Severe Tricuspid RegurgitationPhase 2/3NCT02387697
Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL)
A Phase 2/3 study testing Edwards Sapien XT Valve in people with Severe Tricuspid Regurgitation, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to assess the efficacy and safety of implanting an Edwards Sapien XT Valve into the vena cava inferior (VCI; between right atrium and the hepatic vein) on clinical variables, exercise tolerance and well being in patients with severe tricuspid regurgitation and signs of right heart failure. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Severe Tricuspid Regurgitation
- What is being tested?
- Edwards Sapien XT Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to May 2018
- Phase
- Phase 2/3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe symptomatic tricuspid regurgitation with a significant regurgitation jet into the caval and hepatic veins
- Optimal medical treatment
- High surgical risk with STS Score ≥ 10 or logistic EuroSCORE I ≥ 15 or any contraindication for conventional valve replacement/repair
- NYHA class of at least II
- Written informed consent
Who cannot join
- VCI diameter > 32 mm
- Severe left ventricular dysfunction with LVEF < 30%
- Severe mitral insufficiency
- Estimated life expectancy < 12months (360 days) due to carcinoma, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease
- Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
- Evidence of stroke / TIA during the last 180 days
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- Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cells/mL), or any known blood clotting disorder
- Evidence of an intracardiac mass, thrombus or vegetation
- Active upper GI bleeding within 1 month (30 days) prior to procedure
- Patients with an acute emergency
- Contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure
- Allergy against the use of implanted stent / prosthesis
- Patient undergoing regular dialysis or a serum creatinine above 3.0 mg/dl
- Patients unsuitable for implantation because of thrombosis of the lower venous system or vena cava filter
- Active bacterial endocarditis within 6 months (180 days) of procedure.
- Women of childbearing potential without highly effective contraception (PEARL-Index < 1%)
- Inability to comply with all of the study procedures and follow-up visits
- Subjects who are legally detained in an official institute (according to § 20 MPG)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charite Universitaetsmedizin, Medizinische Klinik für Kardiologie und Angiologie
Berlin, 10117
About this study
Official title: Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve
The purpose of this study is to assess the efficacy and safety of implanting an Edwards Sapien XT Valve into the vena cava inferior (VCI; between right atrium and the hepatic vein) on clinical variables, exercise tolerance and well being in patients with severe tricuspid regurgitation and signs of right heart failure.
- Conditions
- Severe Tricuspid Regurgitation
- Being tested
- Edwards Sapien XT Valve
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards Sapien XT ValveDevice
The device will be implanted in the present study to prevent abdominal venous congestion and to improve the function of the tricuspid valve which is located in the low pressure system in the right heart.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Transfemoral implantation of an Edwards Sapien XT Valve into the vena cava inferior (VCI). For better stability and for downsizing of the VCI diameter the valve will be implanted after preparation of a landing zone. This includes implantation of one or two self expandable stents into the VCI prior to the final deployment of the valve. Receives: Device: Edwards Sapien XT Valve |
| Group B | No intervention | Control group (no surgery) with optimal medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum relative VO2 uptake
we consider the difference of means in maximum relative VO2 uptake at 3 months compared to control group.
Measured: at 3 month
Secondary outcomes (13)
NYHA class
Measured: day 30 and month 3
ejection fraction (EF)
Measured: day 30 and month 3
right ventricular (RV) diameter
Measured: day 30 and month 3
right atrial (RA) diameter
Measured: day 30 and month 3
hepatic vein diameter
Measured: day 30 and month 3
N-terminal pro Brain Natriuretic Peptide (NT-proBNP)
Measured: day 30 and month 3
tricuspid regurgitation jet velocity time integral (as assessed by Doppler echocardiography)
Measured: day 30 and month 3
aerobic threshold (assessed by spiroergometry)
Measured: day 30 and month 3
ventilation efficiency (as assessed by the VE / VCO2 slope in spiroergometry)
Measured: day 30 and month 3
Unscheduled rehospitalization
Measured: day 30 and month 3
Dyspnoea VAS
Measured: day 30 and month 3
Minnesota Living with Heart Failure Questionnaire
Measured: day 30 and month 3
6-minutes walk test
Measured: day 30 and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2018
- Study completionMay 2018
Why it stopped: Safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, Prof. Dr. med. Karl Stangl, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387697
- Sponsor's protocol ID
- TRICAVAL
- Status last verified
- Sep 2018
- First submitted
- 27 Feb 2015
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mattig I, Hewing B, Knebel F, Meisel C, Ludwig A, Konietschke F, Stangl V, Stangl K, Laule M, Dreger H. Effect of inferior caval valve implantation on circulating immune cells and inflammatory mediators in severe tricuspid regurgitation. BMC Cardiovasc Disord. 2024 Jul 18;24(1):373. doi: 10.1186/s12872-024-04044-1.
PubMed 39026154
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve
- ClinicalTrials.gov ID
- NCT02387697
- Acronym / sponsor ID
- TRICAVAL
- Conditions
- Severe Tricuspid Regurgitation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety concerns
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- Jan 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 13 Mar 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.
The purpose of this study is to assess the efficacy and safety of implanting an Edwards Sapien XT Valve into the vena cava inferior (VCI; between right atrium and the hepatic vein) on clinical variables, exercise tolerance and well being in patients with severe tricuspid regurgitation and signs of right heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Edwards Sapien XT ValveTransfemoral implantation of an Edwards Sapien XT Valve into the vena cava inferior (VCI). For better stability and for downsizing of the VCI diameter the valve will be implanted after preparation of a landing zone. This includes implantation of one or two self expandable stents into the VCI prior to the final deployment of the valve. |
| Group B | No intervention | –Control group (no surgery) with optimal medical treatment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Severe symptomatic tricuspid regurgitation with a significant regurgitation jet into the caval and hepatic veins
- Optimal medical treatment
- High surgical risk with STS Score ≥ 10 or logistic EuroSCORE I ≥ 15 or any contraindication for conventional valve replacement/repair
- NYHA class of at least II
- Written informed consent
Key exclusion criteria (18 listed)
- VCI diameter > 32 mm
- Severe left ventricular dysfunction with LVEF < 30%
- Severe mitral insufficiency
- Estimated life expectancy < 12months (360 days) due to carcinoma, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease
- Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
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 |
|---|---|---|
| Edwards Sapien XT ValveThe device will be implanted in the present study to prevent abdominal venous congestion and to improve the function of the tricuspid valve which is located in the low pressure system in the right heart. | Device | Group A |
Primary outcome
Maximum relative VO2 uptake
Time frame: at 3 month
we consider the difference of means in maximum relative VO2 uptake at 3 months compared to control group.
13 secondary outcomes
NYHA class
Time frame: day 30 and month 3
ejection fraction (EF)
Time frame: day 30 and month 3
right ventricular (RV) diameter
Time frame: day 30 and month 3
right atrial (RA) diameter
Time frame: day 30 and month 3
hepatic vein diameter
Time frame: day 30 and month 3
N-terminal pro Brain Natriuretic Peptide (NT-proBNP)
Time frame: day 30 and month 3
tricuspid regurgitation jet velocity time integral (as assessed by Doppler echocardiography)
Time frame: day 30 and month 3
aerobic threshold (assessed by spiroergometry)
Time frame: day 30 and month 3
ventilation efficiency (as assessed by the VE / VCO2 slope in spiroergometry)
Time frame: day 30 and month 3
Unscheduled rehospitalization
Time frame: day 30 and month 3
Dyspnoea VAS
Time frame: day 30 and month 3
Minnesota Living with Heart Failure Questionnaire
Time frame: day 30 and month 3
6-minutes walk test
Time frame: day 30 and month 3
Results and safety
The study was stopped early (reason given: Safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Derived from this study: PubMed 39026154Mattig I, Hewing B, Knebel F, Meisel C, Ludwig A, Konietschke F, Stangl V, Stangl K, Laule M, Dreger H. Effect of inferior caval valve implantation on circulating immune cells and inflammatory mediators in severe tricuspid regurgitation. BMC Cardiovasc Disord. 2024 Jul 18;24(1):373. doi: 10.1186/s12872-024-04044-1.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Edwards Sapien XT Valve in people with Severe Tricuspid Regurgitation, run by Charite University, Berlin, Germany at 1 site 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 5 inclusion and 18 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: stopped early, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Safety concerns). Results are not available in the source record.
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?
Maximum relative VO2 uptake (time frame: at 3 month). 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 NCT02387697, which also lists 1 linked publication.
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 18 Sep 2018.