Screening for Advanced Heart Failure Treatment (SEE-HF)

NCT ID: NCT01626404

Last Updated: 2022-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-02-29

Brief Summary

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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

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Conditions

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Advanced Heart Failure CRT and/or ICD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients enrolled

All patients enrolled in the study

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thoratec Europe Ltd

INDUSTRY

Sponsor Role collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pooja Chatterjee

Role: STUDY_DIRECTOR

Thoratec Europe Limited

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

CHU of Nantes

Nantes, , France

Site Status

Hannover Medical Center

Hanover, , Germany

Site Status

University Clinical Center Tuebingen

Tübingen, , Germany

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Karolinska University Hospital

Stockholm, , Sweden

Site Status

University Hospital of South Manchester NHS Trust

Manchester, , United Kingdom

Site Status

Countries

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Denmark France Germany Netherlands Sweden United Kingdom

Other Identifiers

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TC-060112

Identifier Type: -

Identifier Source: org_study_id

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