Risk of Syncopal Relapses in Patients Treated With Perman... | NCT04229589

Studies
Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope

NCT04229589

Sponsor

Azienda Ospedaliera Cardinale G. Panico

Status

Unknown status

Last Update Posted

Jan 18, 2020Actual

Enrollment

1,364Actual

Phase

Not provided

Conditions

Syncope

Interventions

Clinic follow-up

Countries

Italy

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 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Mar 1, 2020Estimated

Completion Date

May 1, 2020Estimated

First Submitted Date

Jan 12, 2020

First Submission Date that Met QC Criteria

Jan 12, 2020

First Posted Date

Jan 18, 2020Actual

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

Jan 12, 2020

Last Update Posted Date

Jan 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope.

Detailed Description

Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope. All consecutive patients aged ≥18 years who underwent pacemaker implantation for syncope of bradyarrhythmic aetiology (proven or presumed) at participating centers from January 2010 to December 2013 were enrolled in the registry. During follow-up the occurrence of the first syncopal relapse after pacemaker implantation is recorded.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

7 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,364Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study population		Consecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope	Other: Clinic follow-up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clinic follow-up	Other	Patients are regularly evaluated to asses the occurrence of syncopal relapses	Study population

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Syncopal relapse	First syncopal relapse after pacemaker implantation	march 2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing pacemaker implantation for bradyarrhythmic syncope

Exclusion Criteria:

age <18 years

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

Consecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope (proven or presumed) according current guidelines

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
"Card. G. Panico" Hospital		Tricase	Lecce	73039	Italy
Federico Guerra

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

Condition Browse Module

MeSH Terms

ID	Term
D013575	Syncope
D001919	Bradycardia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided