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CHANNELED: Ventricular Tachycardia Ablation in LVAD Patients

Sponsor
Universitätsklinikum Köln (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06063811
Collaborator
(none)
50
Enrollment
7.7
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ablation

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Characterization of Ventricular Tachycardia Ablation in End-stage Heart Failure Patients With Left Ventricular Assist Device
Anticipated Study Start Date :
Sep 25, 2023
Anticipated Primary Completion Date :
Jan 15, 2024
Anticipated Study Completion Date :
May 15, 2024

Arms and Interventions

Arm Intervention/Treatment
LVAD patients

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

Other: Ablation
VT ablation

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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

  3. Mortality (physiological parameter) [12 month]

    Assessment of mortality after VT ablation.

  4. Heart failure Hospitalization (physiological parameter) [12 month]

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

Secondary Outcome Measures

  1. Procedure duration (From groin puncture to sheath removal in minutes) [12 month]

    Evaluation of the duration of VT ablation procedures in LVAD patients

  2. Fluoroscopy time (minutes) [12 month]

    Evaluation of the fluroscopy use (in minutes)

  3. Radiofrequency energy used for ablation (in watts; e.g. 40 Watts) [12 month]

    Evaluation of the maximum RF-energy used for ablation

  4. Number of patients suffering from intraprocedural complication (physiological parameter, e.g. hematoma) [12 month]

    Evaluation of intraprocedural complications of VT ablation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universitätsklinikum Köln

Investigators

  • Principal Investigator: Jakob Lüker, MD, Heart Center University of Cologne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitätsklinikum Köln
ClinicalTrials.gov Identifier:
NCT06063811
Other Study ID Numbers:
  • CHANNELED-Registry
First Posted:
Oct 3, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universitätsklinikum Köln
Catheter Ablation
VT Ablation in LVAD patients
Additional relevant MeSH terms:
Heart Failure
Tachycardia
Tachycardia, Ventricular

Study Results

No Results Posted as of Oct 3, 2023