Impact of Ventricular Pacing in Unselected ICD/CRT-D Pati... | NCT01169896

Studies
Impact of Ventricular Pacing in Unselected ICD/CRT-D Patients

NCT01169896

Sponsor

LivaNova

Status

Completed

Last Update Posted

Dec 3, 2015Estimated

Enrollment

616Actual

Phase

Not provided

Conditions

Ventricular Tachycardia
Ventricular Fibrillation

Interventions

Not provided

Countries

France

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

Dec 2015

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 2007

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jul 22, 2010

First Submission Date that Met QC Criteria

Jul 23, 2010

First Posted Date

Jul 26, 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

Dec 2, 2015

Last Update Posted Date

Dec 3, 2015Estimated

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

Observational study is evaluating Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) thérapies as a function of ventricular pacing

Detailed Description

This protocol consists in a non-interventional multi-centre, prospective study. The observational study will also answer the question of the impact of ventricular pacing on the outcome of patients implanted with ICD & CRT-D devices and how the ICD & CRT-D devices are used in clinical practice through two years follow-up.

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

616Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VT/VF episodes according to ventricular pacing (> and <50%)	Device-based data	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Main inclusion Criteria:

•Patient implanted (primo implantation or replacement) with an ICD (OVATIO VR 6250, DR 6550, CRT 6750 models, or any similar or higher range device, that includes specific diagnostic and therapeutic functionalities, mandatory to make homogeneous the collection of data)

Main exclusion Criteria:

Presence of a contra-indication to the ICD therapy.
Life expectancy less than 12 months.

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

unselected ICD/CRT-D implanted patients

Sampling Method

Probability Sample

Name	Affiliation	Role
Olivier Piot, MD	CCN St Denis	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D017180	Tachycardia, Ventricular
D014693	Ventricular Fibrillation

Ancestor Terms

ID	Term
D013610	Tachycardia
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided