RV PacingNCT04908033
Ultra-high-frequency ECG for Prediction of Left Ventricular Remodeling
An observational study of RV Pacing and Negative Remodeling, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
Trial summary
The main goal of the project is to prove that ultra-high-frequency ECG (UHF-ECG) can be used as a diagnostic tool that allows the prediction of patients susceptible to the negative effect of right ventricular myocardial pacing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RV Pacing, Negative Remodeling, Dyssynchrony
- What is being tested?
- pacemaker implantation
- Type of treatment
- Medical device
- How many people
- 368 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2021to 1 Dec 2025
- Phase
- Observational
- 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
Study population: 360 patients with an indication for permanent pacing due to permanent conduction disease of/below the AV node
Who may be able to join
- expectation of permanent right ventricular pacing with atrio-ventricular delay set to 150/180 ms (130/160 resp.) for sensed/paced atrial events during a follow-up,
- a good quality of images during echocardiography,
- willingness to attend clinical check-ups in the implanting center for at least two years.
- life expectancy of at least 2 years
Who cannot join
- planned cardiac surgery or transcatheter aortic valve implantation
- hypertrophic cardiomyopathy
- an indication for implantable cardioverter-defibrillator, biventricular implantable cardioverter-defibrillator, or biventricular pacemaker
- active myocarditis
- cardiac surgery or coronary revascularization in the last ten days
- persistent/permanent atrial fibrillation during randomization
- severe aortic stenosis
- mitral valvular disease with an indication to intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultra-high-frequency ECG for Prediction of Adverse Left Ventricular Remodeling in Permanent Right Ventricular Pacing
The main goal of the project is to prove that ultra-high-frequency ECG (UHF-ECG) can be used as a diagnostic tool that allows the prediction of patients susceptible to the negative effect of right ventricular myocardial pacing. The prediction will be based on the assessment of electrical dyssynchrony and local depolarization durations of left ventricular depolarization emerging during right ventricular pacing. If proved to be valid in left ventricular negative remodeling prediction, UHF-ECG-derived parameters of ventricular dyssynchrony could be used as markers allowing a lead placement optimization during an implant procedure. This information can help the operator to identify patients with the urgent need for physiological pacing (HB or LBBp) and patients in which a right ventricular myocardial pacing is sufficient and will not lead to the development of the negative left ventricular remodeling.
- Conditions
- RV Pacing, Negative Remodeling, Dyssynchrony, UHF-ECG, Physiological Pacing
- Being tested
- pacemaker implantation
- Keywords
- myocardial pacing, physiological pacing, negative remodeling, dyssynchrony, ultra-high-frequency ECG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pacemaker implantationDevice
pacemaker implantation
| Study group | Role | What they receive |
|---|---|---|
| myocardial pacing group | patients with the pacing lead placed into the right ventricle to obtain myocardial capture Receives: Device: pacemaker implantation | |
| physiological pacing group | patients with the pacing lead placed into the His bundle or left bundle branch area Receives: Device: pacemaker implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
negative remodeling prediction
- 5% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG electrical dyssynchrony parameter
- 5% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG left ventricular lateral wall delay parameter
- 5% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG V6d parameter
- 10% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG left ventricular lateral wall delay parameter
- 10% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG V6d parameter
Measured: 1 year from randomization
Secondary outcomes (2)
RV myocardial to physiological pacing comparison
left ventricular ejection fraction comparison between low risk right ventricular myocardial to physiological pacing group
Measured: 2 years from randomization
UHF-ECG prediction of clinical outcome
occurence of death, myocardial infarction, worsening heart failure or upgrade to resynchronization therapy will be predicted by the duration of UHF-ECG electrical dyssynchrony, and/or left ventricular lateral wall delay and/or V6d parameter
Measured: 3 years from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 May 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RV PacingStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic, Regional Hospital Liberec
- Responsible party
- Principal investigator, Karol Curila, Faculty Hospital Kralovske Vinohrady
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908033
- Sponsor's protocol ID
- EK-VP1421012
- Status last verified
- Mar 2024
- First submitted
- 15 May 2021
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-high-frequency ECG for Prediction of Adverse Left Ventricular Remodeling in Permanent Right Ventricular Pacing
- ClinicalTrials.gov ID
- NCT04908033
- Acronym / sponsor ID
- EK-VP1421012
- Conditions
- RV Pacing, Negative Remodeling, Dyssynchrony, UHF-ECG, Physiological Pacing
- Keywords
- myocardial pacing, physiological pacing, negative remodeling, dyssynchrony, ultra-high-frequency ECG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic, Regional Hospital Liberec
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 1 Jun 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.
The main goal of the project is to prove that ultra-high-frequency ECG (UHF-ECG) can be used as a diagnostic tool that allows the prediction of patients susceptible to the negative effect of right ventricular myocardial pacing. The prediction will be based on the assessment of electrical dyssynchrony and local depolarization durations of left ventricular depolarization emerging during right ventricular pacing. If proved to be valid in left ventricular negative remodeling prediction, UHF-ECG-derived parameters of ventricular dyssynchrony could be used as markers allowing a lead placement optimization during an implant procedure. This information can help the operator to identify patients with the urgent need for physiological pacing (HB or LBBp) and patients in which a right ventricular myocardial pacing is sufficient and will not lead to the development of the negative left ventricular remodeling.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myocardial pacing group | – | Device: pacemaker implantationpatients with the pacing lead placed into the right ventricle to obtain myocardial capture |
| physiological pacing group | – | Device: pacemaker implantationpatients with the pacing lead placed into the His bundle or left bundle branch area |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 360 patients with an indication for permanent pacing due to permanent conduction disease of/below the AV node
Key inclusion criteria (4 listed)
- expectation of permanent right ventricular pacing with atrio-ventricular delay set to 150/180 ms (130/160 resp.) for sensed/paced atrial events during a follow-up,
- a good quality of images during echocardiography,
- willingness to attend clinical check-ups in the implanting center for at least two years.
- life expectancy of at least 2 years
Key exclusion criteria (8 listed)
- planned cardiac surgery or transcatheter aortic valve implantation
- hypertrophic cardiomyopathy
- an indication for implantable cardioverter-defibrillator, biventricular implantable cardioverter-defibrillator, or biventricular pacemaker
- active myocarditis
- cardiac surgery or coronary revascularization in the last ten days
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 |
|---|---|---|
| pacemaker implantationpacemaker implantation | Device | myocardial pacing group, physiological pacing group |
Primary outcome
negative remodeling prediction
Time frame: 1 year from randomization
* 5% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG electrical dyssynchrony parameter * 5% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG left ventricular lateral wall delay parameter * 5% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG V6d parameter * 10% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG left ventricular lateral wall delay parameter * 10% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG V6d parameter
2 secondary outcomes
RV myocardial to physiological pacing comparison
Time frame: 2 years from randomization
UHF-ECG prediction of clinical outcome
Time frame: 3 years from randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RV Pacing and Negative Remodeling, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
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 4 inclusion and 8 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 5 Mar 2025. 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 Czechia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
negative remodeling prediction (time frame: 1 year from randomization). 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 5 Mar 2025.