Advanced Heart FailureSEE-HFNCT01626404
Screening for Advanced Heart Failure Treatment (SEE-HF)
An observational study of Advanced Heart Failure and CRT and/or ICD, run by Abbott Medical Devices at 7 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Heart Failure, CRT and/or ICD
- How many people
- 99 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Oct 2012to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients with CRT and/or ICD, EF </= 40% and in NYHA III-IV
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Known diagnosis of dementia
- Patient is currently on dialysis
- Oxygen dependent lung disease
- Previously or currently treated with LVAD or heart transplantation
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Germany2 sites
Hannover Medical Center
Hanover
University Clinical Center Tuebingen
Tübingen
United Kingdom1 site
University Hospital of South Manchester NHS Trust
Manchester
About this study
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.
- Conditions
- Advanced Heart Failure, CRT and/or ICD
- Keywords
- Thoratec Corporation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients enrolled | All patients enrolled in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
Reasons for non-referral
Assess physician's reasons for non-referral of patients for LVAD/transplant evaluation.
Measured: 12 months
Patient's reasons
Assess patients reasons for declining LVAD/transplant as a treatment option.
Measured: 12 months
Actual and predicted 12 month survival
Assess the actual and predicted 12 month survival (predicted by VO2, the Heart Failure Survival Score (HFSS) and the Seattle Heart Failure Model (SHFM)).
Measured: 12 months
Simple clinical parameters for referral
Identify simple clinical parameters that can be used by physicians to refer patients for LVAD/transplant evaluation at an optimal time.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thoratec Europe Ltd
- Responsible party
- Sponsor
- Investigators
- Pooja Chatterjee, Study director, Thoratec Europe Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626404
- Sponsor's protocol ID
- TC-060112
- Acronym
- SEE-HF
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2012
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Advanced Heart Failure Treatment (SEE-HF)
- ClinicalTrials.gov ID
- NCT01626404
- Acronym / sponsor ID
- SEE-HF / TC-060112
- Conditions
- Advanced Heart Failure, CRT and/or ICD
- Keywords
- Thoratec Corporation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Thoratec Europe Ltd
- Study start
- Oct 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 22 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients enrolled | – | –All patients enrolled in the study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with CRT and/or ICD, EF </= 40% and in NYHA III-IV
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients
Time frame: 12 months
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.
4 secondary outcomes
Reasons for non-referral
Time frame: 12 months
Patient's reasons
Time frame: 12 months
Actual and predicted 12 month survival
Time frame: 12 months
Simple clinical parameters for referral
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pooja Chatterjee study director
Thoratec Europe Limited
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Heart Failure and CRT and/or ICD, run by Abbott Medical Devices at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Denmark, France, Netherlands, Sweden and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.