Mitral Valve InsufficiencyNCT02444286
The RESHAPE-HF1-FU Study
An observational study of Mitral Valve Insufficiency, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 2 sites in Germany.
Trial summary
To evaluate the safety and efficiency of the MitraClip system in the treatment of patients with clinically significant mitral regurgitation with New York Heart Association (NYHA) Functional Class II to IV chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency
- How many people
- 0 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2017to Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The RESHAPE- HF1-FU Study is an observational, multi-center clinical evaluation (follow-up) of the MitraClip device plus optimal standard of care therapy (subjects with Device) compared to optimal standard of care therapy alone (other subjects), of former participants in the RESHAPE-HF Trial (Abbott Vascular).
Who may be able to join
- Former participant in the RESHAPE-HF Trial (Abbott Vascular)
- Subject agrees to return for all required follow-up visits
- The subject has been informed of the nature of the study and agrees to the study's provisions and has provided written informed consent as approved by the respective clinical site's Ethics Committee
Who cannot join
- Withdrawal of Informed Consent
- Subject belongs to a vulnerable population
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Medical Center Goettingen
Göttingen, 37075
University Hospital Mainz
Mainz, 55131
About this study
Official title: Observational Study of Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation - Follow Up of the Former Participants in the RESHAPE-HF Trial (Abbott Vascular).
To evaluate the safety and efficiency of the MitraClip system in the treatment of patients with clinically significant mitral regurgitation with New York Heart Association (NYHA) Functional Class II to IV chronic heart failure.
Read the detailed description
The purpose of the RESHAPE-HF1-FU Study is to follow up the safety and effectiveness of the MitraClip System in the treatment of clinically significant Functional Mitral Regurgitation (FMR) in patients with New York Heart Association (NYHA) Functional Class III or IV chronic heart failure, former participants in the RESHAPE-HF Trial (Abbott Vascular).
- Conditions
- Mitral Valve Insufficiency
- Medical subject headings
- Mitral Valve Insufficiency
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 |
|---|---|---|
| standard care group | optimal standard of care therapy | |
| device group | Follow-up of MitraClip device implantation plus optimal standard of care therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular (CV) death
Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death
Measured: 24 months
Secondary outcomes (6)
Mitral Regurgitation (MR) severity reduction
Mitral Regurgitation (MR) severity reduction to mild or mild-to-moderate at 12 and 24 months
Measured: at 12 and 24 months
6 Minute Walk Test (6MWT)
Change in 6 Minute Walk Test (6MWT) distance at 6, 12 and 24 months over baseline
Measured: at 6, 12 and 24 months
CV hospitalizations and CV death
Rate of recurrent CV hospitalizations and CV death
Measured: 24 months
Quality of Life (QoL)
Change in Quality of Life (QoL) overall score, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months over baseline
Measured: 12 months
New York Heart Association (NYHA) Functional Class
Change in New York Heart Association (NYHA) Functional Class over baseline and proportions of patients in NYHA Functional Class I/II at 6, 12 and 24 months
Measured: 6, 12 and 24 months
Patient-reported Global Assessment (PGA)
Change in Patient-reported Global Assessment (PGA) of well-being at 6, 12 and 24 months
Measured: 6, 12 and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startJan 2017 (estimated)
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: study did never start, may be deleted from clinicaltrials.gov if possible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Goettingen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444286
- Sponsor's protocol ID
- Version No. 1.0
- Status last verified
- Jan 2019
- First submitted
- 12 May 2015
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation - Follow Up of the Former Participants in the RESHAPE-HF Trial (Abbott Vascular).
- ClinicalTrials.gov ID
- NCT02444286
- Acronym / sponsor ID
- Version No. 1.0
- Conditions
- Mitral Valve Insufficiency
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study did never start, may be deleted from clinicaltrials.gov if possible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbHUniversity, hospital or other
- Collaborators
- University Medical Center Goettingen
- Study start
- Jan 2017 (estimated)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 14 May 2015 (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.
To evaluate the safety and efficiency of the MitraClip system in the treatment of patients with clinically significant mitral regurgitation with New York Heart Association (NYHA) Functional Class II to IV chronic heart failure.
Detailed description
The purpose of the RESHAPE-HF1-FU Study is to follow up the safety and effectiveness of the MitraClip System in the treatment of clinically significant Functional Mitral Regurgitation (FMR) in patients with New York Heart Association (NYHA) Functional Class III or IV chronic heart failure, former participants in the RESHAPE-HF Trial (Abbott Vascular).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care group | – | –optimal standard of care therapy |
| device group | – | –Follow-up of MitraClip device implantation plus optimal standard of care therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The RESHAPE- HF1-FU Study is an observational, multi-center clinical evaluation (follow-up) of the MitraClip device plus optimal standard of care therapy (subjects with Device) compared to optimal standard of care therapy alone (other subjects), of former participants in the RESHAPE-HF Trial (Abbott Vascular).
Key inclusion criteria (3 listed)
- Former participant in the RESHAPE-HF Trial (Abbott Vascular)
- Subject agrees to return for all required follow-up visits
- The subject has been informed of the nature of the study and agrees to the study's provisions and has provided written informed consent as approved by the respective clinical site's Ethics Committee
Key exclusion criteria (2 listed)
- Withdrawal of Informed Consent
- Subject belongs to a vulnerable population
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
cardiovascular (CV) death
Time frame: 24 months
Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death
6 secondary outcomes
Mitral Regurgitation (MR) severity reduction
Time frame: at 12 and 24 months
6 Minute Walk Test (6MWT)
Time frame: at 6, 12 and 24 months
CV hospitalizations and CV death
Time frame: 24 months
Quality of Life (QoL)
Time frame: 12 months
New York Heart Association (NYHA) Functional Class
Time frame: 6, 12 and 24 months
Patient-reported Global Assessment (PGA)
Time frame: 6, 12 and 24 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Insufficiency, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 2 sites in Germany.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 was withdrawn before enrolling participants, so there are no results.
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?
cardiovascular (CV) death (time frame: 24 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 5 Jan 2024.