Master Study Investigating the Guiding Catheter Selectra 3D

Pacemaker DDD Clinical Trial

Official title:

BIO|MASTER.Selectra 3D Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04323670
• Other study ID #: BA110
• Status: Completed
• Phase: N/A
• Start date: October 8, 2020
• Est. completion date: December 22, 2022

Study information

• Verified date: May 2022
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study investigating the guiding catheter Selectra 3D

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pacemaker DDD

Intervention

Device:
• "Selectra 3D" guiding catheter
His lead measurements

Locations

Country	Name	City	State
France	CHRU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Selectra 3D-related SADE-free rate	Selectra 3D-related Serious adverse device effect rate	7 days after implantation
Secondary	Successful implantation rate	Assessment, if the pacemaker lead is positioned successfully in the intended target position	At the day of implantation
Secondary	Appropriateness of sensing and pacing of Solia S	Investigator assessment for leads in His position	12 months
Secondary	SADE-free rate of Solia S	Safety of Solia S in His position	6 months
Secondary	SADE-free rate of Solia S	Safety of Solia S in His position	12 months