Back to resultsPost Market Clinical Follow-up Study for the Pamira ICD Lead Family
Primary Purpose
Heart Failure, Tachyarrhythmia
Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Pamira ICD lead family
Sponsored by
About this trial
This is an interventional other trial for Heart Failure
Eligibility Criteria
Inclusion Criteria: Standard indication for ICD or CRT-D therapy according to clinical guidelines Planned for de novo implantation of a BIOTRONIK ICD or CRT-D in combination with Pamira Ability to understand the nature of the study and 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 the BIOTRONIK Home Monitoring® concept Exclusion Criteria: Mechanical tricuspid valve prosthesis or a severe tricuspid valve disease Known Dexamethasone acetate intolerance Cardiac surgical post-implantation procedure planned within 12 months (including interventional procedures like ablation, valve replacement, heart transplant etc.) Less than 18 years old Pregnant or breast feeding Participating in another interventional clinical investigation Life-expectancy less than 12 months
Sites / Locations
- John Hunter HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All patients
Arm Description
Outcomes
Primary Outcome Measures
Pamira lead related SADE-d free rate at 6 months after implantation
Secondary Outcome Measures
1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation
2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up
3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up
Full Information
NCT ID
NCT05621187
First Posted
November 7, 2022
Last Updated
December 16, 2022
Sponsor
Biotronik SE & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT05621187
Brief Title
Post Market Clinical Follow-up Study for the Pamira ICD Lead Family
Official Title
BIO|MASTER.Pamira Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
February 28, 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
Confirm clinical safety and performance of the Pamira lead to support the regulatory post market strategy in Europe and other regions and validating promotional claims by
demonstrating clinical safety
evaluating performance based on sensing and pacing assessment
collecting additional data of interest to assess other aspects such as the handling and usability
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Tachyarrhythmia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
218 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All patients
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Pamira ICD lead family
Intervention Description
Implantation, measurements and follow-up schedule
Primary Outcome Measure Information:
Title
Pamira lead related SADE-d free rate at 6 months after implantation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation
Time Frame
3 months, 12 months
Title
2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up
Time Frame
6 months, 12 months
Title
3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up
Time Frame
6 months, 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 ICD or CRT-D therapy according to clinical guidelines
Planned for de novo implantation of a BIOTRONIK ICD or CRT-D in combination with Pamira
Ability to understand the nature of the study and 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 the BIOTRONIK Home Monitoring® concept
Exclusion Criteria:
Mechanical tricuspid valve prosthesis or a severe tricuspid valve disease
Known Dexamethasone acetate intolerance
Cardiac surgical post-implantation procedure planned within 12 months (including interventional procedures like ablation, valve replacement, heart transplant etc.)
Less than 18 years old
Pregnant or breast feeding
Participating in another interventional clinical investigation
Life-expectancy less than 12 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anja Viehrig, Dr.
Phone
+49 (0) 151 6890-1304
Email
anja.viehrig@biotronik.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ines Danzke
Phone
+49 (0) 151 6890-1352
Email
ines.danzke@biotronik.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Deneke, Prof.
Organizational Affiliation
RHÖN-KLINIKUM Campus Bad Neustadt, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
NSW 2305
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Jackson, Dr.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post Market Clinical Follow-up Study for the Pamira ICD Lead Family
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