Recruiting NCT05239364
Ablation of Consecutive Atrial Tachycardia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Catheter ablation.
- Who it may be relevant to
- Registry conditions: Heart Arrhythmia, Heart Diseases, Arrhythmias, Cardiac, Atrial Tachycardia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ablation of CONseCutive atriaL Tachycardia gUided by Ultra-high-DEnsity Mapping
Overview
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.
Interventions
- Procedure Catheter ablation
Catheter-based ablation of arrhythmias using radiofrequency.
Primary outcome measures
- Recurrence of any sustained arrhythmia (>30 sec.) [Time frame: 1 year]
Secondary outcome measures (8)
- Inducibility of atrial tachycardia (AT) after ablation of clinical/primary AT (partial success) [Time frame: Intraprocedural]
- Predictability of secondary AT by analysis of clinical AT map and voltage map [Time frame: Intraprocedural]
- Procedure duration time [Time frame: Intraprocedural]
- Fluoroscopy time [Time frame: intraprocedural]
- Total radiofrequency application time [Time frame: intraprocedural]
- Ablated area (cm2) [Time frame: intraprocedural]
- Number of blocked lines [Time frame: intraprocedural]
- Area of low voltage in sinus map (cm2) [Time frame: Intraprocedural]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 6 centers
- Asklepios St. Georg — Hamburg
- Evangelic Hospital Düsseldorf — Düsseldorf
- Vivantes Klinikum Am Urban Berlin — Berlin
- Evangelic Hospital Hagen-Haspe — Hagen
- Städtisches Klinikum Karlsruhe — Karlsruhe
- Universitätsklinikum Schleswig Holstein — Kiel
Publications
- 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 He PMID 41435855
- 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 32748442
- 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.2 PMID 32703564
- 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 31400216
- 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 PMID 31004777
Identifiers
NCT: NCT05239364 · CONCLUDE