Master Study Investigating the Guiding Catheter Selectra 3D

NCT04323670 | Completed

• 1 other identifier: BA110
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

Study investigating the guiding catheter Selectra 3D

Conditions

Pacemaker DDD

Outcome Measures

Primary Outcomes (1)

• Selectra 3D-related SADE-free rate

  Selectra 3D-related Serious adverse device effect rate

  7 days after implantation

Secondary Outcomes (4)

• Successful implantation rate

  At the day of implantation

• Appropriateness of sensing and pacing of Solia S

  12 months

• SADE-free rate of Solia S

  6 months

• SADE-free rate of Solia S

  12 months

Study Arms (1)

Selectra 3D

OTHER

Guiding catheter to position the brady lead into a untypical heart position

Device: "Selectra 3D" guiding catheter

Interventions

"Selectra 3D" guiding catheter DEVICE

His lead measurements

Selectra 3D

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (1)

CHRU de Tours

Tours, France

Location

Study Officials

• Uwais Mohamed, PhD

  The Northern Hospital, Epping, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Guiding catheter Selectra 3D

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 26, 2020
• Study Start: October 8, 2020
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: March 3, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)