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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04778696
Other study ID # UKK-PASTPVC-2018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 5, 2018
Est. completion date October 1, 2022

Study information

Verified date February 2021
Source Universitätsklinikum Köln
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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%).


Recruitment information / eligibility

Status Recruiting
Enrollment 144
Est. completion date October 1, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Intervention

Procedure:
PASO Pacemapping
Using the PASO pacemapping visualisation module of CARTO3
Conventional Pacemapping
without visualisation in 3D mapping

Locations

Country Name City State
Germany University Hospital Cologne Cologne

Sponsors (2)

Lead Sponsor Collaborator
Universitätsklinikum Köln Biosense Webster, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

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