BradyarrhythmiaNCT04697797
Mechanical and Electrical Dyssynchrony During His-Bundle Pacing Versus His-Bundle Area Right Ventricular Pacing
An observational study of Bradyarrhythmia, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The aim of this study is to evaluate mechanical and electrical cardiac dyssynchrony in patients with pacemakers and the right ventricular electrode implanted in His Bundle area. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bradyarrhythmia
- What is being tested?
- Device Programming
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 14 Dec 2020to 31 Dec 2022
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bradyarrhythmia and indications for de novo permanent pacemaker implantation. The decision for pacing lead placement in His Bundle is left for physician discretion. Patients after pacemaker system implantation with His Bundle successfully pacing are to be asked to participate in the study. After having written informed consent obtained patients are to be scheduled for ventricular synchrony evaluation with ECHO and ECG after 3-6 months after implant (mid-term) and after 12 months (long-term).
Who may be able to join
- all adult patients after implantation of pacemaker system with pacing lead successfully captured His Bundle (selectively or/and nonselectively)
Who cannot join
- not willing or incapable to give written informed consent;
- previous implanted cardiac electronic device (pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy device)
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Electrocardiology Medical University of Lodz
Lodz, 93-216
Krzysztof A Kaczmarek, MD, PhD, +48 42 201 43 60, krzysztof.kaczmarek@umed.lodz.pl
About this study
Official title: Mechanical and Electrical Dyssynchrony During His-Bundle Pacing (Selective and Non-selective) Versus His-Bundle Area Right Ventricular Pacing
The aim of this study is to evaluate mechanical and electrical cardiac dyssynchrony in patients with pacemakers and the right ventricular electrode implanted in His Bundle area.
Read the detailed description
Permanent His Bundle Pacing (HBP) is a well-known method of cardiac pacing which is increasingly used in everyday practice. After lead implantation in His Bundle area (HBA) capture of various tissues can be achieved: A. right ventricular myocardium near to HBP; B. cardiac conduction system selectively or nonselectively (with concomitant regional myocardium activation). The different excitability and refractory periods decide which tissue, myocardium or/and the conduction system is effectively paced. A lot of clinical trials revealed the advantage of HBP over apical ventricular pacing (AVP). HBP improves clinical (NYHA, quality of life, hospitalization rate) and echocardiographic (left ventricular dimension and ejection fraction) indicators of heart failure.
We are going to compare mechanical and electrical synchrony during the various type of myocardium activation: HBP (nsHBP or sHBP), RV pacing near HBA and native heart rhythm (if possible) in each patient recruited to the study. Adequate pacemaker programming will allow achieving different activations as shown above. The mechanical synchrony will be estimated by transthoracic echocardiography and the electrical one by the detailed analysis of ECG.
- Conditions
- Bradyarrhythmia
- Being tested
- Device Programming
- Keywords
- His Bundle Pacing, Dyssynchrony, Echocardiography, ECG
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device ProgrammingOther
Also called Echocardiography, ECG
Intervention includes (1) pacemaker reprogramming (2) echocardiographic parameters acquisition (3) ECG recording
What is being measured
The primary outcome is the main question the study is designed to answer.
Interventricular mechanical delay
InterVentricular Mechanical Dyssynchrony Parameter 1
Measured: Mid-term: 3-6 months after pacemaker implantation
Interventricular mechanical delay
InterVentricular Mechanical Dyssynchrony Parameter 1
Measured: Long term: 12-15 months after pacemaker implantation
Free-wall-LV-to-RV-delay
InterVentricular Mechanical Dyssynchrony Parameter 2
Measured: Mid-term: 3-6 months after pacemaker implantation
Free-wall-LV-to-RV-delay
InterVentricular Mechanical Dyssynchrony Parameter 2
Measured: Long term: 12-15 months after pacemaker implantation
Septal-to-posterior wall motion delay
IntraVentricular Mechanical Dyssynchrony Parameter 1
Measured: Mid-term: 3-6 months after pacemaker implantation
Septal-to-posterior wall motion delay
IntraVentricular Mechanical Dyssynchrony Parameter 1
Measured: Long term: 12-15 months after pacemaker implantation
Opposing wall motion delay
IntraVentricular Mechanical Dyssynchrony Parameter 2
Measured: Long term: 12-15 months after pacemaker implantation
Opposing wall motion delay
IntraVentricular Mechanical Dyssynchrony Parameter 2
Measured: Mid-term: 3-6 months after pacemaker implantation
systolic dyssynchrony index
Ventricular Mechanical Dyssynchrony Parameter 1
Measured: Long term: 12-15 months after pacemaker implantation
systolic dyssynchrony index
Ventricular Mechanical Dyssynchrony Parameter 1
Measured: Mid-term: 3-6 months after pacemaker implantation
QRS duration
Electrical dyssynchrony Parameter
Measured: Mid-term: 3-6 months after pacemaker implantation
QRS duration
Electrical dyssynchrony Parameter
Measured: Long term: 12-15 months after pacemaker implantation
Secondary outcomes (10)
Radial strain
Additional Ventricular Mechanical Dyssynchrony Parameter 1
Measured: Mid-term: 3-6 months after pacemaker implantation
Radial strain
Additional Ventricular Mechanical Dyssynchrony Parameter 1
Measured: Long term: 12-15 months after pacemaker implantation
Left Ventricular Ejection Fraction
Global left ventricle function parameter
Measured: Mid-term: 3-6 months after pacemaker implantation
Left Ventricular Ejection Fraction
Global left ventricle function parameter
Measured: Long term: 12-15 months after pacemaker implantation
Global longitudinal strain
Global left ventricle function parameter 2
Measured: Mid-term: 3-6 months after pacemaker implantation
Global longitudinal strain
Global left ventricle function parameter 2
Measured: Long term: 12-15 months after pacemaker implantation
Left ventricular output track velocity-time integral
Global left ventricle function parameter 3
Measured: Mid-term: 3-6 months after pacemaker implantation
Left ventricular output track velocity-time integral
Global left ventricle function parameter 3
Measured: Long term: 12-15 months after pacemaker implantation
Diastolic Filling Time
Atrioventricular Dyssynchrony Parameter
Measured: Mid-term: 3-6 months after pacemaker implantation
Diastolic Filling Time
Atrioventricular Dyssynchrony Parameter
Measured: Long term: 12-15 months after pacemaker implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start14 Dec 2020
- Primary completion30 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradyarrhythmiaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697797
- Sponsor's protocol ID
- RNN/147/20/KE
- Status last verified
- Nov 2022
- First submitted
- 14 Dec 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical and Electrical Dyssynchrony During His-Bundle Pacing (Selective and Non-selective) Versus His-Bundle Area Right Ventricular Pacing
- ClinicalTrials.gov ID
- NCT04697797
- Acronym / sponsor ID
- RNN/147/20/KE
- Conditions
- Bradyarrhythmia
- Keywords
- His Bundle Pacing, Dyssynchrony, Echocardiography, ECG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Jan 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 aim of this study is to evaluate mechanical and electrical cardiac dyssynchrony in patients with pacemakers and the right ventricular electrode implanted in His Bundle area.
Detailed description
Permanent His Bundle Pacing (HBP) is a well-known method of cardiac pacing which is increasingly used in everyday practice. After lead implantation in His Bundle area (HBA) capture of various tissues can be achieved: A. right ventricular myocardium near to HBP; B. cardiac conduction system selectively or nonselectively (with concomitant regional myocardium activation). The different excitability and refractory periods decide which tissue, myocardium or/and the conduction system is effectively paced. A lot of clinical trials revealed the advantage of HBP over apical ventricular pacing (AVP). HBP improves clinical (NYHA, quality of life, hospitalization rate) and echocardiographic (left ventricular dimension and ejection fraction) indicators of heart failure.
We are going to compare mechanical and electrical synchrony during the various type of myocardium activation: HBP (nsHBP or sHBP), RV pacing near HBA and native heart rhythm (if possible) in each patient recruited to the study. Adequate pacemaker programming will allow achieving different activations as shown above. The mechanical synchrony will be estimated by transthoracic echocardiography and the electrical one by the detailed analysis of ECG.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bradyarrhythmia and indications for de novo permanent pacemaker implantation. The decision for pacing lead placement in His Bundle is left for physician discretion. Patients after pacemaker system implantation with His Bundle successfully pacing are to be asked to participate in the study. After having written informed consent obtained patients are to be scheduled for ventricular synchrony evaluation with ECHO and ECG after 3-6 months after implant (mid-term) and after 12 months (long-term).
Key inclusion criteria (1 listed)
- all adult patients after implantation of pacemaker system with pacing lead successfully captured His Bundle (selectively or/and nonselectively)
Key exclusion criteria (2 listed)
- not willing or incapable to give written informed consent;
- previous implanted cardiac electronic device (pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy device)
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 |
|---|---|---|
| Device ProgrammingAlso: Echocardiography, ECGIntervention includes (1) pacemaker reprogramming (2) echocardiographic parameters acquisition (3) ECG recording | Other | – |
Primary outcome
Interventricular mechanical delay
Time frame: Mid-term: 3-6 months after pacemaker implantation
InterVentricular Mechanical Dyssynchrony Parameter 1
Interventricular mechanical delay
Time frame: Long term: 12-15 months after pacemaker implantation
InterVentricular Mechanical Dyssynchrony Parameter 1
Free-wall-LV-to-RV-delay
Time frame: Mid-term: 3-6 months after pacemaker implantation
InterVentricular Mechanical Dyssynchrony Parameter 2
Free-wall-LV-to-RV-delay
Time frame: Long term: 12-15 months after pacemaker implantation
InterVentricular Mechanical Dyssynchrony Parameter 2
Septal-to-posterior wall motion delay
Time frame: Mid-term: 3-6 months after pacemaker implantation
IntraVentricular Mechanical Dyssynchrony Parameter 1
Septal-to-posterior wall motion delay
Time frame: Long term: 12-15 months after pacemaker implantation
IntraVentricular Mechanical Dyssynchrony Parameter 1
Opposing wall motion delay
Time frame: Long term: 12-15 months after pacemaker implantation
IntraVentricular Mechanical Dyssynchrony Parameter 2
Opposing wall motion delay
Time frame: Mid-term: 3-6 months after pacemaker implantation
IntraVentricular Mechanical Dyssynchrony Parameter 2
systolic dyssynchrony index
Time frame: Long term: 12-15 months after pacemaker implantation
Ventricular Mechanical Dyssynchrony Parameter 1
systolic dyssynchrony index
Time frame: Mid-term: 3-6 months after pacemaker implantation
Ventricular Mechanical Dyssynchrony Parameter 1
QRS duration
Time frame: Mid-term: 3-6 months after pacemaker implantation
Electrical dyssynchrony Parameter
QRS duration
Time frame: Long term: 12-15 months after pacemaker implantation
Electrical dyssynchrony Parameter
10 secondary outcomes
Radial strain
Time frame: Mid-term: 3-6 months after pacemaker implantation
Radial strain
Time frame: Long term: 12-15 months after pacemaker implantation
Left Ventricular Ejection Fraction
Time frame: Mid-term: 3-6 months after pacemaker implantation
Left Ventricular Ejection Fraction
Time frame: Long term: 12-15 months after pacemaker implantation
Global longitudinal strain
Time frame: Mid-term: 3-6 months after pacemaker implantation
Global longitudinal strain
Time frame: Long term: 12-15 months after pacemaker implantation
Left ventricular output track velocity-time integral
Time frame: Mid-term: 3-6 months after pacemaker implantation
Left ventricular output track velocity-time integral
Time frame: Long term: 12-15 months after pacemaker implantation
Diastolic Filling Time
Time frame: Mid-term: 3-6 months after pacemaker implantation
Diastolic Filling Time
Time frame: Long term: 12-15 months after pacemaker implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 Bradyarrhythmia, run by Medical University of Lodz at 1 site in Poland.
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 2 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 3 Nov 2022. 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 Poland. 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 Krzysztof A Kaczmarek, MD, PhD (+48 42 201 43 60, krzysztof.kaczmarek@umed.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interventricular mechanical delay (time frame: Mid-term: 3-6 months after pacemaker implantation). The study lists 12 primary outcomes in all. 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 3 Nov 2022.