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

BIO|MASTER.Amvia: Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family

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 Overview

• Status: Recruiting
• Conditions: Heart Failure; Bradycardia
• Intervention / Treatment: Device: Amvia/Solvia pacemaker family

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dörte Vossmeyer, Dr.; Phone Number: +49 30 68905 1306; Email: doerte.vossmeyer@biotronik.com
• Study Contact Backup: Name: Konstantinia Skreka, Dr.; Phone Number: +49 (0) 30 68905-2949; Email: konstantinia.skreka@biotronik.com

Study Locations

• Austria
  • Linz, Austria
    • Recruiting
    • Kepler Universitätsklinikum
    • Contact: Clemens Steinwender, Priv-Doz Dr.
• Germany
  • Essen, Germany
    • Recruiting
    • Elisabeth-Krankenhaus Essen
    • Contact: Dietmar Schmitz, Dr.
  • Mönchengladbach, Germany
    • Recruiting
    • Kliniken Maria Hilf GmbH
    • Contact: Istvan Szendey, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Amvia pacemaker or CRT-P implantation	Device: Amvia/Solvia pacemaker family; Implantation of a pacemaker or CRT-P devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SADE-free rate at 6 months	Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SADE-free rate at 12 months	Kaplan-Meier estimate of Amvia-related SADE-free rate at 12 months	12 months
CRT AutoAdapt performance	CRT AutoAdapt: different pacing percentages	12 months
CRT AutoAdapt AV delay	Mean adapted AV delay after pace/sense	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)	12 months
Auto LV VectorOpt	Time needed for threshold measurement	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)	2 months
aATP-related ADEs and SADEs	aATP-related ADEs and SADEs	12 months
Sensing performance of device-based measurements	The appropriateness of sensing performance will be assessed by calculating the percentage of appropriate sensing for all leads.	12 months
Pacing performance of device-based measurements	The appropriateness of pacing performance will be assessed by calculating the percentage of appropriate pacing for all leads.	12 months

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Istvan Szendey, Dr., Kliniken Maria Hilf GmbH

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: BA114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No