Ablation of Consecutive Atrial Tachycardia (CONCLUDE)
Primary Purpose
Heart Arrhythmia, Heart Diseases, Arrhythmias, Cardiac
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Catheter ablation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Arrhythmia focused on measuring Atrial fibrillation, Atrial tachycardia, Pulmonary vein isolation, Electroanatomical mapping, High density mapping
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
Sites / Locations
- Evangelic Hospital DüsseldorfRecruiting
- Evangelic Hospital Hagen-HaspeRecruiting
- Asklepios St. GeorgRecruiting
- Universitätsklinikum Schleswig HolsteinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Standard approach
Minimalized approach
Arm Description
Patients will receive a standard approach for ablation of atrial tachycardia.
Patients will receive a minimalized approach for ablation of atrial tachycardia.
Outcomes
Primary Outcome Measures
Recurrence of any sustained arrhythmia (>30 sec.)
Secondary Outcome Measures
Inducibility of atrial tachycardia (AT) after ablation of clinical/primary AT (partial success)
Categorical variable (yes/no)
Predictability of secondary AT by analysis of clinical AT map and voltage map
Procedure duration time
Fluoroscopy time
Total radiofrequency application time
Ablated area (cm2)
Number of blocked lines
Area of low voltage in sinus map (cm2)
Full Information
NCT ID
NCT05239364
First Posted
January 10, 2022
Last Updated
November 9, 2022
Sponsor
Evangelical Hospital Düsseldorf
1. Study Identification
Unique Protocol Identification Number
NCT05239364
Brief Title
Ablation of Consecutive Atrial Tachycardia
Acronym
CONCLUDE
Official Title
Ablation of CONseCutive atriaL Tachycardia gUided by Ultra-high-DEnsity Mapping
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Evangelical Hospital Düsseldorf
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Arrhythmia, Heart Diseases, Arrhythmias, Cardiac, Atrial Tachycardia
Keywords
Atrial fibrillation, Atrial tachycardia, Pulmonary vein isolation, Electroanatomical mapping, High density mapping
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard approach
Arm Type
Experimental
Arm Description
Patients will receive a standard approach for ablation of atrial tachycardia.
Arm Title
Minimalized approach
Arm Type
Experimental
Arm Description
Patients will receive a minimalized approach for ablation of atrial tachycardia.
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation
Intervention Description
Catheter-based ablation of arrhythmias using radiofrequency.
Primary Outcome Measure Information:
Title
Recurrence of any sustained arrhythmia (>30 sec.)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Inducibility of atrial tachycardia (AT) after ablation of clinical/primary AT (partial success)
Description
Categorical variable (yes/no)
Time Frame
Intraprocedural
Title
Predictability of secondary AT by analysis of clinical AT map and voltage map
Time Frame
Intraprocedural
Title
Procedure duration time
Time Frame
Intraprocedural
Title
Fluoroscopy time
Time Frame
intraprocedural
Title
Total radiofrequency application time
Time Frame
intraprocedural
Title
Ablated area (cm2)
Time Frame
intraprocedural
Title
Number of blocked lines
Time Frame
intraprocedural
Title
Area of low voltage in sinus map (cm2)
Time Frame
Intraprocedural
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Meyer, MD
Phone
00492119191855
Email
christian.meyer@evk-duesseldorf.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Meyer, MD
Organizational Affiliation
Evangelic Hospital Düsseldorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evangelic Hospital Düsseldorf
City
Düsseldorf
State/Province
North Rhine-Westfalia
ZIP/Postal Code
40217
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Meyer, MD
Phone
00492119191855
Email
christian.meyer@evk-duesseldorf.de
First Name & Middle Initial & Last Name & Degree
Katharina Scherschel, PhD
Email
katharina.scherschel@evk-duesseldorf.de
First Name & Middle Initial & Last Name & Degree
Christian Meyer, MD
First Name & Middle Initial & Last Name & Degree
Ernan Zhu, MD
First Name & Middle Initial & Last Name & Degree
Fares A Alken, MD
Facility Name
Evangelic Hospital Hagen-Haspe
City
Hagen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harilaos Bogossian, MD
Facility Name
Asklepios St. Georg
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Willems, MD
Facility Name
Universitätsklinikum Schleswig Holstein
City
Kiel
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeny Lyan, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32748442
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.
Results Reference
background
PubMed Identifier
32703564
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.
Results Reference
background
PubMed Identifier
31400216
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.
Results Reference
background
PubMed Identifier
31004777
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.
Results Reference
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Ablation of Consecutive Atrial Tachycardia
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