Bradycardia, Heart Failure
Conditions
Keywords
Cardiac pacemaker, CRT-P
Brief summary
The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation. The study will be conducted at sites in Australia and New Zealand. It is planned to include 50 subjects in the study. Participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits. At the visits the device will be interrogated and standard device measurements including those related to special features will be performed to assess the functionality of the device. Programming of the pacemakers will be done according to the participant´s therapeutical needs.
Interventions
DEVICEAmvia Sky pacemaker or CRT-P device
Subjects with an indication for a pacemaker or CRT-P device will be implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. Device programming will be done according to the medical needs of the subjects.
Sponsors
Biotronik SE & Co. KG
Biotronik Australia Pty Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Standard indication for pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation, including de novo, upgrade or replacement implantations * Ability to understand the nature of the study * Willingness to provide written informed consent * Ability and willingness to perform all follow-up visits at the study site * Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept
Exclusion criteria
* Planned for conduction system pacing * Planned for activation of atrial anti-tachycardia pacing (aATP) without known history of atrial arrhythmia, or with permanent atrial fibrillation (AF) * Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months * Pregnant or breast feeding * Age less than 18 years * Participation in another interventional clinical investigation according to the definition given in the study protocol * Life-expectancy less than 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Device Effect (SADE)-Free Rate After 12 Months | 12 months | Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate |
Other
| Measure | Time frame | Description |
|---|---|---|
| Right Atrial Sensing Amplitude | 12 months | The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed in the right atrium. |
| Right Atrial Pacing Threshold | 12 months | The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed in the right atrium. |
| Right Ventricular Sensing Amplitude | 12 months | The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed in the right ventricle. |
| Right Ventricular Pacing Threshold | 12 months | The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed in the right ventricle. |
| Left Ventricular Sensing Amplitude | 12 months | The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed next to the left ventricle. |
| Left Ventricular Pacing Threshold | 12 months | The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed next to the left ventricle. |
Countries
Australia, New Zealand
Participant flow
Recruitment details
52 patients were enrolled between the date of first patient in (November 23, 2022) and last patient in (May 25, 2023). Patients that were already enrolled at the time of the notification of enrollment stop (after the 50th implantation) were still admitted for implantation, thus leading to two more patients than specified in the protocol (N=50)l.
Pre-assignment details
50 patients were planned to be enrolled according to the protocol. At the time of the notification of enrollment stop (after the 50th implantation), two additional patients were already enrolled, thus leading to a total of 52 enrolled patients. All enrolled patients provided written informed consent and were implanted with an investigational device.
Participants by arm
| Arm | Count |
|---|---|
| Amvia Sky Pacemaker or CRT-P Implantation Patients implanted with an Amvia Sky pacemaker or CRT-P device
Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine. | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 6 |
Baseline characteristics
| Characteristic | Amvia Sky Pacemaker or CRT-P Implantation |
|---|---|
| Age, Continuous | 75.2 years STANDARD_DEVIATION 9.6 |
| Race/Ethnicity, Customized Ethnicity Asian | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Black | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasion | 49 Participants |
| Race/Ethnicity, Customized Ethnicity Indigenous | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 1 Participants |
| Region of Enrollment Australia | 36 participants |
| Region of Enrollment New Zealand | 16 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 52 |
| other Total, other adverse events | 27 / 52 |
| serious Total, serious adverse events | 30 / 52 |
Outcome results
Primary
Serious Adverse Device Effect (SADE)-Free Rate After 12 Months
Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate
Time frame: 12 months
Population: All 52 patients implanted with an investigational device contribute to the analysis of the SADE-free rate.~Neither any of the 46 patients with regular study termination after 12 months, nor any of the 6 patients with premature study termination had any SADE.~Thus, a 95% CI for the SADE-free rate could methodologically not be estimated with the Kaplan-Meier method, but instead with the binomial method.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Amvia Sky Pacemaker or CRT-P Implantation | Serious Adverse Device Effect (SADE)-Free Rate After 12 Months | 52 Participants |
Other Pre-specified
Left Ventricular Pacing Threshold
The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed next to the left ventricle.
Time frame: 12 months
Population: The analysis population for left ventricular lead parameters consists of those patients that were implanted with an LV lead, i.e. patients with a triple-chamber device, and for whom a value was measured at the specified timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amvia Sky Pacemaker or CRT-P Implantation | Left Ventricular Pacing Threshold | 1.4 V | Standard Deviation 0.5 |
Other Pre-specified
Left Ventricular Sensing Amplitude
The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed next to the left ventricle.
Time frame: 12 months
Population: The analysis population for left ventricular lead parameters consists of those patients that were implanted with an LV lead, i.e. patients with a triple-chamber device, and for whom a value was measured at the specified timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amvia Sky Pacemaker or CRT-P Implantation | Left Ventricular Sensing Amplitude | 11.5 mV | Standard Deviation 6 |
Other Pre-specified
Right Atrial Pacing Threshold
The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed in the right atrium.
Time frame: 12 months
Population: The analysis population for right atrial lead parameters consists of those patients that were implanted with an atrial lead, i.e. patients with a dual- or triple-chamber device, and for whom a value was measured at the specified timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amvia Sky Pacemaker or CRT-P Implantation | Right Atrial Pacing Threshold | 0.9 V | Standard Deviation 0.7 |
Other Pre-specified
Right Atrial Sensing Amplitude
The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed in the right atrium.
Time frame: 12 months
Population: The analysis population for right atrial lead parameters consists of those patients that were implanted with an atrial lead, i.e. patients with a dual- or triple-chamber device, and for whom a value was measured at the specified timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amvia Sky Pacemaker or CRT-P Implantation | Right Atrial Sensing Amplitude | 3.4 mV | Standard Deviation 1.9 |
Other Pre-specified
Right Ventricular Pacing Threshold
The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed in the right ventricle.
Time frame: 12 months
Population: The analysis population for right ventricular lead parameters consists of all patients for whom a value was measured at the specified timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amvia Sky Pacemaker or CRT-P Implantation | Right Ventricular Pacing Threshold | 0.9 V | Standard Deviation 0.3 |
Other Pre-specified
Right Ventricular Sensing Amplitude
The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed in the right ventricle.
Time frame: 12 months
Population: The analysis population for right ventricular lead parameters consists of all patients for whom a value was measured at the specified timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amvia Sky Pacemaker or CRT-P Implantation | Right Ventricular Sensing Amplitude | 10.8 mV | Standard Deviation 3.9 |