Impact of Pacing Output and Cycle Length on QRS Morphology

Sponsor
Universitätsklinikum Köln (Other)
Overall Status
Recruiting
CT.gov ID
NCT05061498
Collaborator
(none)
50
1
1
11
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Additional Pacing maneuvers
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Impact of Pacing Output and Cycle Length on QRS Morphology in Ablation of Premature Ventricular Contractions
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Cologne Cologne NRW Germany 50936

Sponsors and Collaborators

  • Universitätsklinikum Köln

Investigators

  • Principal Investigator: Jakob Lüker, MD, Heart Center University of Cologne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitätsklinikum Köln
ClinicalTrials.gov Identifier:
NCT05061498
Other Study ID Numbers:
  • Pacemap-Study
First Posted:
Sep 29, 2021
Last Update Posted:
Nov 8, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universitätsklinikum Köln
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 8, 2021