Master Study Investigating the Guiding Catheter Selectra 3D

Biotronik

Status

Completed

Conditions

Pacemaker DDD

Treatments

Device: "Selectra 3D" guiding catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT04323670

BA110

Details and patient eligibility

About

Study investigating the guiding catheter Selectra 3D

Full 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.

Enrollment

157 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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