CONCLUDE: Ablation of Consecutive Atrial Tachycardia

Sponsor

Evangelical Hospital Düsseldorf (Other)

Overall Status

Recruiting

CT.gov ID

NCT05239364

Collaborator

(none)

100

Enrollment

Locations

Arms

47.3

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Arrhythmia Heart Diseases Arrhythmias, Cardiac Atrial Tachycardia	Procedure: Catheter ablation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 22, 2020

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Recurrence of any sustained arrhythmia (>30 sec.) [1 year]

Secondary Outcome Measures

Inducibility of atrial tachycardia (AT) after ablation of clinical/primary AT (partial success) [Intraprocedural]
Categorical variable (yes/no)
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Evangelic Hospital Düsseldorf	Düsseldorf	North Rhine-Westfalia	Germany	40217
2	Universitätsklinikum Schleswig Holstein	Kiel	Schleswig Holstein	Germany	24105