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Impact of Pacing Output and Cycle Length on QRS Morphology

NCT ID: NCT05061498

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-11-01

Brief Summary

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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

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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.

Conditions

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PVC - Premature Ventricular Complex Catheter Ablation

Keywords

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Catheter ablation of PVC Pacemapping

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Additional Pacing maneuvers

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

Group Type OTHER

Additional Pacing maneuvers

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Additional Pacing maneuvers

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Köln

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jakob Lüker, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center University of Cologne

Locations

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University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jan-Hendrik van den Bruck, MD

Role: CONTACT

Phone: +49 22147884895

Email: [email protected]

Jakob Lüker, MD

Role: CONTACT

Phone: +49 221 478 82851

Email: [email protected]

Facility Contacts

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Daniel Steven

Role: primary

Other Identifiers

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Pacemap-Study

Identifier Type: -

Identifier Source: org_study_id