Clinical trial NCT04323670: Master Study Investigating the Guiding Catheter Selectra 3D
Official title: BIO|MASTER.Selectra 3D Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pacemaker DDD
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2020-03-26
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Guiding catheter Selectra 3D
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Selectra 3D-related SADE-free rate
timeFrame: 7 days after implantation
Secondary outcomes:
measure: Successful implantation rate
timeFrame: At the day of implantation
measure: Appropriateness of sensing and pacing of Solia S
timeFrame: 12 months
measure: SADE-free rate of Solia S
timeFrame: 6 months
measure: SADE-free rate of Solia S
timeFrame: 12 months
Other outcomes:
Locations:
city: Tours
country: France
facility: CHRU de Tours
Study officials:
affiliation: The Northern Hospital, Epping, Australia
name: Uwais Mohamed, PhD
role: PRINCIPAL_INVESTIGATOR
References: