Impact of Pacing Output and Cycle Length on QRS Morphology
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2021
CompletedFirst Posted
Study publicly available on registry
September 29, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedNovember 8, 2021
November 1, 2021
2 months
May 11, 2021
November 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
Additional Pacing maneuvers
OTHERIn all study participants additional pacing maneuvers (cycle lenght and output) are performed
Interventions
In order to determine the optimal setting for pacemapping in all participants additional pacing maneuvers (output and cycle length) are performed
Eligibility Criteria
You may qualify if:
- All patients undergoing PVC ablation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50936, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jakob Lüker, MD
Heart Center University of Cologne
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2021
First Posted
September 29, 2021
Study Start
December 1, 2021
Primary Completion
February 1, 2022
Study Completion
November 1, 2022
Last Updated
November 8, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share