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NCT Number: NCT05239364

Ablation of Consecutive Atrial Tachycardia

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.

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Key information

Conditions

Heart Arrhythmia Arrhythmias, Cardiac Atrial Fibrillation Atrial Tachycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asklepios St. Georg, Hamburg, Free and Hanseatic City of Hamburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheter ablation

Procedure

Catheter-based ablation of arrhythmias using radiofrequency.

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Inducibility of atrial tachycardia (AT) after ablation of clinical/primary AT (partial success)

    Time frame: Intraprocedural

    Categorical variable (yes/no)

  2. Predictability of secondary AT by analysis of clinical AT map and voltage map

    Time frame: Intraprocedural

  3. Procedure duration time

    Time frame: Intraprocedural

  4. Fluoroscopy time

    Time frame: intraprocedural

  5. Total radiofrequency application time

    Time frame: intraprocedural

  6. Ablated area (cm2)

    Time frame: intraprocedural

  7. Number of blocked lines

    Time frame: intraprocedural

  8. Area of low voltage in sinus map (cm2)

    Time frame: Intraprocedural

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Meyer, MD

CONTACT

[email protected]

00492119191855

Sponsors and collaborators

Lead sponsor

Evangelical Hospital Düsseldorf

Other

Registry information

Official study title

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

Acronym: CONCLUDE

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Feb 14, 2022
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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