N/A
N=130
Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead
Heart Failure · Tachyarrhythmia
Bottom Line
View on ClinicalTrials.gov: NCT03891329 ↗Enrolled (actual)
130
Serious AEs
41.5%
Results posted
Sep 2024
Primary outcome: Primary: Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up — 122 Participants — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acticor/Rivacor ICDs/CRT-Ds (Device); Plexa S DX (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biotronik SE & Co. KG
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up |
122 | 0.05 |
| SECONDARY Kaplan-Meier Estimate for the Cor Family Related SADE-free Rate |
99.2; 99.2 | — |
| SECONDARY Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator |
21; 27; 3; 1; 0 | — |
| SECONDARY Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator |
7; 10; 3; 0; 0 | — |
Summary
Post-Market Clinical Follow-up of the new Cor Family ICDs/CRT-Ds (Acticor, Rivacor) and the new Plexa ProMRI S DX right ventricular lead to provide post-market data and supporting evidence for the clinical safety and performance of the devices.
Eligibility Criteria
Inclusion Criteria
- Standard indication for ICD or CRT-D therapy according to clinical guidelines
- Planned for de novo implantation of an ICD/CRT-D, or upgrade/exchange from existing ICD/CRT-D or pacemaker implant
- Able to understand the nature of study and to provide written informed consent
- Willing and able to perform all follow-up visits at the study site
- Willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept
Exclusion Criteria
- Contraindication to ICD and CRT-D therapy
- Planned for implantation of a CRT-DX system
- For VR-T DX devices: permanent atrial tachyarrhythmia
- For VR-T DX devices: patients requiring atrial pacing
- Less than 18 years old
- Pregnant or breast feeding
- Participating in another interventional clinical investigation
- Life-expectancy is less than 12 months
- Cardiac surgical procedure planned within 12 months after implantation (including interventional procedures like ablation, valve replacement, heart transplant etc.). Procedures to occur during or prior to implantation are not exclusionary
Data sourced from ClinicalTrials.gov (NCT03891329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.