Master Study Investigating the Guiding Catheter Selectra 3D

BIO|MASTER.Selectra 3D Study

Study investigating the guiding catheter Selectra 3D

Study Overview

• Status: Completed
• Conditions: Pacemaker DDD
• Intervention / Treatment: Device: "Selectra 3D" guiding catheter

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 Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France
    • CHRU De Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Selectra 3D; Guiding catheter to position the brady lead into a untypical heart position	Device: "Selectra 3D" guiding catheter; His lead measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Selectra 3D-related SADE-free rate	Selectra 3D-related Serious adverse device effect rate	7 days after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful implantation rate	Assessment, if the pacemaker lead is positioned successfully in the intended target position	At the day of implantation
Appropriateness of sensing and pacing of Solia S	Investigator assessment for leads in His position	12 months
SADE-free rate of Solia S	Safety of Solia S in His position	6 months
SADE-free rate of Solia S	Safety of Solia S in His position	12 months

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Uwais Mohamed, PhD, The Northern Hospital, Epping, Australia

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): December 22, 2022

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BA110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No