Clinical trial NCT05239364: Ablation of Consecutive Atrial Tachycardia
Official title: Ablation of CONseCutive atriaL Tachycardia gUided by Ultra-high-DEnsity Mapping
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Arrhythmia
Heart Diseases
Arrhythmias, Cardiac
Atrial Tachycardia
Keywords: Atrial fibrillation
Atrial tachycardia
Pulmonary vein isolation
Electroanatomical mapping
High density mapping
Lead sponsor: Evangelical Hospital Düsseldorf
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Recurrence of any sustained arrhythmia (>30 sec.)
timeFrame: 1 year
Secondary outcomes:
measure: Inducibility of atrial tachycardia (AT) after ablation of clinical/primary AT (partial success)
timeFrame: Intraprocedural
measure: Predictability of secondary AT by analysis of clinical AT map and voltage map
timeFrame: Intraprocedural
measure: Procedure duration time
timeFrame: Intraprocedural
measure: Fluoroscopy time
timeFrame: intraprocedural
measure: Total radiofrequency application time
timeFrame: intraprocedural
measure: Ablated area (cm2)
timeFrame: intraprocedural
measure: Number of blocked lines
timeFrame: intraprocedural
measure: Area of low voltage in sinus map (cm2)
timeFrame: Intraprocedural
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Evangelic Hospital Düsseldorf
state: North Rhine-Westfalia
city: Hagen
country: Germany
facility: Evangelic Hospital Hagen-Haspe
city: Hamburg
country: Germany
facility: Asklepios St. Georg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig Holstein
Study officials:
affiliation: Evangelic Hospital Düsseldorf
name: Christian Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.