Ablation of Consecutive Atrial Tachycardia

NCT ID: NCT05239364

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-22
• Study Completion Date: 2024-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard approach

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

Group Type: EXPERIMENTAL

Catheter ablation

Intervention Type: PROCEDURE

Catheter-based ablation of arrhythmias using radiofrequency.

Minimalized approach

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

Group Type: EXPERIMENTAL

Catheter ablation

Intervention Type: PROCEDURE

Catheter-based ablation of arrhythmias using radiofrequency.

Interventions

Catheter ablation

Catheter-based ablation of arrhythmias using radiofrequency.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evangelical Hospital Düsseldorf

OTHER

Sponsor Role: lead

Responsible Party

Christian Meyer

Prof. Dr. Christian Meyer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

Evangelic Hospital Düsseldorf

Locations

Evangelic Hospital Düsseldorf

Düsseldorf, North Rhine-Westfalia, Germany

Site Status: RECRUITING

Evangelic Hospital Hagen-Haspe

Hagen, , Germany

Site Status: RECRUITING

Asklepios St. Georg

Hamburg, , Germany

Site Status: RECRUITING

Universitätsklinikum Schleswig Holstein

Kiel, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Christian Meyer, MD

Role: CONTACT

christian.meyer@evk-duesseldorf.de

00492119191855

Facility Contacts

Christian Meyer, MD

Role: primary

christian.meyer@evk-duesseldorf.de

00492119191855

Katharina Scherschel, PhD

Role: backup

katharina.scherschel@evk-duesseldorf.de

Harilaos Bogossian, MD

Role: primary

Stephan Willems, MD

Role: primary

Evgeny Lyan, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 32748442 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32703564 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31400216 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31004777 (View on PubMed)

Other Identifiers

CONCLUDE

Identifier Type: -

Identifier Source: org_study_id