PVC - Premature Ventricular ComplexNCT05061498
Impact of Pacing Output and Cycle Length on QRS Morphology
A study testing Additional Pacing maneuvers in people with PVC - Premature Ventricular Complex and Catheter Ablation, run by Universitätsklinikum Köln at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PVC - Premature Ventricular Complex, Catheter Ablation
- What is being tested?
- Additional Pacing maneuvers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing PVC ablation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50936
Daniel Steven
About this study
Official title: Impact of Pacing Output and Cycle Length on QRS Morphology in Ablation of Premature Ventricular Contractions
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.
Read the 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.
- Being tested
- Additional Pacing maneuvers
- Keywords
- Catheter ablation of PVC, Pacemapping
- Medical subject headings
- Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional Pacing maneuversDiagnostic test
In order to determine the optimal setting for pacemapping in all participants additional pacing maneuvers (output and cycle length) are performed
| Study group | Role | What they receive |
|---|---|---|
| Additional Pacing maneuvers | Other | In all study participants additional pacing maneuvers (cycle lenght and output) are performed Receives: Diagnostic Test: Additional Pacing maneuvers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Template Matching with clinical PVC
Different pacing settings are applied in order to determine the optimal Consistency between paced QRS complex and clinical PVC
Measured: Immediately during PVC ablation. No follow up intended.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PVC - Premature Ventricular ComplexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakob Lüker, MD, Principal investigator, Heart Center University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061498
- Sponsor's protocol ID
- Pacemap-Study
- Status last verified
- Nov 2021
- First submitted
- 11 May 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pacing Output and Cycle Length on QRS Morphology in Ablation of Premature Ventricular Contractions
- ClinicalTrials.gov ID
- NCT05061498
- Acronym / sponsor ID
- Pacemap-Study
- Keywords
- Catheter ablation of PVC, Pacemapping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Additional Pacing maneuvers | Other | Diagnostic Test: Additional Pacing maneuversIn all study participants additional pacing maneuvers (cycle lenght and output) are performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing PVC ablation
Key exclusion criteria (7 listed)
- patients <18 years
- patients not able to consent
- pregnancy
- contraindication for PVC ablation
- unavailability of vascular access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional Pacing maneuversIn order to determine the optimal setting for pacemapping in all participants additional pacing maneuvers (output and cycle length) are performed | Diagnostic test | Additional Pacing maneuvers |
Primary outcome
Template Matching with clinical PVC
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakob Lüker, MD principal investigator
Heart Center University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional Pacing maneuvers in people with PVC - Premature Ventricular Complex and Catheter Ablation, run by Universitätsklinikum Köln at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan-Hendrik van den Bruck, MD (+49 22147884895, jan-hendrik.van-den-bruck@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Template Matching with clinical PVC (time frame: Immediately during PVC ablation. No follow up intended.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.