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

Biotronik SE & Co. KG129 enrolled

Overview

The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt and Early Check features in the setting of a post-market clinical follow-up study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

129

Conditions

Bradycardia Heart Failure

Interventions

Amvia/Solvia pacemaker familyDEVICE

Implantation of a pacemaker or CRT-P devices

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Standard indication for de novo, upgrade or replacement pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation * 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 cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months * Known pregnancy or breast feeding * Age less than 18 years * Participation in another interventional clinical investigation * Life-expectancy less than 12 months

Locations (3)

Kepler Universitätsklinikum

Linz, Austria

Elisabeth-Krankenhaus Essen

Essen, Germany

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany

Outcomes

Primary Outcomes

SADE-free rate at 6 months

Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months

Time frame: 6 months

Secondary Outcomes

SADE-free rate at 12 months

Kaplan-Meier estimate of Amvia-related SADE-free rate at 12 months

Time frame: 12 months

CRT AutoAdapt performance

CRT AutoAdapt: different pacing percentages

Time frame: 12 months

CRT AutoAdapt AV delay

Mean adapted AV delay after pace/sense

Time frame: 12 months

Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator

Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)

Time frame: 12 months

Auto LV VectorOpt

Time needed for threshold measurement

Time frame: 12 months

Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator

Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)

Time frame: 2 months

aATP-related ADEs and SADEs

Time frame: 12 months

Sensing performance of device-based measurements

Data from ClinicalTrials.gov

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