Detection of Phrenic Nerve Stimulation Using Sensors' Sig... | NCT01233323

Studies
Detection of Phrenic Nerve Stimulation Using Sensors' Signals

NCT01233323

Sponsor

Boston Scientific Corporation

Status

Completed

Last Update Posted

Feb 3, 2017Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Heart Failure

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

Feb 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

Feb 2010

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Nov 2, 2010

First Submission Date that Met QC Criteria

Nov 2, 2010

First Posted Date

Nov 3, 2010Estimated

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

Feb 2, 2017

Last Update Posted Date

Feb 3, 2017Estimated

Description Module

Brief Summary

The purpose of this study is to collect sensor data from patients with implanted cardiac resynchronization devices who exhibit phrenic nerve stimulation.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All study patients (single arm study)		All eligible patients will be included in the only study arm and will undergo study testing.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Data collection	Collect sensor data in patients with implanted CRT-D devices who exhibit phrenic nerve stimulation.	3 months follow up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willing and capable of providing informed consent and of participating in all testing
Age 18 or above or of legal age to give informed consent specific to national law
Implanted with a Boston Scientific COGNIS™ family device
Geographically stable and is available for follow-up procedures at a study centre

Exclusion Criteria:

Patients that are pacemaker-dependent
Women who are pregnant or plan to become pregnant during the study (method of assessment upon physician's discretion)
Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry
Patients who are not expected to support approximately 30 minutes of study testing procedures
Patients who are not mentally competent enough to provide feedback on PS during study procedures

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 implanted with a COGNIS™ CRT-D device

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Glikson, MD	Heart Institute, Sheba Medical Center, Tel Hashomer, Israël	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deutsches Herzzentrum Berlin		Berlin			Germany

ID	Term
D006333	Heart Failure
D006331	Heart Diseases