Master Study Investigating the Guiding Catheter Selectra 3D

Not Applicable

Completed

• Conditions: Pacemaker DDD
• Interventions: Device: "Selectra 3D" guiding catheter

• Registration Number: NCT04323670
• Lead Sponsor: Biotronik SE & Co. KG

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.

Study Timeline

• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-26
• Study Start: 2020-10-08
• Status Verified: 2022-05
• Primary Completion: 2022-12-22
• Study Completion: 2022-12-22
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Selectra 3D	"Selectra 3D" guiding catheter	Guiding catheter to position the brady lead into a untypical heart position

Primary Outcome Measures

Name	Time	Method
Selectra 3D-related SADE-free rate	7 days after implantation	Selectra 3D-related Serious adverse device effect rate

Secondary Outcome Measures

Name	Time	Method
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	12 months	Safety of Solia S in His position

Trial Locations

Locations (1)

CHRU de Tours; 🇫🇷 Tours, France