MultipOlar Left Ventricular Electrode Instability Trial | NCT03857516

Studies
MultipOlar Left Ventricular Electrode Instability Trial

NCT03857516

Sponsor

Deutsches Herzzentrum Muenchen

Status

Unknown status

Last Update Posted

Feb 28, 2019Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Pacemaker Electrode Lead Displacement

Interventions

Multipolar left ventricular lead implantation

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 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Jul 31, 2019Estimated

Completion Date

Aug 31, 2019Estimated

First Submitted Date

Feb 26, 2019

First Submission Date that Met QC Criteria

Feb 26, 2019

First Posted Date

Feb 28, 2019Actual

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 26, 2019

Last Update Posted Date

Feb 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Characterization of pacing thresholds in available pacing vectors of quadripolar leads used for cardiac resynchronization therapy in a short term follow-up.

Detailed Description

Multipolar left ventricular leads are increasingly used in cardiac resynchronization therapy. Lead dislodgment requiring re-intervention is rare. However, data on minor lead movements which may affect pacing capabilities and application of new pacing algorithms is scarce. Aim of the study is to characterize pacing thresholds of each of the implanted electrodes on quadripolar leads in a short term follow-up.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Recipients of cardiac resynchronization therapy		Consecutive patients with de novo implantation of a cardiac resynchronization defibrillator or pacemaker.	Device: Multipolar left ventricular lead implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multipolar left ventricular lead implantation	Device	Multipolar left ventricular lead implantation with measurements of pacing thresholds in varrious pacing configurations.	Recipients of cardiac resynchronization therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Microdislodgement of leads	Change of pacing threshold	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

De novo implantation of left ventricular multipolar leads.

Exclusion Criteria:

Cardiogenic shock
Device infection
Revision for previously dislodged left ventricular lead
Age below 18 years
Pregnancy
Patients under tutelage

Accepts Healthy Volunteers

Not provided

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 receiving cardiac resynchronization therapy according to guidelines with the implantation of a multipolar left ventricular lead.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Severin Weigand, MD	Contact	0049891218	2020	weigand@dhm.mhn.de
Christof Kolb, MD	Contact	0049891218	2020	kolb@dhm.mhn.de

Overall Officials

Name	Affiliation	Role
Christof Kolb, MD	Deutsches Herzzentrum Muenchen	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deutsches herzzentrum Muenchen	Recruiting	Munich	Bavaria	80636	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided