Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family

Recruiting

Conditions: Bradyardia
slow heart rate
10007521

Registration Number: NL-OMON56135

Lead Sponsor: BIOTRONIK SE and Co.KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Standard Indication for de novo, upgrade or replacement pacemaker or cardiac
resynchronization therapy pacemaker (CRT-P) implantation.
Ability and willingness to use the CardioMessenger and acceptance of the
BIOTRONIK Home Monitoring® concept.

Exclusion Criteria

Planned for the usage of conduction system pacing
Planned cardiac surgical procedures or interventional measures other than the
study procedure within the next 12 months.
Age less than 18 years

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study objective is to collect clinical data on the performance and<br /><br>safety of the Amvia pacemaker by analyzing the SADE-d (i.e. SADE related to the<br /><br>device) free rate of the Amvia pacemakers at 6 months after implantation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The main secondary objective is to confirm the clinical safety by analyzing the<br /><br>Amvia pacemaker related SADE-d events occurring during a period of 12 months<br /><br>after the implantation. Other secondary endpoints are the assessment of the<br /><br>available device algorithms and device measurements. For a complete overview on<br /><br>the endpoints see CIP section 8.1.3: endpoints.</p><br>