Pacemaker Indication
Conditions
Brief summary
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.
Interventions
DEVICEEVIA Pacemaker
patient has standard indication for pacemaker therapy
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Meet the indications for pacemaker therapy * Understand the nature of the procedure * Give informed consent * Able to complete all testing required by the clinical protocol * Available for follow-up visits on a regular basis at the investigational site
Exclusion criteria
* Meet none of the pacemaker indications * Meet one or more of the contraindications * Patients with chronic atrial fibrillation (dual chamber pacemaker only) * Have a life expectancy of less than six months * Cardiac surgery in the next six months * Enrolled in another cardiac clinical investigation * Have other medical devices that may interact with the implanted pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement) | 1 month follow-up completed | atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude. atrial threshold test: measurable automatically or manually. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication Free Rate | 1- and 3- month follow-up completed | Complication free rate (in %): 1 minus(the number of possibly pacemaker related complications divided by the number of patients) |
Countries
France
Participant flow
Recruitment details
In this study the data of n = 175 patients from 34 clinical sites in Austria, Denmark, France, Germany, Spain, Sweden and United Kingdom are included. The period of investigation covered was between June 04, 2009 (day of first implant) and February 26, 2010 (day of last follow-up).
Participants by arm
| Arm | Count |
|---|---|
| Pacemaker Therapy Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T) | 175 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Drop-out | 5 |
| Overall Study | ICD upgrade | 1 |
Baseline characteristics
| Characteristic | Pacemaker Therapy |
|---|---|
| Age Continuous | 74 years STANDARD_DEVIATION 10.5 |
| Age, Customized Between 34 and 93 years | 175 participants |
| Region of Enrollment Austria | 32 participants |
| Region of Enrollment Denmark | 19 participants |
| Region of Enrollment France | 9 participants |
| Region of Enrollment Germany | 93 participants |
| Region of Enrollment Spain | 16 participants |
| Region of Enrollment Sweden | 4 participants |
| Region of Enrollment United Kingdom | 2 participants |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 28 / 175 |
| serious Total, serious adverse events | 52 / 175 |
Outcome results
Primary
Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement)
atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude. atrial threshold test: measurable automatically or manually.
Time frame: 1 month follow-up completed
Population: At 1 month follow-up 93 patients with dual chamber pacemaker had both manual and automatic atrial treshold tests (ITT analysis).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pacemaker Therapy | Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement) | -0.01 Volt |
Secondary
Complication Free Rate
Complication free rate (in %): 1 minus(the number of possibly pacemaker related complications divided by the number of patients)
Time frame: 1- and 3- month follow-up completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pacemaker Therapy | Complication Free Rate | 99 Percentage complication free patients |