Tricuspid Valve InsufficiencyTRI-REPAIRNCT02981953
TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System
A study testing Cardioband Tricuspid in people with Tricuspid Valve Insufficiency and Tricuspid Regurgitation, run by Edwards Lifesciences at 8 sites in 3 countries.
Trial summary
The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement. TR can worsen or appear late after successful mitral valve surgery which portends a poor prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Valve Insufficiency, Tricuspid Regurgitation, Tricuspid Valve Regurgitation
- What is being tested?
- Cardioband Tricuspid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Oct 2016to 12 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Chronic functional tricuspid regurgitation (FTR) with annular diameter ≥ 40 mm with valve Systolic pulmonary pressure (sPAP) ≤ 60mmHg
- ≥18 years old
- New York Heart Association (NYHA) Class II-IVa
- Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen
- LVEF ≥ 30%
- Patient is willing and able to comply with all specified study evaluations
- The Local Site Heart Team concur that surgery will not be offered as a treatment option
- Transfemoral access of the Cardioband is determined to be feasible
Who cannot join
- Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation ≥ moderate
- Severe uncontrolled hypertension (Systolic BP ≥ 180 mmHg and/or Diastolic BP ≥ 110 mm Hg)
- Previous tricuspid valve repair or replacement
- Trans-tricuspid pacemaker or defibrillator leads suggesting impingement of the of the tricuspid valve leaflets, as evaluated by echocardiography
- Active endocarditis
- MI or known unstable angina within the 30 days prior to the index procedure
Show all 27Show fewer
- Any percutaneous coronary intervention (PCI) or transcatheter valvular intervention within 30 days prior to the index
- Hemodynamic instability or on IV inotropes
- Cerebrovascular Accident (CVA) within the past 6 months
- Subject is on chronic dialysis
- Anemia (Hb < 9 g/dL) not corrected by transfusion
- Bleeding disorders or hypercoaguable state
- Active peptic ulcer or active gastrointestinal (GI) bleeding
- Contraindication to anticoagulants
- Known allergy to stainless steel, nickel, and/or polyester
- Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
- In the judgment of the Investigator, co-morbid condition(s) that could limit the subject's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
- Life expectancy of less than 12 months
- Impaired judgment and/or is undergoing emergency treatment
- Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
- intra-cardiac masses, thrombi or vegetations
- Patients with cardiac cachexia
- Subjects in whom transesophageal echocardiography is contraindicated
- . Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
- Untreated clinically significant CAD requiring revascularization
- Echocardiographic evidence of severe right ventricular dysfunction
- Any coronary or endovascular surgery, within 3 months prior to procedure
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany6 sites
Bonn University - Universitätsklinikum Bonn
Bonn
Universitätsklinikum Köln
Cologne
Asklepios Klinik, St. Georg
Hamburg, 5 20099
Universitätsklinik Hamburg Eppendorf, Herzzentrum
Hamburg
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz
LMU Klinikum der Universität München, Medizinische Klinik I
Munich
About this study
The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement. TR can worsen or appear late after successful mitral valve surgery which portends a poor prognosis. However, standard surgical approaches requiring cardiopulmonary bypass and especially second surgery have an excessive risks. Thus many patients are denied surgery because of unfavorable risk-benefit balance. Therefore there is a need for novel devices enabling interventional cardiologists and cardiothoracic surgeons to perform tricuspid annuloplasty by transcatheter methods. Cardioband replicates established surgical techniques (e.g., annuloplasty) using transfemoral approach, without sutures and with adjusted on the beating heart. Similar to the approved indication for mitral annuloplasty. The Cardioband System is expected to allow for treatment of patients that would otherwise not undergo Tricuspid valve repair due to the invasiveness of current techniques.
Read the detailed description
The Cardioband Transcatheter System (Cardioband) is a marketed system that was approved for treatment of secondary (functional) mitral regurgitation (FMR) (CE granted on September 2015). The Cardioband is an annuloplasty band that is similar to a surgical annuloplasty, however deployed on the beating heart through a transvenous approach. The CE mark study with 30 subjects has been completed and documented significant reduction of severity of MR and improvement in quality of life by Minnesota living with heart failure questionnaire (MLHFQ), New York Heart Association (NYHA) and 6- minute walk test (6MWT), in subjects with moderate to severe MR. The aim of the current study is to evaluate the Cardioband annuloplasty system for repair the Tricuspid Regurgitation.
- Conditions
- Tricuspid Valve Insufficiency, Tricuspid Regurgitation, Tricuspid Valve Regurgitation, Cardiovascular Diseases, Heart Valve Diseases, Heart Diseases
- Being tested
- Cardioband Tricuspid
- Keywords
- Valtech Cardio, Cardioband, Tricuspid
- Medical subject headings
- Tricuspid Valve Insufficiency, Cardiovascular Diseases, Heart Valve Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardioband TricuspidDevice
The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
| Study group | Role | What they receive |
|---|---|---|
| Cardioband Tricuspid procedure | Other | Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Receives: Device: Cardioband Tricuspid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE)
Overall rate of Major Serious Adverse Events (MSAEs)* and serious adverse device effects (SADE)
Measured: 30 days
Access, Deployment and Positioning of the Cardioband Device
Successful access, deployment and positioning of the Cardioband device
Measured: Intra-procedure
Secondary outcomes (26)
Technical Success
Successful access, deployment and positioning of the Cardioband device and septolateral reduction.
Measured: 1, 6, 12, and 24 months
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, and Severe. Data analysis per core lab.
Measured: 1, 6, 12, and 24 months over baseline
Tricuspid Regurgitation [Full Analysis Data Set]
All data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, Severe. Data analysis per core lab.
Measured: 1, 6, 12, and 24 months over baseline
Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]
Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab
Measured: 1, 6, 12, and 24 months over baseline
Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set]
All data available for Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Measured: 1, 6, 12, and 24 months over baseline
Regurgitant Volume [Paired Baseline and Follow-Up]
Regurgitant Volume (by Echocardiography) data available at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Measured: 1, 6, 12, and 24 months over baseline
Regurgitant Volume [Full Analysis Data Set]
All data for Regurgitant Volume (by Echocardiography) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Measured: 1, 6, 12, and 24 months over baseline
TAPSE [Paired Baseline and Follow-Up]
Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Measured: 1, 6, 12, and 24 months over baseline
TAPSE [Full Analysis Data Set]
All data for Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analyses based on core lab assessment.
Measured: 1, 6, 12, and 24 months over baseline
NYHA [Paired Baseline and Follow-Up]
NYHA classification data available at 1 month, 6 months, 12 months, 24 months over baseline.
Measure Description: NYHA Classification - The stages of heart failure:
- Class I - No symptoms and no limitation in ordinary physical activity
- Class II - Mild symptoms and slight limitation during ordinary activity.
- Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.
- Class IV - Severe limitations. Experiences symptoms even while at rest.
Measured: 1, 6, 12, and 24 months over baseline
NYHA [Full Analysis Data Set]
All data available for NYHA classification at 1 month, 6 months, 12 months, and 24 months over baseline.
Measure Description: NYHA Classification - The stages of heart failure:
- Class I - No symptoms and no limitation in ordinary physical activity
- Class II - Mild symptoms and slight limitation during ordinary activity.
- Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.
- Class IV - Severe limitations. Experiences symptoms even while at rest.
Measured: 1, 6, 12, and 24 months over baseline
6MWT [Paired Baseline and Follow-Up]
Distance in meters walked during 6 Minute Walk Test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.
Measured: 1, 6, 12, and 24 months over baseline
6MWT [Full Analysis Data Set]
Distance in meters walked during 6 minute walk test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.
Measured: 1, 6, 12, and 24 months over baseline
Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.
Measured: 1, 6, 12, and 24 months over baseline
Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set]
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.
Measured: 1, 6, 12, and 24 months over baseline
Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]
Left ventricle ejection fraction data available for 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis based on core lab assessment.
Measured: 1, 6, 12, and 24 months over baseline
Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set]
All available data for left ventricle ejection fraction at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per echo core lab.
Measured: 1, 6, 12, and 24 months over baseline
Left Ventricle End Diastolic Volume Index (LVEDVI) [Full Analysis Data Set]
Left ventricle end diastolic volume index data available for 1 month, 6 months, 12 months, and 24 months over baseline.
Measured: 1, 6, 12, and 24 months over baseline
Left Ventricle End Systolic Volume Index (LVESVI) [Full Analysis Data Set]
Left ventricle end systolic volume index data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Measured: 1, 6, 12, and 24 months over baseline
NT-pro BNP [Full Analysis Data Set]
N-terminal prohormone of brain natriuretic peptide data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Measured: 1, 6, 12, and 24 months over baseline
Diuretic Therapy
Diuretic Therapy data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Measured: 1, 6, 12, and 24 months over baseline
Bilirubin [Full Analysis Data Set]
Bilirubin data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Measured: 1, 6, 12, and 24 months over baseline
Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set]
All available data for Blood urea nitrogen (BUN) and Serum Creatinine at 1 month, 6 months, 12 months, and 24 months over baseline.
Measured: 1, 6, 12, and 24 months over baseline
Activity by Wearable Device
Activity by wearable device available data at 1 month, 6 months, 12 months, and 24 months over baseline.
Measured: 1, 6, 12, and 24 months over baseline
Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set]
All data available for Glutamic oxaloacetic transaminase (GOT) and Aspartate Transaminase (AST) at 1 month, 6 months, 12 months, and 24 months over baseline.
Measured: 1, 6, 12, and 24 months over baseline
Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set]
All data available for glutamic pyruvic transaminase (GPT) Alanine Transaminase (ALT) at 1 month, 6 months, 12 months, and 24 months.
Measured: 1, 6, 12, and 24 months over baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startOct 2016
- Primary completion1 Jan 2018
- Study completion12 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tricuspid Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georg Nickenig, MD, Principal investigator, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981953
- Sponsor's protocol ID
- TR1-1
- Acronym
- TRI-REPAIR
- Status last verified
- Jun 2021
- First submitted
- 20 Nov 2016
- Last updated
- 28 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nickenig G, Weber M, Schuler R, Hausleiter J, Nabauer M, von Bardeleben RS, Sotiriou E, Schafer U, Deuschl F, Alessandrini H, Kreidel F, Juliard JM, Brochet E, Latib A, Montorfano M, Agricola E, Baldus S, Friedrichs KP, Deo SH, Gilmore SY, Feldman T, Hahn RT, Maisano F. Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study. EuroIntervention. 2021 Feb 5;16(15):e1264-e1271. doi: 10.4244/EIJ-D-20-01107.
PubMed 33046437Nickenig G, Weber M, Schueler R, Hausleiter J, Nabauer M, von Bardeleben RS, Sotiriou E, Schafer U, Deuschl F, Kuck KH, Kreidel F, Juliard JM, Brochet E, Latib A, Agricola E, Baldus S, Friedrichs K, Vandrangi P, Verta P, Hahn RT, Maisano F. 6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation. J Am Coll Cardiol. 2019 Apr 23;73(15):1905-1915. doi: 10.1016/j.jacc.2019.01.062.
PubMed 30999993
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System
- ClinicalTrials.gov ID
- NCT02981953
- Acronym / sponsor ID
- TRI-REPAIR / TR1-1
- Conditions
- Tricuspid Valve Insufficiency, Tricuspid Regurgitation, Tricuspid Valve Regurgitation, Cardiovascular Diseases, Heart Valve Diseases, Heart Diseases
- Keywords
- Valtech Cardio, Cardioband, Tricuspid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Posted 28 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement. TR can worsen or appear late after successful mitral valve surgery which portends a poor prognosis. However, standard surgical approaches requiring cardiopulmonary bypass and especially second surgery have an excessive risks. Thus many patients are denied surgery because of unfavorable risk-benefit balance. Therefore there is a need for novel devices enabling interventional cardiologists and cardiothoracic surgeons to perform tricuspid annuloplasty by transcatheter methods. Cardioband replicates established surgical techniques (e.g., annuloplasty) using transfemoral approach, without sutures and with adjusted on the beating heart. Similar to the approved indication for mitral annuloplasty. The Cardioband System is expected to allow for treatment of patients that would otherwise not undergo Tricuspid valve repair due to the invasiveness of current techniques.
Detailed description
The Cardioband Transcatheter System (Cardioband) is a marketed system that was approved for treatment of secondary (functional) mitral regurgitation (FMR) (CE granted on September 2015). The Cardioband is an annuloplasty band that is similar to a surgical annuloplasty, however deployed on the beating heart through a transvenous approach. The CE mark study with 30 subjects has been completed and documented significant reduction of severity of MR and improvement in quality of life by Minnesota living with heart failure questionnaire (MLHFQ), New York Heart Association (NYHA) and 6- minute walk test (6MWT), in subjects with moderate to severe MR. The aim of the current study is to evaluate the Cardioband annuloplasty system for repair the Tricuspid Regurgitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardioband Tricuspid procedure | Other | Device: Cardioband TricuspidTricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Chronic functional tricuspid regurgitation (FTR) with annular diameter ≥ 40 mm with valve Systolic pulmonary pressure (sPAP) ≤ 60mmHg
- ≥18 years old
- New York Heart Association (NYHA) Class II-IVa
- Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen
- LVEF ≥ 30%
Key exclusion criteria (27 listed)
- Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation ≥ moderate
- Severe uncontrolled hypertension (Systolic BP ≥ 180 mmHg and/or Diastolic BP ≥ 110 mm Hg)
- Previous tricuspid valve repair or replacement
- Trans-tricuspid pacemaker or defibrillator leads suggesting impingement of the of the tricuspid valve leaflets, as evaluated by echocardiography
- Active endocarditis
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 |
|---|---|---|
| Cardioband TricuspidThe Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance. | Device | Cardioband Tricuspid procedure |
Primary outcome
Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE)
Time frame: 30 days
Overall rate of Major Serious Adverse Events (MSAEs)* and serious adverse device effects (SADE)
Access, Deployment and Positioning of the Cardioband Device
Time frame: Intra-procedure
Successful access, deployment and positioning of the Cardioband device
26 secondary outcomes
Technical Success
Time frame: 1, 6, 12, and 24 months
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Time frame: 1, 6, 12, and 24 months over baseline
Tricuspid Regurgitation [Full Analysis Data Set]
Time frame: 1, 6, 12, and 24 months over baseline
Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]
Time frame: 1, 6, 12, and 24 months over baseline
Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set]
Time frame: 1, 6, 12, and 24 months over baseline
Regurgitant Volume [Paired Baseline and Follow-Up]
Time frame: 1, 6, 12, and 24 months over baseline
Regurgitant Volume [Full Analysis Data Set]
Time frame: 1, 6, 12, and 24 months over baseline
TAPSE [Paired Baseline and Follow-Up]
Time frame: 1, 6, 12, and 24 months over baseline
TAPSE [Full Analysis Data Set]
Time frame: 1, 6, 12, and 24 months over baseline
NYHA [Paired Baseline and Follow-Up]
Time frame: 1, 6, 12, and 24 months over baseline
NYHA [Full Analysis Data Set]
Time frame: 1, 6, 12, and 24 months over baseline
6MWT [Paired Baseline and Follow-Up]
Time frame: 1, 6, 12, and 24 months over baseline
6MWT [Full Analysis Data Set]
Time frame: 1, 6, 12, and 24 months over baseline
Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]
Time frame: 1, 6, 12, and 24 months over baseline
Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set]
Time frame: 1, 6, 12, and 24 months over baseline
Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]
Time frame: 1, 6, 12, and 24 months over baseline
Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set]
Time frame: 1, 6, 12, and 24 months over baseline
Left Ventricle End Diastolic Volume Index (LVEDVI) [Full Analysis Data Set]
Time frame: 1, 6, 12, and 24 months over baseline
Left Ventricle End Systolic Volume Index (LVESVI) [Full Analysis Data Set]
Time frame: 1, 6, 12, and 24 months over baseline
NT-pro BNP [Full Analysis Data Set]
Time frame: 1, 6, 12, and 24 months over baseline
Diuretic Therapy
Time frame: 1, 6, 12, and 24 months over baseline
Bilirubin [Full Analysis Data Set]
Time frame: 1, 6, 12, and 24 months over baseline
Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set]
Time frame: 1, 6, 12, and 24 months over baseline
Activity by Wearable Device
Time frame: 1, 6, 12, and 24 months over baseline
Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set]
Time frame: 1, 6, 12, and 24 months over baseline
Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set]
Time frame: 1, 6, 12, and 24 months over baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33046437Nickenig G, Weber M, Schuler R, Hausleiter J, Nabauer M, von Bardeleben RS, Sotiriou E, Schafer U, Deuschl F, Alessandrini H, Kreidel F, Juliard JM, Brochet E, Latib A, Montorfano M, Agricola E, Baldus S, Friedrichs KP, Deo SH, Gilmore SY, Feldman T, Hahn RT, Maisano F. Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study. EuroIntervention. 2021 Feb 5;16(15):e1264-e1271. doi: 10.4244/EIJ-D-20-01107.
- Derived from this study: PubMed 30999993Nickenig G, Weber M, Schueler R, Hausleiter J, Nabauer M, von Bardeleben RS, Sotiriou E, Schafer U, Deuschl F, Kuck KH, Kreidel F, Juliard JM, Brochet E, Latib A, Agricola E, Baldus S, Friedrichs K, Vandrangi P, Verta P, Hahn RT, Maisano F. 6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation. J Am Coll Cardiol. 2019 Apr 23;73(15):1905-1915. doi: 10.1016/j.jacc.2019.01.062.
- Individual participant dataSharing planned: No
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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.
Georg Nickenig, MD principal investigator
University Hospital, Bonn
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardioband Tricuspid in people with Tricuspid Valve Insufficiency and Tricuspid Regurgitation, run by Edwards Lifesciences at 8 sites in 3 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 8 inclusion and 27 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 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, France, Italy. 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?
Yes. Results are posted in the registry (first posted 28 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE) (time frame: 30 days). The study lists 2 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 NCT02981953, which also lists 2 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 28 Jun 2021.