Back to resultsPost Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
Primary Purpose
Bradycardia, Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Amvia/Solvia pacemaker family
Sponsored by
About this trial
This is an interventional treatment trial for Bradycardia
Eligibility Criteria
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
Sites / Locations
- Kepler UniversitätsklinikumRecruiting
- Elisabeth-Krankenhaus EssenRecruiting
- Kliniken Maria Hilf GmbHRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Amvia pacemaker or CRT-P implantation
Arm Description
Outcomes
Primary Outcome Measures
SADE-free rate at 6 months
Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months
Secondary Outcome Measures
SADE-free rate at 12 months
Kaplan-Meier estimate of Amvia-related SADE-free rate at 12 months
CRT AutoAdapt performance
CRT AutoAdapt: different pacing percentages
CRT AutoAdapt AV delay
Mean adapted AV delay after pace/sense
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)
Auto LV VectorOpt
Time needed for threshold measurement
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)
aATP-related ADEs and SADEs
aATP-related ADEs and SADEs
Sensing performance of device-based measurements
The appropriateness of sensing performance will be assessed by calculating the percentage of appropriate sensing for all leads.
Pacing performance of device-based measurements
The appropriateness of pacing performance will be assessed by calculating the percentage of appropriate pacing for all leads.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06018818
Brief Title
Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
Official Title
BIO|MASTER.Amvia: Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Amvia pacemaker or CRT-P implantation
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Amvia/Solvia pacemaker family
Intervention Description
Implantation of a pacemaker or CRT-P devices
Primary Outcome Measure Information:
Title
SADE-free rate at 6 months
Description
Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
SADE-free rate at 12 months
Description
Kaplan-Meier estimate of Amvia-related SADE-free rate at 12 months
Time Frame
12 months
Title
CRT AutoAdapt performance
Description
CRT AutoAdapt: different pacing percentages
Time Frame
12 months
Title
CRT AutoAdapt AV delay
Description
Mean adapted AV delay after pace/sense
Time Frame
12 months
Title
Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator
Description
Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)
Time Frame
12 months
Title
Auto LV VectorOpt
Description
Time needed for threshold measurement
Time Frame
12 months
Title
Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator
Description
Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)
Time Frame
2 months
Title
aATP-related ADEs and SADEs
Description
aATP-related ADEs and SADEs
Time Frame
12 months
Title
Sensing performance of device-based measurements
Description
The appropriateness of sensing performance will be assessed by calculating the percentage of appropriate sensing for all leads.
Time Frame
12 months
Title
Pacing performance of device-based measurements
Description
The appropriateness of pacing performance will be assessed by calculating the percentage of appropriate pacing for all leads.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dörte Vossmeyer, Dr.
Phone
+49 30 68905 1306
Email
doerte.vossmeyer@biotronik.com
First Name & Middle Initial & Last Name or Official Title & Degree
Konstantinia Skreka, Dr.
Phone
+49 (0) 30 68905-2949
Email
konstantinia.skreka@biotronik.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Istvan Szendey, Dr.
Organizational Affiliation
Kliniken Maria Hilf GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kepler Universitätsklinikum
City
Linz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clemens Steinwender, Priv-Doz Dr.
Facility Name
Elisabeth-Krankenhaus Essen
City
Essen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dietmar Schmitz, Dr.
Facility Name
Kliniken Maria Hilf GmbH
City
Mönchengladbach
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Istvan Szendey, Dr.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
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