Heart ArrhythmiaCONCLUDENCT05239364
Ablation of Consecutive Atrial Tachycardia
A study testing Catheter ablation in people with Heart Arrhythmia and Heart Diseases, run by Evangelical Hospital Düsseldorf at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrhythmia, Heart Diseases, Arrhythmias, Cardiac
- What is being tested?
- Catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesGermany
- Study dates
- 22 Dec 2020to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
Vivantes Klinikum Am Urban Berlin
Berlin
Niels C Ewertsen, MD
- Recruiting
Evangelic Hospital Düsseldorf
Düsseldorf, North Rhine-Westfalia, 40217
Christian Meyer, MD, 00492119191855, christian.meyer@evk-duesseldorf.de
Katharina Scherschel, PhD, katharina.scherschel@evk-duesseldorf.de
- Recruiting
Evangelic Hospital Hagen-Haspe
Hagen
Harilaos Bogossian, MD
- Recruiting
Asklepios St. Georg
Hamburg, Free and Hanseatic City of Hamburg
Stephan Willems, MD
- Recruiting
Städtisches Klinikum Karlsruhe
Karlsruhe
Armin Luik, MD
- Recruiting
Universitätsklinikum Schleswig Holstein
Kiel
Evgeny Lyan, MD
About this study
Official title: Ablation of CONseCutive atriaL Tachycardia gUided by Ultra-high-DEnsity Mapping
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.
- Being tested
- Catheter ablation
- Keywords
- Atrial fibrillation, Atrial tachycardia, Pulmonary vein isolation, Electroanatomical mapping, High density mapping
- Medical subject headings
- Arrhythmias, Cardiac, Heart Diseases, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
Catheter-based ablation of arrhythmias using radiofrequency.
| Study group | Role | What they receive |
|---|---|---|
| Standard approach | Experimental | Patients will receive a standard approach for ablation of atrial tachycardia. Receives: Procedure: Catheter ablation |
| Minimalized approach | Experimental | Patients will receive a minimalized approach for ablation of atrial tachycardia. Receives: Procedure: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of any sustained arrhythmia (>30 sec.)
Measured: 1 year
Secondary outcomes (8)
Inducibility of atrial tachycardia (AT) after ablation of clinical/primary AT (partial success)
Categorical variable (yes/no)
Measured: Intraprocedural
Predictability of secondary AT by analysis of clinical AT map and voltage map
Measured: Intraprocedural
Procedure duration time
Measured: Intraprocedural
Fluoroscopy time
Measured: intraprocedural
Total radiofrequency application time
Measured: intraprocedural
Ablated area (cm2)
Measured: intraprocedural
Number of blocked lines
Measured: intraprocedural
Area of low voltage in sinus map (cm2)
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start22 Dec 2020
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evangelical Hospital Düsseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Meyer, Evangelical Hospital Düsseldorf
- Investigators
- Christian Meyer, MD, Principal investigator, Evangelic Hospital Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239364
- Sponsor's protocol ID
- CONCLUDE
- Acronym
- CONCLUDE
- Status last verified
- Apr 2026
- First submitted
- 10 Jan 2022
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 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.
PubMed 41435855Jungen 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.
PubMed 32748442Derval 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.
PubMed 32703564Meyer 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.
PubMed 31400216Takigawa 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.
PubMed 31004777
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation of CONseCutive atriaL Tachycardia gUided by Ultra-high-DEnsity Mapping
- ClinicalTrials.gov ID
- NCT05239364
- Acronym / sponsor ID
- CONCLUDE / CONCLUDE
- Keywords
- Atrial fibrillation, Atrial tachycardia, Pulmonary vein isolation, Electroanatomical mapping, High density mapping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Evangelical Hospital DüsseldorfUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard approach | Experimental | Procedure: Catheter ablationPatients will receive a standard approach for ablation of atrial tachycardia. |
| Minimalized approach | Experimental | Procedure: Catheter ablationPatients will receive a minimalized approach for ablation of atrial tachycardia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter ablationCatheter-based ablation of arrhythmias using radiofrequency. | Procedure or surgery | Minimalized approach, Standard approach |
Primary outcome
Recurrence of any sustained arrhythmia (>30 sec.)
Time frame: 1 year
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 41435855Meyer 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.
- Background: PubMed 32748442Jungen 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.
- Background: PubMed 32703564Derval 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.
- Background: PubMed 31400216Meyer 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.
- Background: PubMed 31004777Takigawa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Meyer, MD principal investigator
Evangelic Hospital Düsseldorf
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation in people with Heart Arrhythmia and Heart Diseases, run by Evangelical Hospital Düsseldorf at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Meyer, MD (00492119191855, christian.meyer@evk-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of any sustained arrhythmia (>30 sec.) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05239364, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.