NCT05239364

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Dec 2020Jun 2027

Study Start

First participant enrolled

December 22, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

6.4 years

First QC Date

January 10, 2022

Last Update Submit

April 27, 2026

Conditions

Heart ArrhythmiaHeart DiseasesArrhythmias, CardiacAtrial Tachycardia

Keywords

Atrial fibrillationAtrial tachycardiaPulmonary vein isolationElectroanatomical mappingHigh density mapping

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (8)

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

    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

  • +3 more secondary outcomes

Study Arms (2)

Standard approach

EXPERIMENTAL

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

Procedure: Catheter ablation

Minimalized approach

EXPERIMENTAL

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

Procedure: Catheter ablation

Interventions

Catheter ablationPROCEDURE

Catheter-based ablation of arrhythmias using radiofrequency.

Minimalized approachStandard approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Asklepios St. Georg

Hamburg, Free and Hanseatic City of Hamburg, Germany

RECRUITING

Evangelic Hospital Düsseldorf

Düsseldorf, North Rhine-Westfalia, 40217, Germany

RECRUITING

Vivantes Klinikum Am Urban Berlin

Berlin, Germany

RECRUITING

Evangelic Hospital Hagen-Haspe

Hagen, Germany

RECRUITING

Städtisches Klinikum Karlsruhe

Karlsruhe, Germany

RECRUITING

Universitätsklinikum Schleswig Holstein

Kiel, Germany

RECRUITING

Related Publications (5)

  • Meyer C, Kahle AK, Dagres N, Derval N, Dewland TA, Drago F, Eckardt L, Frontera A, Gerstenfeld EP, Hardy C, Jais P, Kalman J, Kistler PM, Martin C, Purerfellner H, Takigawa M, Wong T, Zeppenfeld K. Management of patients with atrial tachycardia: a clinical consensus statement of the European Heart Rhythm Association (EHRA) of the ESC, endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), and the Association for European Paediatric and Congenital Cardiology (AEPC). Europace. 2025 Dec 1;27(12):euaf324. doi: 10.1093/europace/euaf324.

    PMID: 41435855BACKGROUND

  • 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.

    PMID: 32748442BACKGROUND

  • 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.

    PMID: 32703564BACKGROUND

  • 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.

    PMID: 31400216BACKGROUND

  • 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.

    PMID: 31004777BACKGROUND

MeSH Terms

Conditions

Arrhythmias, CardiacHeart DiseasesAtrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Christian Meyer, MD

    Evangelic Hospital Düsseldorf

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Meyer, MD

CONTACT

00492119191855christian.meyer@evk-duesseldorf.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Christian Meyer

Study Record Dates

First Submitted

January 10, 2022

First Posted

February 14, 2022

Study Start

December 22, 2020

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(6)