Master Study for the Investigation of Safety and Efficacy... | NCT00943046

Studies
Master Study for the Investigation of Safety and Efficacy of the SIELLO Pacemaker Leads

NCT00943046

Sponsor

Biotronik SE & Co. KG

Status

Completed

Last Update Posted

Jul 26, 2019Actual

Enrollment

164Actual

Phase

Not Applicable

Conditions

Cardiac Pacemaker Syndrome

Interventions

Pacemaker therapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jul 14, 2009

First Submission Date that Met QC Criteria

Jul 20, 2009

First Posted Date

Jul 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2019

Last Update Posted Date

Jul 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.

Detailed Description

The assessment of the safety of SIELLO pacemaker leads is based on the collection of complications which are related to the leads. The assessment of efficacy of the SIELLO pacemaker leads is based on the collection of standard electrical lead data during the implant and follow-up procedures. Subsequent to the implantation of the SIELLO leads,five follow-up visits have been scheduled: at pre-discharge and after 1, 3, 6 and 12 months.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

164Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Siello pacemaker lead	Experimental	Patients with Siello Pacemaker lead	Device: Pacemaker therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pacemaker therapy	Device	Implantation of the SIELLO pacemaker leads	Siello pacemaker lead

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complication free rate of all SIELLO leads		3 month follow-up visits
Ventricular threshold of SIELLO T (passive fixation)		3 month follow-up visits
Atrial threshold of SIELLO S (active fixation)		3 month follow-up visits

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meet the indications for pacemaker therapy
Understand the nature of the procedure
Give informed consent
Able to complete all testing required by the clinical protocol
Available for follow-up visits on a regular basis at the investigational site

Exclusion Criteria:

Meet none of the pacemaker indications
Meet one or more of the contraindications
Have a life expectancy of less than six months
Cardiac surgery in the next six months -Enrolled in another cardiac clinical investigation- Have other medical devices that may interact with the implanted pacemaker

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anselm Schaumann, Dr.	n.k.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allgemeines Krankenhaus Hamburg Altona		Hamburg		22763	Germany