Cardiac Pacing in Adherence With ESC Cardiac Pacing GuidelinesNCT06782152
AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region (PREMIER LEADLESS)
An observational study of Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines, run by King Fahad Armed Forces Hospital.
Trial summary
The AVEIR™ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of AVEIR™ leadless pacemakers used in real-world clinical practice and to evaluate clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines
- How many people
- 1,698 participants
- Where
- No sites listed yet
- Study dates
- 6 Jan 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Subject clinically indicated to receive a Leadless Pacemaker in adherence with ESC cardiac pacing guidelines.
Who may be able to join
- Subject has clinical indication to cardiac pacing in adherence with ESC cardiac pacing guidelines.
- Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.
- Subject agrees to return to clinic for the study follow-up visits.
- Subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by IRB/EC.
Who cannot join
- Subject is currently participating in another study that may confound the results of this research.
- Subject has a life expectancy less than 12 months.
- Subject is pregnant or nursing or planning pregnancy during the study.
- Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with the site standard follow-up visits, for example a mechanical tricuspid
- Page 3 of 4 [DRAFT] - valve prosthesis or vein thrombosis, which could impede the delivery of implantable devices as planned by the implanters.
- Subject is allergic/hypersensitive to <1 mg dexamethasone sodium phosphate.
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- Subject is implanted with an electrically active implantable medical device with stimulation capabilities at risk to be impacted by the Aveir Link Module telemetry.
- Subject has known pacemaker syndrome, if that condition, in the investigator's opinion, represents a contraindication to the implant of the planned pacemaker.
- Subject has pacing induced cardiomyopathy.
About this study
Official title: AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region
The AVEIR™ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of AVEIR™ leadless pacemakers used in real-world clinical practice and to evaluate clinical outcomes and characteristics of patients treated with these leadless devices.
Read the detailed description
The AVEIR™ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of AVEIR™ leadless pacemakers used in real-world clinical practice and to evaluate clinical outcomes and characteristics of patients treated with these leadless devices. The study aims to evaluate safety profile, electrical performances and clinical outcomes in patients indicated for cardiac pacing after they receive Aveir LP systems. The Aveir VR LP system, for ventricular pacing, and the Aveir AR LP system for atrial pacing, and their concomitant use in the dual chamber configuration (Aveir DR LP system), have received the CE mark. The study also aims to understand clinical characteristics of patients receiving AVEIR™ leadless pacemaker devices in real-world clinical practice. The study Investigators will gather data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures are commercially available and already in use in the participating sites. The structure of this document provides a general overview and methodology of the study and a few specific details such as sample size, follow-up procedures, reporting requirements, and definitions.
- Keywords
- Bradycardia, Sick Sinus Syndrome, Pacemaker, AV Block, Vasovagal Syncope, Heart Diseases, Cardiovascular Diseases, Pathologic Proceses, Arrhytmias, Cardiac
- Medical subject headings
- Bradycardia, Sick Sinus Syndrome, Atrioventricular Block, Syncope, Vasovagal, Heart Diseases, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary safety endpoint is 1 year incidence rate of leadless device-related or procedure-related major complications. AveirTM LP systems
Major complications are defined as events related to the leadless pacing system or leadless pacing system implant procedure resulting in death, permanent loss of device function due to mechanical or electrical dysfunction, hospitalization, prolonged hospitalization by at least 48 h, or system revision AveirTM LP systems
Measured: 12 momths
Acceptable ventricular pacing thresholds and R-wave amplitudes measured at 12 months.
Ventricular pacing threshold is considered acceptable if <2.0 V at 0.4 ms and R-wave amplitude is considered acceptable if >5.0 mV or ≥ of the implant value
Measured: 12 months
Acceptable atrial pacing thresholds and P-wave amplitudes as measured at 12 months.
atrial capture threshold is considered acceptable if ≤3.0 V at 0.4 ms and atrial sensing Amplitude is considered adequate if P wave ≥1.0 mV.
Measured: 12 months
Secondary outcomes (13)
Freedom from device- or procedure-related major complications at 24 months
Major complications are defined as events related to the leadless pacing system or leadless pacing system implant procedure resulting in death, permanent loss of device function due to mechanical or electrical dysfunction, hospitalization, prolonged hospitalization by at least 48 h, or system revision.
Measured: 24 months
All adverse events, regardless device- or procedure-relatedness.
Measured: 48 months
Implant success rate and reasons for unsuccessful implant.
Measured: 24 months
Number of device repositioning at time of implantation.
Measured: 24 months
Implant duration, fluoroscopy duration, and time from implant to hospital discharge.
Measured: 24 months
Final LP placement site.
Measured: 24 months
Demographics and medical history, with specific focus on indication for pacemaker implant and reasons for the choice of leadless pacemakers.
Measured: 24 months
Device longevity, as displayed by the programmer at each visit.
Measured: 48 months
Device programming and pacing and sensing conditions which may impact longevity.
Measured: 48 months
Need for and success of device retrieval.
Measured: 48 months
Number of hospitalizations and mortality.
Measured: 48 months
Upgrade from Aveir VR to Aveir DR and from Aveir AR to Aveir DR.and Communication i2i success rate.
Measured: 48 months
Development of pacing induced cardiomyopathy
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start6 Jan 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Pacing in Adherence With ESC Cardiac Pacing GuidelinesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,698 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Fahad Armed Forces Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fayez Bokhari, King Fahad Armed Forces Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782152
- Sponsor's protocol ID
- Version A
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 17 Jan 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 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region
- ClinicalTrials.gov ID
- NCT06782152
- Acronym / sponsor ID
- Version A
- Keywords
- Bradycardia, Sick Sinus Syndrome, Pacemaker, AV Block, Vasovagal Syncope, Heart Diseases, Cardiovascular Diseases, Pathologic Proceses
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,698 participants (estimated)
- Lead sponsor
- King Fahad Armed Forces HospitalOther government
- Study start
- 6 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jan 2025 (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 AVEIR™ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of AVEIR™ leadless pacemakers used in real-world clinical practice and to evaluate clinical outcomes and characteristics of patients treated with these leadless devices.
Detailed description
The AVEIR™ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of AVEIR™ leadless pacemakers used in real-world clinical practice and to evaluate clinical outcomes and characteristics of patients treated with these leadless devices. The study aims to evaluate safety profile, electrical performances and clinical outcomes in patients indicated for cardiac pacing after they receive Aveir LP systems. The Aveir VR LP system, for ventricular pacing, and the Aveir AR LP system for atrial pacing, and their concomitant use in the dual chamber configuration (Aveir DR LP system), have received the CE mark. The study also aims to understand clinical characteristics of patients receiving AVEIR™ leadless pacemaker devices in real-world clinical practice. The study Investigators will gather data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures are commercially available and already in use in the participating sites. The structure of this document provides a general overview and methodology of the study and a few specific details such as sample size, follow-up procedures, reporting requirements, and definitions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject clinically indicated to receive a Leadless Pacemaker in adherence with ESC cardiac pacing guidelines.
Key inclusion criteria (4 listed)
- Subject has clinical indication to cardiac pacing in adherence with ESC cardiac pacing guidelines.
- Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.
- Subject agrees to return to clinic for the study follow-up visits.
- Subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by IRB/EC.
Key exclusion criteria (9 listed)
- Subject is currently participating in another study that may confound the results of this research.
- Subject has a life expectancy less than 12 months.
- Subject is pregnant or nursing or planning pregnancy during the study.
- Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with the site standard follow-up visits, for example a mechanical tricuspid
- Subject is allergic/hypersensitive to <1 mg dexamethasone sodium phosphate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary safety endpoint is 1 year incidence rate of leadless device-related or procedure-related major complications. AveirTM LP systems
Time frame: 12 momths
Major complications are defined as events related to the leadless pacing system or leadless pacing system implant procedure resulting in death, permanent loss of device function due to mechanical or electrical dysfunction, hospitalization, prolonged hospitalization by at least 48 h, or system revision AveirTM LP systems
Acceptable ventricular pacing thresholds and R-wave amplitudes measured at 12 months.
Time frame: 12 months
Ventricular pacing threshold is considered acceptable if <2.0 V at 0.4 ms and R-wave amplitude is considered acceptable if >5.0 mV or ≥ of the implant value
Acceptable atrial pacing thresholds and P-wave amplitudes as measured at 12 months.
Time frame: 12 months
atrial capture threshold is considered acceptable if ≤3.0 V at 0.4 ms and atrial sensing Amplitude is considered adequate if P wave ≥1.0 mV.
13 secondary outcomes
Freedom from device- or procedure-related major complications at 24 months
Time frame: 24 months
All adverse events, regardless device- or procedure-relatedness.
Time frame: 48 months
Implant success rate and reasons for unsuccessful implant.
Time frame: 24 months
Number of device repositioning at time of implantation.
Time frame: 24 months
Implant duration, fluoroscopy duration, and time from implant to hospital discharge.
Time frame: 24 months
Final LP placement site.
Time frame: 24 months
Demographics and medical history, with specific focus on indication for pacemaker implant and reasons for the choice of leadless pacemakers.
Time frame: 24 months
Device longevity, as displayed by the programmer at each visit.
Time frame: 48 months
Device programming and pacing and sensing conditions which may impact longevity.
Time frame: 48 months
Need for and success of device retrieval.
Time frame: 48 months
Number of hospitalizations and mortality.
Time frame: 48 months
Upgrade from Aveir VR to Aveir DR and from Aveir AR to Aveir DR.and Communication i2i success rate.
Time frame: 48 months
Development of pacing induced cardiomyopathy
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines, run by King Fahad Armed Forces Hospital.
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 9 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: opening soon, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
The primary safety endpoint is 1 year incidence rate of leadless device-related or procedure-related major complications. AveirTM LP systems (time frame: 12 momths). The study lists 3 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 17 Jan 2025.