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NCT06063811 Clinical Trial

Ventricular Tachycardia Ablation in LVAD Patients

Ventricular Tachycardia Clinical Trial

— CHANNELED  

Official title:
Characterization of Ventricular Tachycardia Ablation in End-stage Heart Failure Patients With Left Ventricular Assist Device

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06063811
Other study ID # CHANNELED-Registry
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 25, 2023
Est. completion date May 15, 2024

Study information
Verified date September 2023
Source Universitätsklinikum Köln
Contact Jakob Lüker, MD
Phone +49 221 478 82851
Email jakob.lueker@uk-koeln.de
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 ablation in this special subset of patients.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date May 15, 2024
Est. primary completion date January 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients with end-stage heart failure with an LVAD implanted undergoing VT ablation Exclusion Criteria: - Patients <18 years, pregnant women, patients undergoing VT ablation without an LVAD

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Ablation
VT ablation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Universitätsklinikum Köln

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Mortality (physiological parameter) Assessment of mortality after VT ablation. 12 month
Primary Heart failure Hospitalization (physiological parameter) Assessment of Hospitalization for worsening of Heart Failure after VT ablation. 12 month
Secondary Procedure duration (From groin puncture to sheath removal in minutes) Evaluation of the duration of VT ablation procedures in LVAD patients 12 month
Secondary Fluoroscopy time (minutes) Evaluation of the fluroscopy use (in minutes) 12 month
Secondary Radiofrequency energy used for ablation (in watts; e.g. 40 Watts) Evaluation of the maximum RF-energy used for ablation 12 month
Secondary Number of patients suffering from intraprocedural complication (physiological parameter, e.g. hematoma) Evaluation of intraprocedural complications of VT ablation 12 month
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