Impact of Pacing Output and Cycle Length on QRS Morphology

Not Applicable

• Conditions: PVC - Premature Ventricular Complex; Catheter Ablation
• Interventions: Diagnostic Test: Additional Pacing maneuvers

• Registration Number: NCT05061498
• Lead Sponsor: Universitätsklinikum Köln

Brief Summary

Current recommendations for pacemapping are based on expert opinion and animals models. Present study sought to evaluate the influence of different parameters of pacemapping on QRS morphology. Pacemapping is performed with different cycle length (fixed burst vs. coupling interval) and stimulation output (maximum output vs. threshold) and resulting QRS complexes are compared to clinical PVC and the standard of care to determine the optimal parameter setting in pacemapping.

Detailed Description

Pacemapping is a common technique to determine to origin of ventricular ectopy during catheter ablation of premature ventricular contractions (PVC). During the pacemapping process an electrical pacing stimulus is applied via the ablation catheter and the resulting QRS complex is compared the clinical target PVC. The higher the consistency between the stimulated QRS complex and the clinical PVC, the nearer the catheter is located to the origin of ectopy.

Current recommendations for the execution of pacemapping are based on expert opinion and animals models. The investigators sought to assess for the first time in a clinical real life setting the different parameters for pacemapping (i.e. Cycle length and stimulation output). Therefore during the pacemapping process in routine PVC ablation pacing is performed with different cycle length (fixed burst vs. coupling interval of PVC) and different electrical output (maximum output vs. stimulation threshold). The resulting QRS morphologies are on the one hand compared to the ablation target (clinical PVC) and on the other hand to the suggest standard of care (Coupling interval at pacing threshold) to determine the optimal setting of parameters in pacemapping.

Study Timeline

• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-09-29
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-08
• Study Start: 2021-12-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All patients undergoing PVC ablation

Exclusion Criteria

• patients <18 years
• patients not able to consent
• pregnancy
• contraindication for PVC ablation
• unavailability of vascular access
• patients with complex congenital heart disease
• expected hemodynamical instability during pacemapping

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Additional Pacing maneuvers	Additional Pacing maneuvers	In all study participants additional pacing maneuvers (cycle lenght and output) are performed

Primary Outcome Measures

Name	Time	Method
Template Matching with clinical PVC	Immediately during PVC ablation. No follow up intended.	Different pacing settings are applied in order to determine the optimal Consistency between paced QRS complex and clinical PVC

Trial Locations

Locations (1)

University Hospital Cologne; 🇩🇪 Cologne, NRW, Germany