SIELLO Pilot Study for Comparison of Steroid Versus Non-S... | NCT01000532

Studies
SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads

NCT01000532

Sponsor

Biotronik SE & Co. KG

Status

Completed

Last Update Posted

Nov 16, 2011Estimated

Enrollment

88Actual

Phase

Not provided

Conditions

Arrhythmias, Cardiac

Interventions

SIELLO JT/T
Pacemaker therapy
BPPU JT/T

Countries

Hungary

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

Nov 2011

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

Oct 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Feb 2011Actual

First Submitted Date

Oct 21, 2009

First Submission Date that Met QC Criteria

Oct 22, 2009

First Posted Date

Oct 23, 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

Nov 15, 2011

Last Update Posted Date

Nov 16, 2011Estimated

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

This investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pacemaker therapy			Device: SIELLO JT/T Device: Pacemaker therapy Device: BPPU JT/T

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SIELLO JT/T	Device	Implantation of SIELLO and BPPU pacemaker leads	Pacemaker therapy

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

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with standard pacemaker indication who are refered to the hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Béla Merkely, Professor	Semmelweis University Heart Center, Budapest, Hungary	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Semmelweis University		Budapest			Hungary

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23913463	Derived	Kutyifa V, Zima E, Molnar L, Kuehne C, Theiss S, Herrmann G, Geller L, Merkely B. Direct comparison of steroid and non-steroid eluting small surface pacing leads: randomized, multicenter clinical trial. Cardiol J. 2013;20(4):431-8. doi: 10.5603/CJ.2013.0103.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms