Screening for Advanced Heart Failure Treatment (SEE-HF) | NCT01626404

Studies
Screening for Advanced Heart Failure Treatment (SEE-HF)

NCT01626404

Sponsor

Abbott Medical Devices

Status

Completed

Last Update Posted

Jun 24, 2022Actual

Enrollment

99Actual

Phase

Not provided

Conditions

Advanced Heart Failure
CRT and/or ICD

Interventions

Not provided

Countries

Denmark
France
Germany
Netherlands
Sweden
United Kingdom

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 2022

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

Oct 2012

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Jun 20, 2012

First Submission Date that Met QC Criteria

Jun 21, 2012

First Posted Date

Jun 22, 2012Estimated

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 23, 2022

Last Update Posted Date

Jun 24, 2022Actual

Name	Class
Thoratec Europe Ltd	INDUSTRY

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

Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients are underserved. The purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with CRT and/or ICD who are candidates for advanced heart failure treatment and obtain insights into patient and physician decisions regarding referral for advanced heart failure therapy.

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

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

99Actual

Label	Type	Description	Intervention Names
Patients enrolled		All patients enrolled in the study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients	Proportion of heart failure patients followed in outpatient clinic that are NYHA III-IV with LVEF \	12 months

Secondary Outcomes

Measure	Description	Time Frame
Reasons for non-referral	Assess physician's reasons for non-referral of patients for LVAD/transplant evaluation.	12 months
Patient's reasons	Assess patients reasons for declining LVAD/transplant as a treatment option.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CRT and or ICD device in place.
NYHA class III - IV heart failure
EF </= 40%
Patient is an out-patient
Patient is on optimal medical management as tolerated and as defined by primary care physician.
Patient has signed an informed consent for data collection.

Exclusion Criteria:

Age <18 years or >80 years
CRT device that has been implanted < 3 months prior to enrollment
Coronary revascularization within 3 months prior to enrollment
Patient only has ICD but has CRT planned
Non-cardiac disease resulting in life expectancy < 2 yrs
Patient is hospitalized or will be hospitalized at this time
Known diagnosis of dementia
Patient is currently on dialysis
Oxygen dependent lung disease
Previously or currently treated with LVAD or heart transplantation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Outpatients with CRT and/or ICD, EF \

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pooja Chatterjee	Thoratec Europe Limited	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen			Denmark
CHU of Nantes