Impact of Pacing Output and Cycle Length on QRS Morphology

Impact of Pacing Output and Cycle Length on QRS Morphology in Ablation of Premature Ventricular Contractions

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.

Study Overview

• Status: Recruiting
• Conditions: Catheter Ablation; PVC - Premature Ventricular Complex
• Intervention / Treatment: Diagnostic test: Additional Pacing maneuvers

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan-Hendrik van den Bruck, MD; Phone Number: +49 22147884895; Email: jan-hendrik.van-den-bruck@uk-koeln.de
• Study Contact Backup: Name: Jakob Lüker, MD; Phone Number: +49 221 478 82851; Email: jakob.lueker@uk-koeln.de

Study Locations

• Germany
  • NRW
    • Cologne, NRW, Germany, 50936
      • Recruiting
      • University Hospital Cologne
      • Contact: Daniel Steven

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Additional Pacing maneuvers; In all study participants additional pacing maneuvers (cycle lenght and output) are performed	Diagnostic test: Additional Pacing maneuvers; In order to determine the optimal setting for pacemapping in all participants additional pacing maneuvers (output and cycle length) are performed

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Köln
• Investigators: Principal Investigator: Jakob Lüker, MD, Heart Center University of Cologne

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2021
• Primary Completion (ANTICIPATED): February 1, 2022
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (ACTUAL): September 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Catheter ablation of PVC; Pacemapping
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Cardiac Complexes, Premature; Premature Birth; Ventricular Premature Complexes
• Other Study ID Numbers: Pacemap-Study

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