Ventricular TachycardiaCHANNELEDNCT06063811
Ventricular Tachycardia Ablation in LVAD Patients
An observational study of Ventricular Tachycardia and End-stage Heart Failure, run by Universitätsklinikum Köln.
Trial summary
The CHANNELED-Registry is a multicenter retrospective study to (1) systematically assess the mechanism and origin of ventricular tachycardia in patients with end-stage heart failure carrying an left ventricular assist device (LVAD) and (2) to evaluate procedural parameters and outcome of ventricular tachycardia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, End-stage Heart Failure, Ventricular Arrythmia
- What is being tested?
- Ablation
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2023to 15 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All patients with end-stage heart failure and an implanted LVAD which underwent ablation of ventricular tachycardia will be included in this retrospective observational study.
Who may be able to join
- All patients with end-stage heart failure with an LVAD implanted undergoing VT ablation
Who cannot join
- Patients <18 years, pregnant women, patients undergoing VT ablation without an LVAD
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Characterization of Ventricular Tachycardia Ablation in End-stage Heart Failure Patients With Left Ventricular Assist Device
The CHANNELED-Registry is a multicenter retrospective study to (1) systematically assess the mechanism and origin of ventricular tachycardia in patients with end-stage heart failure carrying an left ventricular assist device (LVAD) and (2) to evaluate procedural parameters and outcome of ventricular tachycardia ablation in this special subset of patients.
- Conditions
- Ventricular Tachycardia, End-stage Heart Failure, Ventricular Arrythmia, LVAD (Left Ventricular Assist Device)
- Being tested
- Ablation
- Keywords
- Catheter Ablation, VT Ablation in LVAD patients
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationOther
VT ablation
| Study group | Role | What they receive |
|---|---|---|
| LVAD patients | Patients with end-stage heart failure with an LVAD implanted undergoing VT ablation. Receives: Other: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanism of ventricular tachycardia in LVAD patients (descriptive name of scale)
Assessment of the mechanism of VT in LVAD patients (e.g LVAD cannula related vs. related to substrate of underlying heart disease)
Measured: 12 month
Number of patients with ventricular tachycardia recurrence in device interrogation (physiological parameter)
Assessment of VT recurrence after ablation: Device interrogation and readout of ICD Holter
Measured: 12 month
Mortality (physiological parameter)
Assessment of mortality after VT ablation.
Measured: 12 month
Heart failure Hospitalization (physiological parameter)
Assessment of Hospitalization for worsening of Heart Failure after VT ablation.
Measured: 12 month
Secondary outcomes (4)
Procedure duration (From groin puncture to sheath removal in minutes)
Evaluation of the duration of VT ablation procedures in LVAD patients
Measured: 12 month
Fluoroscopy time (minutes)
Evaluation of the fluroscopy use (in minutes)
Measured: 12 month
Radiofrequency energy used for ablation (in watts; e.g. 40 Watts)
Evaluation of the maximum RF-energy used for ablation
Measured: 12 month
Number of patients suffering from intraprocedural complication (physiological parameter, e.g. hematoma)
Evaluation of intraprocedural complications of VT ablation
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start25 Sep 2023 (estimated)
- Primary completion15 Jan 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakob Lüker, MD, Principal investigator, Heart Center University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063811
- Sponsor's protocol ID
- CHANNELED-Registry
- Acronym
- CHANNELED
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van den Bruck JH, Hohendanner F, Heil E, Albert K, Duncker D, Estner H, Deneke T, Parwani A, Potapov E, Seuthe K, Wormann J, Sultan A, Schipper JH, Eckardt L, Doldi F, Lugenbiel P, Servatius H, Thalmann G, Reichlin T, Khalaph M, Guckel D, Sommer P, Steven D, Luker J. Characterization of ventricular tachycardia ablation in end-stage heart failure patients with left ventricular assist device (CHANNELED registry). Europace. 2025 Mar 28;27(4):euaf054. doi: 10.1093/europace/euaf054.
PubMed 40101155
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Ventricular Tachycardia Ablation in End-stage Heart Failure Patients With Left Ventricular Assist Device
- ClinicalTrials.gov ID
- NCT06063811
- Acronym / sponsor ID
- CHANNELED / CHANNELED-Registry
- Conditions
- Ventricular Tachycardia, End-stage Heart Failure, Ventricular Arrythmia, LVAD (Left Ventricular Assist Device)
- Keywords
- Catheter Ablation, VT Ablation in LVAD patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Study start
- 25 Sep 2023 (estimated)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 3 Oct 2023 (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.
The CHANNELED-Registry is a multicenter retrospective study to (1) systematically assess the mechanism and origin of ventricular tachycardia in patients with end-stage heart failure carrying an left ventricular assist device (LVAD) and (2) to evaluate procedural parameters and outcome of ventricular tachycardia ablation in this special subset of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LVAD patients | – | Other: AblationPatients with end-stage heart failure with an LVAD implanted undergoing VT ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with end-stage heart failure and an implanted LVAD which underwent ablation of ventricular tachycardia will be included in this retrospective observational study.
Key inclusion criteria (1 listed)
- All patients with end-stage heart failure with an LVAD implanted undergoing VT ablation
Key exclusion criteria (1 listed)
- Patients <18 years, pregnant women, patients undergoing VT ablation without an LVAD
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 |
|---|---|---|
| AblationVT ablation | Other | LVAD patients |
Primary outcome
Mechanism of ventricular tachycardia in LVAD patients (descriptive name of scale)
Time frame: 12 month
Assessment of the mechanism of VT in LVAD patients (e.g LVAD cannula related vs. related to substrate of underlying heart disease)
Number of patients with ventricular tachycardia recurrence in device interrogation (physiological parameter)
Time frame: 12 month
Assessment of VT recurrence after ablation: Device interrogation and readout of ICD Holter
Mortality (physiological parameter)
Time frame: 12 month
Assessment of mortality after VT ablation.
Heart failure Hospitalization (physiological parameter)
Time frame: 12 month
Assessment of Hospitalization for worsening of Heart Failure after VT ablation.
4 secondary outcomes
Procedure duration (From groin puncture to sheath removal in minutes)
Time frame: 12 month
Fluoroscopy time (minutes)
Time frame: 12 month
Radiofrequency energy used for ablation (in watts; e.g. 40 Watts)
Time frame: 12 month
Number of patients suffering from intraprocedural complication (physiological parameter, e.g. hematoma)
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Derived from this study: PubMed 40101155van den Bruck JH, Hohendanner F, Heil E, Albert K, Duncker D, Estner H, Deneke T, Parwani A, Potapov E, Seuthe K, Wormann J, Sultan A, Schipper JH, Eckardt L, Doldi F, Lugenbiel P, Servatius H, Thalmann G, Reichlin T, Khalaph M, Guckel D, Sommer P, Steven D, Luker J. Characterization of ventricular tachycardia ablation in end-stage heart failure patients with left ventricular assist device (CHANNELED registry). Europace. 2025 Mar 28;27(4):euaf054. doi: 10.1093/europace/euaf054.
- 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. This study is not recruiting at the moment.
Jakob Lüker, MD principal investigator
Heart Center University of Cologne
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and End-stage Heart Failure, run by Universitätsklinikum Köln.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jakob Lüker, MD (+49 221 478 82851, jakob.lueker@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanism of ventricular tachycardia in LVAD patients (descriptive name of scale) (time frame: 12 month). The study lists 4 primary outcomes in all. 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 NCT06063811, which also lists 1 linked publication.
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 3 Oct 2023.