PASO Automated Template Matching for PVC Ablation (PAsT-PVC)

PASO - Automated Template Matching for PVC Ablation: A Randomised Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Cardiomyopathies; Ventricular Tachycardia; PVC - Premature Ventricular Complex
• Intervention / Treatment: Procedure: Conventional Pacemapping; Procedure: PASO Pacemapping

Detailed Description

Introduction / Rationale Premature ventricular contractions (PVC) in the otherwise healthy heart are not associated with increased mortality in the absence of a short coupling interval or a compromised left ventricular function and do not require treatment if asymptomatic . Symptomatic idiopathic PVC or VT on the other hand can burden patients with recurring palpitations, dizziness, dyspnea and possibly syncope in cases of fast VT. A reversible decrease in left ventricular function as a result of a high PVC burden has been reported even in patients with no underlying cardiomyopathy . Radiofrequency Ablation (RFA) is a well-established method to treat idiopathic PVC and VT, and is associated with satisfying long-term results. 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.

Aim of the study 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.

Hypothesis PASO guidance during PVC / VT ablation has a significant impact on outcome after catheter ablation of idiopathic PVC / VT.

Study design This study is planned as a two-center trial. All patients presenting for de novo ablation of idiopathic ventricular arrhythmia will be included and randomized in a 1:1 fashion in this open-label, two-center, randomized controlled trial.

In patients randomized to the PASO / intervention group pacemapping will be guided by automated template matching of the PASO module of CARTO3.

In patients randomized to the conventional / control group conventional pacemapping will be employed.

A 3D electroanatomic geometry including activation mapping will be acquired in all patients using CARTO3. Sedation, catheters and monitoring during and after CA, will not differ from standard clinical practice and will be the same for both groups.

Follow-up after 3 and 12 months will assess PVC burden by Holter ECG, symptoms through a standardized questionnaire and LV function by TTE

Duration and study size Based on prior findings ("Impact of Automated Template Matching during PVC Ablation: Results from a Randomized Controlled Trial" Lüker et al. ESC 2014 poster presentation) 144 pts have to be randomized to detect a significant difference with respect to ablation success at follow-up (alpha 0.05, power 80%).

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50937
    • Recruiting
    • University Hospital Cologne
    • Principal Investigator: Jakob Lüker, MD
    • Principal Investigator: Daniel Steven, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: conventional pace mapping; Conventional PVC pace mapping without visual guidance of PASO	Procedure: Conventional Pacemapping; without visualisation in 3D mapping
EXPERIMENTAL: PASO pace mapping; PASO pace mapping with visualisation in CARTO3	Procedure: PASO Pacemapping; Using the PASO pacemapping visualisation module of CARTO3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic recurrence	recurrence of PVC according to the patients symptoms	between 3 and 12 months after ablation
LV ejection fraction assessment (%)	Change in LV ejection fraction after ablation (%)	between 3 months and 12 months after ablation
Procedure duration	Procedure duration (min)	From groin puncture to sheath removal
Prcedural fluoroscopy parameters	Fluoroscopy dose (Gy x cm2) and time (min)	From groin puncture to sheath removal
Procedural ablation parameters	Number of RF lesions (n) and acute ablation success (cessation of PVC)	From groin puncture to sheath removal

Collaborators and Investigators

• Sponsor: Universitätsklinikum Köln
• Collaborators: Biosense Webster, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 5, 2018
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (ACTUAL): March 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Cardiac Complexes, Premature; Tachycardia; Tachycardia, Ventricular; Cardiomyopathies; Ventricular Premature Complexes
• Other Study ID Numbers: UKK-PASTPVC-2018

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