Ablation of Consecutive Atrial Tachycardia

Not Applicable

Recruiting

• Conditions: Atrial Tachycardia; Heart Arrhythmia; Heart Diseases; Arrhythmias, Cardiac
• Interventions: Procedure: Catheter ablation

• Registration Number: NCT05239364
• Lead Sponsor: Evangelical Hospital Düsseldorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-22
• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-14
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-10
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard approach	Catheter ablation	Patients will receive a standard approach for ablation of atrial tachycardia.
Minimalized approach	Catheter ablation	Patients will receive a minimalized approach for ablation of atrial tachycardia.

Primary Outcome Measures

Name	Time	Method
Recurrence of any sustained arrhythmia (>30 sec.)	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Evangelic Hospital Hagen-Haspe; 🇩🇪 Hagen, Germany

Asklepios St. Georg; 🇩🇪 Hamburg, Germany

Universitätsklinikum Schleswig Holstein; 🇩🇪 Kiel, Germany

Evangelic Hospital Düsseldorf; 🇩🇪 Düsseldorf, North Rhine-Westfalia, Germany