Monitoring of Syncopes and/or Sustained Palpitations of S... | NCT02253134

Studies
Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)

NCT02253134

Sponsor

LivaNova

Status

Completed

Last Update Posted

Oct 1, 2014Estimated

Enrollment

395Actual

Phase

Not provided

Conditions

Syncope
Palpitations

Interventions

Not provided

Countries

Belgium
Italy
Portugal
Spain
Switzerland

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

Sep 2014

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

Aug 2010

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jul 10, 2013

First Submission Date that Met QC Criteria

Sep 30, 2014

First Posted Date

Oct 1, 2014Estimated

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

Sep 30, 2014

Last Update Posted Date

Oct 1, 2014Estimated

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 purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment) of an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of suspected arrhythmic origin, within 30 days before enrollment.

Detailed Description

Diagnostic yield (primary outcome) definition = Number of patients with conclusive diagnosis (as per investigators' decision) over the total number of patients

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

395Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the mean value of the diagnostic yield in one month	number of pts with a conclusive diagnosis (per investigators' decision) over the total number of patients	1 month

Secondary Outcomes

Measure	Description	Time Frame
Diagnostic yield of the ELR stratified by each kind of diagnosed event, by week and by event occurred post enrollment		1 month
Recurrence rate stratified by syncope /palpitation, by week and by type of events occurred post enrollment		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Syncope and/or palpitations events occurred in the last 30 days
Events likely of arrhythmic origin
No conclusive diagnosis established yet
High probability of episodes recurrence (presence of at least one previous event in the last 12 months)
Patient has signed the consent to participate to the study and/or to data treatment

Exclusion Criteria:

Inability to understand the purpose of the study or refusal to cooperate
Expected low compliance with the recording technique.
Logistical impossibility to deliver the ELR within 30 days after the index event (or after discharge from ER and/or hospitalization and/or clinic visit)
Already included in other competitor clinical study
Under guardianship
Age less than 18

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 that present unexplained Syncope and/or palpitations events of a suspected arrhythmic origin

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emanuela T Locati	Azienda Ospedaliera Niguarda Ca' Granda - Milano	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Gasthuisberg Leuven		Leuven		3000	Belgium
Az. Sanit. Locale N. 4 Chiavarese

Condition Browse Module

MeSH Terms

ID	Term
D013575	Syncope

Ancestor Terms

ID	Term
D014474	Unconsciousness
D003244	Consciousness Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided