Reduction or Extension of COnduction Time With Ventricula... | NCT04397224

Studies
Reduction or Extension of COnduction Time With Ventricular Electromechanical Remodeling (RECOVER)

NCT04397224

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Jun 30, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Heart Failure

Interventions

Device interrogation

Countries

South Korea

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

Jun 2021

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

Jul 20, 2018Actual

Primary Completion Date

Jul 20, 2022Estimated

Completion Date

Jul 20, 2024Estimated

First Submitted Date

May 17, 2020

First Submission Date that Met QC Criteria

May 17, 2020

First Posted Date

May 21, 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

Jun 29, 2021

Last Update Posted Date

Jun 30, 2021Actual

Name	Class
Abbott Medical Devices	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This prospective multicenter registry study aims to detect the serial changes in ventriculo-ventricular conduction times according to cardiac-resynchronization therapy response.

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

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CRT responder			Diagnostic Test: Device interrogation
CRT non-responder			Diagnostic Test: Device interrogation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Device interrogation	Diagnostic Test	Ventriculo-ventricular conduction time measurement using device analyzer	CRT non-responder CRT responder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serial change of ventriculo-ventricular conduction times	Reduction or extension of ventriculo-ventricular conduction times	from enrollment to last follow-up (2 years)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

meeting the current ESC or ACCF/AHA/HRS Class I or Class IIa indications for cardiac-resynchronization (CRT) implant

Exclusion Criteria:

Myocardial infarction, unstable angina within 40 days prior the enrollment
Recent cardiac revascularization in the 4 weeks prior to the enrollment or planned for the 3 months following
Cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the 3 months prior to the enrollment
Primary valvular disease requiring surgical correction
Pregnant or are planning during the duration of the investigation
Status 1 candidate for cardiac transplantation or consideration for transplantation over the next 12 months
Post-cardiac transplantation
Life expectancy < 12 months
Currently participating in any other clinical investigation except for observational registry

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Heart failure patients implanted with multipoint pacing CRT device and quadripolar left ventricular lead from Abbott

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Seung-Jung Park	Contact	+82-2-3410-7145		orthovics@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sejong General Hospital	Recruiting	Bucheon-si			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases