inducibility of atrial tachycardia (AT) after ablation of clinical/primary AT (partial success)	Categorical variable (yes/no)	Intraprocedural
Predictability of secondary AT by analysis of clinical AT map and voltage map		Intraprocedural
Procedure duration time		Intraprocedural
Fluoroscopy time		intraprocedural
Total radiofrequency application time		intraprocedural
Ablated area (cm2)		intraprocedural
Number of blocked lines		intraprocedural
Area of low voltage in sinus map (cm2)		Intraprocedural

Collaborators and Investigators

• Sponsor: Evangelical Hospital Düsseldorf
• Investigators: Principal Investigator: Christian Meyer, MD, Evangelic Hospital Düsseldorf

Publications and helpful links

General Publications

• 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.
• 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, Jais P, Haissaguerre 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.
• 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. No abstract available.
• 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, Massoulie 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 22, 2020
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (ACTUAL): February 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Pulmonary vein isolation; Electroanatomical mapping; Atrial tachycardia; High density mapping
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Diseases; Arrhythmias, Cardiac; Tachycardia
• Other Study ID Numbers: CONCLUDE

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