Pacemaker DDD
Conditions
Brief summary
Study investigating the guiding catheter Selectra 3D
Detailed description
The guiding catheter 'Selectra 3D' is a catheter that is intended to support the implantation of a pacemaker lead in untypical positions in the heart like in the His- bundle area. This study is designed as post market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the guiding catheter Selectra 3D that remained unrevealed even after risk analysis, risk mitigation and successful conformity assessment. Moreover, the study aims at providing additional PMCF data, as required by regulatory authorities. Furthermore, the performance and efficacy of the Selectra 3D shall be assessed. The results will be used for updating the clinical evaluation.
Interventions
DEVICESelectra 3D guiding catheter
His lead measurements
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Guiding catheter Selectra 3D
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Standard indication for de novo pacemaker or cardiac resynchronization implantation * The patient is intended for guiding catheter based implantation of a pacemaker system * Patient is able to understand the nature of the study and has provided written informed consent * Patient is willing and able to perform all follow up visits at the study site * Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring® concept
Exclusion criteria
* AV block with no escape rhythm or broad QRS escape rhythm * Standard contraindications for use of the investigational devices: * Existing or possible occlusion of the coronary vessels or unsuitable anatomy of the coronary veins * Active systemic infection * Mechanical tricuspid valve prosthesis or severe tricuspid valve diseases * Intolerance against dexamethasone acetate * Planned cardiac surgical procedures or interventional measures in addition to the study procedure within the next 6 months * Expected to receive heart transplantation or ventricular assist device within 1 year * Patient is pregnant or breast feeding * Less than 18 years old * Participating in another interventional clinical investigation * Life-expectancy is less than 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Selectra 3D-related SADE-free rate | 7 days after implantation | Selectra 3D-related Serious adverse device effect rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful implantation rate | At the day of implantation | Assessment, if the pacemaker lead is positioned successfully in the intended target position |
| Appropriateness of sensing and pacing of Solia S | 12 months | Investigator assessment for leads in His position |
| SADE-free rate of Solia S | 6 months | Safety of Solia S in His position |
Countries
France
Outcome results
None listed