Ventricular Tachycardia Ablation in LVAD Patients

Not yet recruiting

• Conditions: Ventricular Tachycardia; End-stage Heart Failure; Ventricular Arrythmia; LVAD (Left Ventricular Assist Device)
• Interventions: Other: Ablation

• Registration Number: NCT06063811
• Lead Sponsor: Universitätsklinikum Köln

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-11
• Study Start: 2023-09-25
• Study First Submitted QC: 2023-09-25
• Last Update Submitted: 2023-09-25
• Study First Posted: 2023-10-03
• Last Update Posted: 2023-10-03
• Primary Completion: 2024-01-15
• Study Completion: 2024-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LVAD patients	Ablation	Patients with end-stage heart failure with an LVAD implanted undergoing VT ablation.

Primary Outcome Measures

Name	Time	Method
Number of patients with ventricular tachycardia recurrence in device interrogation (physiological parameter)	12 month	Assessment of VT recurrence after ablation: Device interrogation and readout of ICD Holter
Mortality (physiological parameter)	12 month	Assessment of mortality after VT ablation.
Heart failure Hospitalization (physiological parameter)	12 month	Assessment of Hospitalization for worsening of Heart Failure after VT ablation.
Mechanism of ventricular tachycardia in LVAD patients (descriptive name of scale)	12 month	Assessment of the mechanism of VT in LVAD patients (e.g LVAD cannula related vs. related to substrate of underlying heart disease)

Secondary Outcome Measures

Name	Time	Method
Number of patients suffering from intraprocedural complication (physiological parameter, e.g. hematoma)	12 month	Evaluation of intraprocedural complications of VT ablation
Radiofrequency energy used for ablation (in watts; e.g. 40 Watts)	12 month	Evaluation of the maximum RF-energy used for ablation
Procedure duration (From groin puncture to sheath removal in minutes)	12 month	Evaluation of the duration of VT ablation procedures in LVAD patients
Fluoroscopy time (minutes)	12 month	Evaluation of the fluroscopy use (in minutes)