Ventricular Tachycardia Ablation in LVAD Patients (CHANNELED)

September 25, 2023 updated by: Universitätsklinikum Köln

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LVAD patients
Patients with end-stage heart failure with an LVAD implanted undergoing VT ablation.
Other: Ablation
VT ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 month
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
12 month
Mortality (physiological parameter)
Time Frame: 12 month
Assessment of mortality after VT ablation.
12 month
Heart failure Hospitalization (physiological parameter)
Time Frame: 12 month
Assessment of Hospitalization for worsening of Heart Failure after VT ablation.
12 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Köln

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 25, 2023

Primary Completion (Estimated)

January 15, 2024

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHANNELED-Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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