Mitral Valve InsufficiencyReshape-HF2NCT02444338
A Clinical Evaluation of the Safety and Effectiveness of the MitraClip System in the Treatment of Clinically Significant Functional Mitral Regurgitation
A study testing MitraClip in people with Mitral Valve Insufficiency, run by University Medical Center Goettingen at 35 sites in 9 countries.
Trial summary
To study the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with New York Heart Association (NYHA) Functional Class II to Class 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
- What is being tested?
- MitraClip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 505 participants
- Where
- 35 sitesin 9 countries
- Study dates
- Mar 2015to 19 Apr 2024
- Phase
- Interventional
- 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
Who may be able to join
- Clinically significant functional mitral regurgitation (moderate-to-severe or severe MR) as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory Note: The TTE must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
- Assessed by the investigator to be on optimal standard of care therapy for heart failure, according to current ESC/HFA guidelines with no dose changes of heart failure drugs (with the exception of diuretics) during the last 2 weeks immediately prior to randomization.
- Symptomatic with documented New York Heart Association Class II, III or IV heart failure, despite optimal standard of care therapy, within 30 days preceding randomization
- Minimum of one documented hospitalization (acute care admission or emergency room visit) for heart failure within 12 months preceding randomization OR values of 300 pg/mL for BNP or 1000 pg/mL for NT-proBNP after optimal medical and/or device management within 90 days preceding randomization Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
- Ambulatory patient with symptomatic congestive heart failure (CHF) in NYHA functional class II to IV (despite optimal standard of care therapy as assessed within 30 days preceding randomization) and with LVEF 20% to 50%. Note: LVEF needs to be determined by one of the following methods: transthoracic echocardiography (TTE), contrast ventriculography, gated blood pool scan, cardiac magnetic resonance) within 90 days prior to randomization
- Patient is ambulatory and able to perform a 6MWT with the only limiting factor(s) being due to cardiovascular fitness
Who cannot join
- Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative MR) as determined by transesophageal echocardiography (TEE).
- Status 1 heart transplant or prior orthotropic heart transplantation.
- Introduction of a new heart failure drug class within the last 2 weeks prior to randomization.
- Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization. Note:Acute coronary syndrome (ACS) is defined as an ACS that requires an intervention. Increased troponin without acute symptoms and chest pain is not defined as ACS.
- Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery, or atrial fibrillation ablation within 90 days prior to randomization.
- Therapy with or without cardioverter-defibrillator (CRT or CRT-D), or Implantable Cardioverter Defibrillator (ICD)) within 90 day prior to randomization, or revision of any implanted rhythm management device within 90 days prior to randomization.
Show all 11Show fewer
- Need for any cardiovascular surgery.
- Mitral valve surgery is considered the preferred therapeutic option for the subject
- Renal replacement therapy
- 6-Minute Walk Test (6MWT) distance > 475 meters
- Mitral Valve Area (MVA) by planimetry < 4.0 cm2; if MVA by planimetry is not measurable, pressure half-time measurement is acceptable; MVA must be confirmed by the Echocardiography Core Laboratory
Trial locations and contacts
35 sites in 9 countries.
35 sites in 9 countries
Germany10 sites
Charité
Berlin, 12200
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Universitätsklinikum Essen
Essen, 45122
Johanniter Krankenhaus
Genthin, 39576
University Medical Center Goettingen
Göttingen, 37075
Universitätsklinikum Halle
Halle, 06097
University Hospital Heidelberg
Heidelberg, 69120
Universitätsklinikum Jena
Jena, 07747
University Hospital Mainz
Mainz, 55131
Universitätsklinik Würzburg
Würzburg, 97080
United Kingdom6 sites
Royal Infirmary of Edinburgh
Edinburgh
Golden Jubilee National Hospital
Glasgow
Castle Hill Hospital
Hull
The Royal Brompton and Harefield Hospitals
London
Wythenshawe Hospital of South Manchester - Manchester University NHS Foundation Trust (MFT)
Manchester
Royal Stoke Hospital - University Hospital of North Midlands
Stoke-on-Trent
Poland5 sites
Cardiology Department at Samodzielny Publiczny Szpital Kliniczny nr 7
Katowice, 40-635
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, 31-202
Poznan Medical University
Poznan, 61-848
Medical University Department of Heart Diseases
Wroclaw, 50981
Śląskie Centrum Chorób Serca
Zabrze, 41-800
Spain4 sites
Hospital Germans Trias i Pujol
Badalona
HUL Leon
León
Hospital Universitario Central de Asturias
Oviedo
Instituto de Ciencias del Corazón (ICICOR)
Valladolid
Greece3 sites
HYGEIA Hospital Athens
Athens
Interbalkan Medical Center
Thessaloniki, 57001
St. Luke's Hospital Thessaloniki
Thessaloniki
Portugal3 sites
Lisbon St. Marta Hospital
Lisbon, 1169-1024
Lisbon St. Maria Hospital
Lisbon
Centro Hospitalar Vila Nova de Gaia / Espinho
Vila Nova de Gaia
About this study
Official title: Randomised Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients With Clinically Significant Functional Mitral Regurgitation
To study the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with New York Heart Association (NYHA) Functional Class II to Class IV chronic heart failure.
Read the detailed description
The trial is designed to provide additional evidence regarding appropriate recommendations for use of the MitraClip System for patients with chronic heart failure and clinically significant functional mitral regurgitation. Additionally, the trial will collect evidence regarding health economics of the MitraClip System for use in this patient population.
- Conditions
- Mitral Valve Insufficiency
- Being tested
- MitraClip, standard of care
- 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.
MitraClipDevice
Implantation of the MitraClip System for patients with chronic heart failure.
standard of careOther
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | optimal standard of care therapy Receives: Other: standard of care |
| Device Group | Experimental | MitraClip device plus optimal standard of care therapy Receives: Device: MitraClip; Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death within 24 months
Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death within 24 months
Measured: 24 months
Rate of total (first and recurrent) HF hospitalizations within 24 months
Rate of total (first and recurrent) HF hospitalizations within 24 months
Measured: 24 months
Change in quality of life (i.e. overall KCCQ score) from baseline to 12 months
Change in quality of life (i.e. overall KCCQ score) from baseline to 12 months
Measured: 12 months
Secondary outcomes (5)
Percentage of patients with mitral regurgitation grade of 2+ or lower at 12 months as assessed by the Echocardiography Core Laboratory
Percentage of patients with mitral regurgitation grade of 2+ or lower at 12 months as assessed by the Echocardiography Core Laboratory
Measured: at 12 months
Change in 6 Minute Walking Test distance from baseline to 12 months
Change in 6 Minute Walking Test distance from baseline to 12 months
Measured: from baseline to 12 months
All-cause mortality during all available follow-up
All-cause mortality during all available follow-up
Measured: during all available follow-up
Rate of total (first and recurrent) hospitalizations for any cause within 24 months
Rate of total (first and recurrent) hospitalizations for any cause within 24 months
Measured: 24 months
Percentage of patients in NYHA function class I/II at 12 months
Percentage of patients in NYHA function class I/II at 12 months
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 posted14 May 2015 (estimated)
- Study startMar 2015
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karsten Gavenis, University Medical Center Goettingen
- Investigators
- Wolfgang Schillinger, Prof., Principal investigator, University Medical Center Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444338
- Sponsor's protocol ID
- Version No. 6.0
- Acronym
- Reshape-HF2
- Status last verified
- Sep 2024
- First submitted
- 12 May 2015
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anker SD, Friede T, von Bardeleben RS, Butler J, Khan MS, Diek M, Heinrich J, Geyer M, Placzek M, Ferrari R, Abraham WT, Alfieri O, Auricchio A, Bayes-Genis A, Cleland JGF, Filippatos G, Gustafsson F, Haverkamp W, Kelm M, Kuck KH, Landmesser U, Maggioni AP, Metra M, Ninios V, Petrie MC, Rassaf T, Ruschitzka F, Schafer U, Schulze PC, Spargias K, Vahanian A, Zamorano JL, Zeiher A, Karakas M, Koehler F, Lainscak M, Oner A, Mezilis N, Theofilogiannakos EK, Ninios I, Chrissoheris M, Kourkoveli P, Papadopoulos K, Smolka G, Wojakowski W, Reczuch K, Pinto FJ, Wiewiorka L, Kalarus Z, Adamo M, Santiago-Vacas E, Ruf TF, Gross M, Tongers J, Hasenfuss G, Schillinger W, Ponikowski P; RESHAPE-HF2 Investigators. Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation. N Engl J Med. 2024 Nov 14;391(19):1799-1809. doi: 10.1056/NEJMoa2314328. Epub 2024 Aug 31.
PubMed 39216092Anker SD, Friede T, von Bardeleben RS, Butler J, Fatima K, Diek M, Heinrich J, Hasenfuss G, Schillinger W, Ponikowski P. Randomized investigation of the MitraClip device in heart failure: Design and rationale of the RESHAPE-HF2 trial design. Eur J Heart Fail. 2024 Apr;26(4):984-993. doi: 10.1002/ejhf.3247. Epub 2024 Apr 23.
PubMed 38654139McMurray JJV, Metra M. Transcatheter Repair of Secondary Mitral Regurgitation. N Engl J Med. 2023 Jun 1;388(22):2097-2098. doi: 10.1056/NEJMe2302924. No abstract available.
PubMed 37256981
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients With Clinically Significant Functional Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT02444338
- Acronym / sponsor ID
- Reshape-HF2 / Version No. 6.0
- Conditions
- Mitral Valve Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- 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 study the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with New York Heart Association (NYHA) Functional Class II to Class IV chronic heart failure.
Detailed description
The trial is designed to provide additional evidence regarding appropriate recommendations for use of the MitraClip System for patients with chronic heart failure and clinically significant functional mitral regurgitation. Additionally, the trial will collect evidence regarding health economics of the MitraClip System for use in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: standard of careoptimal standard of care therapy |
| Device Group | Experimental | Device: MitraClip, Other: standard of careMitraClip device 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
Key inclusion criteria (6 listed)
- Clinically significant functional mitral regurgitation (moderate-to-severe or severe MR) as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory Note: The TTE must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
- Assessed by the investigator to be on optimal standard of care therapy for heart failure, according to current ESC/HFA guidelines with no dose changes of heart failure drugs (with the exception of diuretics) during the last 2 weeks immediately prior to randomization.
- Symptomatic with documented New York Heart Association Class II, III or IV heart failure, despite optimal standard of care therapy, within 30 days preceding randomization
- Minimum of one documented hospitalization (acute care admission or emergency room visit) for heart failure within 12 months preceding randomization OR values of 300 pg/mL for BNP or 1000 pg/mL for NT-proBNP after optimal medical and/or device management within 90 days preceding randomization Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
- Ambulatory patient with symptomatic congestive heart failure (CHF) in NYHA functional class II to IV (despite optimal standard of care therapy as assessed within 30 days preceding randomization) and with LVEF 20% to 50%. Note: LVEF needs to be determined by one of the following methods: transthoracic echocardiography (TTE), contrast ventriculography, gated blood pool scan, cardiac magnetic resonance) within 90 days prior to randomization
Key exclusion criteria (11 listed)
- Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative MR) as determined by transesophageal echocardiography (TEE).
- Status 1 heart transplant or prior orthotropic heart transplantation.
- Introduction of a new heart failure drug class within the last 2 weeks prior to randomization.
- Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization. Note:Acute coronary syndrome (ACS) is defined as an ACS that requires an intervention. Increased troponin without acute symptoms and chest pain is not defined as ACS.
- Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery, or atrial fibrillation ablation within 90 days prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitraClipImplantation of the MitraClip System for patients with chronic heart failure. | Device | Device Group |
| standard of care | Other | Control Group, Device Group |
Primary outcome
Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death within 24 months
Time frame: 24 months
Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death within 24 months
Rate of total (first and recurrent) HF hospitalizations within 24 months
Time frame: 24 months
Rate of total (first and recurrent) HF hospitalizations within 24 months
Change in quality of life (i.e. overall KCCQ score) from baseline to 12 months
Time frame: 12 months
Change in quality of life (i.e. overall KCCQ score) from baseline to 12 months
5 secondary outcomes
Percentage of patients with mitral regurgitation grade of 2+ or lower at 12 months as assessed by the Echocardiography Core Laboratory
Time frame: at 12 months
Change in 6 Minute Walking Test distance from baseline to 12 months
Time frame: from baseline to 12 months
All-cause mortality during all available follow-up
Time frame: during all available follow-up
Rate of total (first and recurrent) hospitalizations for any cause within 24 months
Time frame: 24 months
Percentage of patients in NYHA function class I/II at 12 months
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 19 Sep 2024.
- Results publication: PubMed 39216092Anker SD, Friede T, von Bardeleben RS, Butler J, Khan MS, Diek M, Heinrich J, Geyer M, Placzek M, Ferrari R, Abraham WT, Alfieri O, Auricchio A, Bayes-Genis A, Cleland JGF, Filippatos G, Gustafsson F, Haverkamp W, Kelm M, Kuck KH, Landmesser U, Maggioni AP, Metra M, Ninios V, Petrie MC, Rassaf T, Ruschitzka F, Schafer U, Schulze PC, Spargias K, Vahanian A, Zamorano JL, Zeiher A, Karakas M, Koehler F, Lainscak M, Oner A, Mezilis N, Theofilogiannakos EK, Ninios I, Chrissoheris M, Kourkoveli P, Papadopoulos K, Smolka G, Wojakowski W, Reczuch K, Pinto FJ, Wiewiorka L, Kalarus Z, Adamo M, Santiago-Vacas E, Ruf TF, Gross M, Tongers J, Hasenfuss G, Schillinger W, Ponikowski P; RESHAPE-HF2 Investigators. Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation. N Engl J Med. 2024 Nov 14;391(19):1799-1809. doi: 10.1056/NEJMoa2314328. Epub 2024 Aug 31.
- Results publication: PubMed 38654139Anker SD, Friede T, von Bardeleben RS, Butler J, Fatima K, Diek M, Heinrich J, Hasenfuss G, Schillinger W, Ponikowski P. Randomized investigation of the MitraClip device in heart failure: Design and rationale of the RESHAPE-HF2 trial design. Eur J Heart Fail. 2024 Apr;26(4):984-993. doi: 10.1002/ejhf.3247. Epub 2024 Apr 23.
- Derived from this study: PubMed 37256981McMurray JJV, Metra M. Transcatheter Repair of Secondary Mitral Regurgitation. N Engl J Med. 2023 Jun 1;388(22):2097-2098. doi: 10.1056/NEJMe2302924. No abstract available.
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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.
Wolfgang Schillinger, Prof. principal investigator
University Medical Center Göttingen
35 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MitraClip in people with Mitral Valve Insufficiency, run by University Medical Center Goettingen at 35 sites in 9 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 11 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Germany, United Kingdom, Poland, Spain, Greece and 4 more countries. 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?
Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death within 24 months (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02444338, which also lists 3 linked publications.
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 19 Sep 2024.