PASO Automated Template Matching for PVC Ablation

NCT04778696 | Unknown

• 1 other identifier: UKK-PASTPVC-2018
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Pacemapping is an essential tool during ablation of idiopathic PVC and VT. Automated template matching has been shown to have a significant influence on PVC ablation procedures, but the PASO module of CARTO3 has not been studied in a randomized trial. The Aim of this study is to evaluate the additional benefit of PASO template matching on PVC ablation procedure with regard to procedural parameters and outcome when compared with conventional pace mapping. A total of 144 pts will be randomised in a 1:1 fashion to PVC ablation guided by conventional pacemapping vs PVC ablation guided by PASO pacemapping. Patients will be follow up with Holter-ECG and TTE after 3 and 12 months.

Conditions

PVC - Premature Ventricular Complex; Cardiomyopathies; Heart Failure; Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• PVC recurrence in Holter ECG

  Assessment of PVC as % of total number heart beats in a 24 hours Holter ECG

  12 weeks after ablation procedure

Secondary Outcomes (5)

• Symptomatic recurrence

  between 3 and 12 months after ablation

• LV ejection fraction assessment (%)

  between 3 months and 12 months after ablation

• Procedure duration

  From groin puncture to sheath removal

• Prcedural fluoroscopy parameters

  From groin puncture to sheath removal

• Procedural ablation parameters

  From groin puncture to sheath removal

Study Arms (2)

conventional pace mapping

ACTIVE COMPARATOR

Conventional PVC pace mapping without visual guidance of PASO

Procedure: Conventional Pacemapping

PASO pace mapping

EXPERIMENTAL

PASO pace mapping with visualisation in CARTO3

Procedure: PASO Pacemapping

Interventions

PASO Pacemapping PROCEDURE

Using the PASO pacemapping visualisation module of CARTO3

PASO pace mapping

Conventional Pacemapping PROCEDURE

without visualisation in 3D mapping

conventional pace mapping

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Informed, written consent
• ventricular arrhythmia (PVC or VT) with indication for CA

You may not qualify if:

• Patients under guardianship or with mental disorders / disabilities
• Polymorphic PVC / VT
• ongoing myocardial ischaemia
• pregnancy
• valve replacement that prevents access to the suspected site of PVC origin

Sponsors & Collaborators

• Universitätsklinikum Köln: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

University Hospital Cologne

Cologne, 50937, Germany

RECRUITING

MeSH Terms

Conditions

Ventricular Premature Complexes; Cardiomyopathies; Heart Failure; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will be masked to treatment arm. Investigator performing statistical analysis and adjudicating outcomes will be masked to treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 simple randomisation

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: March 3, 2021
• Study Start: February 5, 2018
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)