NCT06063811

Brief 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 ablation in this special subset of patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

September 11, 2023

Last Update Submit

September 25, 2023

Conditions

Ventricular TachycardiaEnd-stage Heart FailureVentricular ArrythmiaLVAD (Left Ventricular Assist Device)

Keywords

Catheter AblationVT Ablation in LVAD patients

Outcome Measures

Primary Outcomes (4)

  • 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)

    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

    12 month

  • Mortality (physiological parameter)

    Assessment of mortality after VT ablation.

    12 month

  • Heart failure Hospitalization (physiological parameter)

    Assessment of Hospitalization for worsening of Heart Failure after VT ablation.

    12 month

Secondary Outcomes (4)

  • Procedure duration (From groin puncture to sheath removal in minutes)

    12 month

  • Fluoroscopy time (minutes)

    12 month

  • Radiofrequency energy used for ablation (in watts; e.g. 40 Watts)

    12 month

  • Number of patients suffering from intraprocedural complication (physiological parameter, e.g. hematoma)

    12 month

Study Arms (1)

LVAD patients

Patients with end-stage heart failure with an LVAD implanted undergoing VT ablation.

Other: Ablation

Interventions

AblationOTHER

VT ablation

LVAD patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • All patients with end-stage heart failure with an LVAD implanted undergoing VT ablation

You may not qualify if:

  • Patients \<18 years, pregnant women, patients undergoing VT ablation without an LVAD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 40101155DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jakob Lüker, MD

    Heart Center University of Cologne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakob Lüker, MD

CONTACT

+49 221 478 82851jakob.lueker@uk-koeln.de

Jan-Hendrik van den Bruck, MD

CONTACT

+49 221 478 84895jan-hendrik.van-den-bruck@uk-koeln.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2023

First Posted

October 3, 2023

Study Start

September 25, 2023

Primary Completion

January 15, 2024

Study Completion

May 15, 2024

Last Updated

October 3, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share