NCT05061498

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

November 8, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

May 11, 2021

Last Update Submit

November 5, 2021

Conditions

Keywords

Catheter ablation of PVCPacemapping

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

OTHER

In all study participants additional pacing maneuvers (cycle lenght and output) are performed

Diagnostic Test: Additional Pacing maneuvers

Interventions

In order to determine the optimal setting for pacemapping in all participants additional pacing maneuvers (output and cycle length) are performed

Additional Pacing maneuvers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, PrematureArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jakob Lüker, MD

    Heart Center University of Cologne

    PRINCIPAL INVESTIGATOR

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

Locations