Ablation of Consecutive Atrial Tachycardia (CONCLUDE)

Evangelical Hospital Düsseldorf

Status: Enrolling

Conditions: Atrial Tachycardia; Arrhythmias, Cardiac; Heart Arrhythmia; Heart Diseases

Treatments: Procedure: Catheter ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05239364

CONCLUDE

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Standard approach

Experimental group

Description:

Patients will receive a standard approach for ablation of atrial tachycardia.

Treatment:

Procedure: Catheter ablation

Minimalized approach

Experimental group

Description:

Patients will receive a minimalized approach for ablation of atrial tachycardia.

Treatment:

Procedure: Catheter ablation