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| ID | Type | Description | Link |
|---|---|---|---|
| Medical Affairs CR24562 | Other Grant/Funding Number | Abbott Medical UK Ltd. |
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This observational study will follow patients requiring implantation of leadless pacemaker for 5 years after implantation. The main goal is to evaluate the long term safety and efficacy of AVEIR™ leadless pacemaker device in the usual clinical settings within the UK National Health Service. In addition, the study will collect data to understand patient characteristics receiving this type of pacemaker.
AVEIR™ stimulator (Abbott) obtained the approvals in July 2023 and started to be implanted in patients in Europe. As a leadless pacemaker, the AVEIR™ Leadless Pacemaker (LP) does not need a connector, pacing lead, or pulse generator pocket. The LP is delivered percutaneously via the femoral vein through an AVEIR™ Introducer and Delivery Catheter. AVEIR™ LP is intended to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target treatment group.
The purpose of this study is to understand long term safety and performance characteristic of this device. In addition, the study will collect anonymous clinical data and characteristics of the patients chosen to be implanted with AVEIR™ leadless pacemaker in routine clinical practice in approved centres across the UK.
Six hundred patients will be recruited in up to 15 centres during 2 years recruitment period. They will be followed up for 5 years after implantation of the leadless pacemaker. Investigators will record their age, sex, medical history, indications for receiving AVEIR™ and any complications related to the implantation procedure or the device itself. All the data will be collected in an anonymous format. Patients will be followed up according to the standard of care in the national health care system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients requiring leadless pacemaker insertion | Patients who require leadless pacemaker to manage their heart condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVEIR™leadless pacemaker | Device | AVEIR™ leadless pacemaker implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients without complications related to the device or implantation procedure. | Complications arising from the procedure or the device will be recorded to evaluate the success rate of the implantation. | 5 years |
| Percentage of patients requiring re-intervention. | Replacement, explant, upgrade, or modification of the position of the device are considered re-interventions which will be used to evaluate safety of the device. | 5 years |
| Stimulation threshold (V) in the therapeutic zone | Minimum current needed to stimulate the paced chamber. | 5 years |
| Percentage of stimulation in the therapeutic zone | Percentage of paced vs non paced heart beats. | 5 years |
| Impedance (Ohm) of R waves in the therapeutic zone | Physiological measure recorded by the device. | 5 years |
| Amplitudes of R waves (mV) in the therapeutic zone | Physiological measure recorded by the device. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Age of patient (years) at AVEIR ™ leadless pacemaker implantation | Collected as part of the demographics data for the patient group under investigation. | 5 years |
| Sex of patient at AVEIR ™ leadless pacemaker implantation |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive cardiology patients listed for leadless pacemaker implantation and fitted with AVEIR™ LP device in the usual clinical practice in the UK National Health Service centres.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ines Kralj-Hans, PhD | Contact | 0330128 8854 | i.kralj-hans@rbht.nhs.uk | |
| Veronica Tudor | Contact | 0330128 8854 | v.tudor@rbht.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Tom Wong, MD | Royal Brompton and Harefield Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton Hospital | Recruiting | London | UK | SW3 6NP | United Kingdom |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D013575 | Syncope |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Collected as part of the demographics data for the patient group under investigation.
| 5 years |
| Medical history at AVEIR ™ leadless pacemaker implantation | List of significant cardiac or other comorbidities at the time of pacemaker implantation to describe patient population receiving AVEIR ™ leadless pacemaker. | 5 years |
| Indications for AVEIR ™ leadless pacemaker implantation | Collected as part of the demographics data for the patient group under investigation. | 5 years |
| The Royal Brompton Hospital | Not yet recruiting | London | United Kingdom |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |