Lumax 740 Master Study | NCT01454050

Studies
Lumax 740 Master Study

NCT01454050

Sponsor

Biotronik SE & Co. KG

Status

Completed

Last Update Posted

Nov 28, 2012Estimated

Enrollment

189Actual

Phase

Not provided

Conditions

Safety and Efficacy of the Lumax 740 ICD Family

Interventions

Not provided

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

Nov 2012

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

Nov 2011

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Oct 14, 2011

First Submission Date that Met QC Criteria

Oct 17, 2011

First Posted Date

Oct 18, 2011Estimated

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 27, 2012

Last Update Posted Date

Nov 28, 2012Estimated

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 Lumax 740 ICD family. Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which automatically measures the RV/LV threshold and subsequently adjusts the pacing output.

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

189Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of the automatic Capture Control feature		PHD, 1-, 3- and 6-month follow-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion Criteria: Standard indication for single, dual, or triple chamber ICD.
- Legal capacity and ability to consent
- Signed patient informed consent

In addition for HF-T devices:

Bipolar LV-lead with a min. distance of 15 mm between tip and ring
True bipolar RV lead

Exclusion Criteria:

Standard contraindication for single, dual, or triple chamber ICD.
- Age < 18 years
- Pregnant or breast-feeding woman
- Cardiac surgery planned within the next 6 months
- Life expectancy of less than 6 months
- Participating in any other clinical study of an investigational cardiac drug or device

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 ICD indication who are referred to the hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gunnar Klein, Prof. Dr.	Herz im Zentrum Hannover, Germany	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical School Hannover		Hanover		30625	Germany