Impact of Pacing Output and Cycle Length on QRS Morphology
Primary Purpose
PVC - Premature Ventricular Complex, Catheter Ablation
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Additional Pacing maneuvers
Sponsored by
About this trial
This is an interventional diagnostic trial for PVC - Premature Ventricular Complex focused on measuring Catheter ablation of PVC, Pacemapping
Eligibility Criteria
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
Sites / Locations
- University Hospital CologneRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Additional Pacing maneuvers
Arm Description
In all study participants additional pacing maneuvers (cycle lenght and output) are performed
Outcomes
Primary Outcome Measures
Template Matching with clinical PVC
Different pacing settings are applied in order to determine the optimal Consistency between paced QRS complex and clinical PVC
Secondary Outcome Measures
Full Information
NCT ID
NCT05061498
First Posted
May 11, 2021
Last Updated
November 5, 2021
Sponsor
Universitätsklinikum Köln
1. Study Identification
Unique Protocol Identification Number
NCT05061498
Brief Title
Impact of Pacing Output and Cycle Length on QRS Morphology
Official Title
Impact of Pacing Output and Cycle Length on QRS Morphology in Ablation of Premature Ventricular Contractions
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Köln
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PVC - Premature Ventricular Complex, Catheter Ablation
Keywords
Catheter ablation of PVC, Pacemapping
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Additional Pacing maneuvers
Arm Type
Other
Arm Description
In all study participants additional pacing maneuvers (cycle lenght and output) are performed
Intervention Type
Diagnostic Test
Intervention Name(s)
Additional Pacing maneuvers
Intervention Description
In order to determine the optimal setting for pacemapping in all participants additional pacing maneuvers (output and cycle length) are performed
Primary Outcome Measure Information:
Title
Template Matching with clinical PVC
Description
Different pacing settings are applied in order to determine the optimal Consistency between paced QRS complex and clinical PVC
Time Frame
Immediately during PVC ablation. No follow up intended.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan-Hendrik van den Bruck, MD
Phone
+49 22147884895
Email
jan-hendrik.van-den-bruck@uk-koeln.de
First Name & Middle Initial & Last Name or Official Title & Degree
Jakob Lüker, MD
Phone
+49 221 478 82851
Email
jakob.lueker@uk-koeln.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob Lüker, MD
Organizational Affiliation
Heart Center University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50936
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Steven
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Pacing Output and Cycle Length on QRS Morphology
We'll reach out to this number within 24 hrs