Post Market Clinical Follow-up Study for the Pamira ICD Lead Family
- Conditions
- Heart FailureTachyarrhythmia
- Interventions
- Device: Pamira ICD lead family
- Registration Number
- NCT05621187
- Lead Sponsor
- Biotronik SE & Co. KG
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All patients Pamira ICD lead family -
- Primary Outcome Measures
Name Time Method Pamira lead related SADE-d free rate at 6 months after implantation 6 months
- Secondary Outcome Measures
Name Time Method 2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up 6 months, 12 months 3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up 6 months, 12 months 1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation 3 months, 12 months
Trial Locations
- Locations (23)
Assuta Medical Center
🇮🇱Ashdod, Israel
UZ Brussels
🇧🇪Jette, Belgium
State Hospital of Cardiology
🇭🇺Balatonfüred, Hungary
Semmelweis University
🇭🇺Budapest, Hungary
Immanuel Klinikum Bernau Herzzentrum Brandenburg
🇩🇪Bernau, Brandenburg, Germany
Shaare Zedek MC
🇮🇱Jerusalem, Israel
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
UZ Leuven Gasthuisberg
🇧🇪Leuven, Belgium
Medizinische Universität Graz
🇦🇹Graz, Steiermark, Austria
John Hunter Hospital
🇦🇺New Lambton Heights, New South Wales, Australia
Universitätsklinikum Erlangen
🇩🇪Erlangen, Bayern, Germany
Klinikum der Universität München
🇩🇪München, Bayern, Germany
St. Marienkrankhaus Klinikum Westmünsterland GmbH
🇩🇪Ahaus, Nordrhein-Westfalen, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Bayern, Germany
Otto-von-Guericke-Universität Magdeburg
🇩🇪Magdeburg, Sachsen-Anhalt, Germany
Klinikum Dorothea Christiane Erxleben Quedlinburg
🇩🇪Quedlinburg, Sachsen-Anhalt, Germany
Städtisches Klinikum Dresden-Friedrichstadt
🇩🇪Dresden, Sachsen, Germany
SRH Zentralklinikum Suhl GmbH
🇩🇪Suhl, Thüringen, Germany
Städtisches Klinikum Brandenburg GmbH
🇩🇪Brandenburg, Germany
SRH Wald-Klinikum Gera GmbH
🇩🇪Gera, Thüringen, Germany
The University of Pécs
🇭🇺Pécs, Hungary
Soroka Medical Center
🇮🇱Beer-Sheva, Israel
Stredoslovenský ústav srdcových a cievnych chorôb, a.s. (SÚSCCH, a.s.)
🇸🇰Banská Bystrica, Slovakia