NCT01626404

Completed

Screening for Advanced Heart Failure Treatment (SEE-HF)

Abbott Medical Devices Source

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Other study identifiers

Sponsor study identifier

TC-060112

Study Type

observational

Actual enrollment (reported)

99

Locations

6 countries

Sites

7

Timeline

Study Start

October 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2016

Actual (reported)

Study Completion

February 2016

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 99 participants
Study completion date: February 2016
Actual (reported)
Listed locations: 6 countries · 7 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 20, 2012
Actual (reported)
First Posted
June 22, 2012
Actual (reported)
Study Start
October 2012
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
February 2016
Actual (reported)
Study Completion
February 2016
Actual (reported)

Last Updated: June 24, 2022
Status Verified: June 2022
Last Update Submitted: June 23, 2022

Conditions

Advanced Heart Failure CRT and/or ICD

Keywords

Thoratec Corporation

Outcome Measures

Primary Outcomes (1)

Proportion of patients
Proportion of heart failure patients followed in outpatient clinic that are NYHA III-IV with LVEF \</= 40% and a CRT and/or ICD who have an indication without contraindication for heart transplantationi and/or DT LVAD.
12 months

Secondary Outcomes (4)

Reasons for non-referral
12 months
Patient's reasons
12 months
Actual and predicted 12 month survival
12 months
Simple clinical parameters for referral
12 months

Study Arms (1)

Patients enrolled

All patients enrolled in the study

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Outpatients with CRT and/or ICD, EF \</= 40% and in NYHA III-IV

You may qualify if:

CRT and or ICD device in place.

Sponsors & Collaborators

Thoratec Europe Ltd
Industrycollaborator
Abbott Medical Devices
Industrylead

Study Sites (7)

Rigshospitalet

Copenhagen, Denmark

CHU of Nantes

Nantes, France

Hannover Medical Center

Hanover, Germany

University Clinical Center Tuebingen

Tübingen, Germany

Erasmus Medical Center

Rotterdam, Netherlands

Karolinska University Hospital

Stockholm, Sweden

University Hospital of South Manchester NHS Trust

Manchester, United Kingdom

Study Officials

Pooja Chatterjee
Thoratec Europe Limited
STUDY DIRECTOR

Enrollment

99 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 20, 2012

First Posted

June 22, 2012

Study Start

October 2012

Date type not reported

This date has not been verified as actual or estimated.

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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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

February 2016

Actual (reported)

Study Completion

February 2016

Actual (reported)

Last Updated

June 24, 2022

Record last verified: 2022-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01626404
Data provider: ClinicalTrials.gov
Source updated: 2022-06-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:06 UTC

Locations

DE(2)DK(1)FR(1)GB(1)NL(1)SE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Patients enrolled

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations