Tricuspid RegurgitationPhase 1PREVENTNCT02098200
Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™
A Phase 1 study testing TriCinch System in people with Tricuspid Regurgitation, run by 4Tech Cardio Ltd. at 14 sites in 4 countries.
Trial summary
The TriCinch System™ is intended for percutaneous treatment of tricuspid regurgitation. It is a percutaneous catheter-based device designed for tricuspid valve repair in order to decrease effective cross-sectional area and relieve symptoms in patients with tricuspid valve regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- TriCinch System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 14 sitesin 4 countries
- Study dates
- Jun 2013to Oct 2017
- Phase
- Phase 1
- 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
- Functional symptomatic tricuspid regurgitation (TR) 2+ to 4+ on a scale of 4+ (moderate to severe), with annular dilatation greater than 40mm.
- Signed informed consent form prior to any study-related procedure.
- Available and able to return to the study site for post-procedural follow-up examination
- Eighteen (18) years of age or older.
Who cannot join
- Requirement for concomitant cardiac procedure (other than atrial fibrillation correction surgery, closure of PFO (Patent Foramen Ovale) or ASD (Atrial Septal Defect), or PTCA (percutaneous treatment of coronary artery) or CAD (coronary artery bypass surgery) from 1 to 3 months after or before other procedure.
- Presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year.
- Cerebro-vascular event within the past 6 months.
- History of mitral/tricuspid endocarditis within the last 12 months.
- Organic tricuspid disease.
- Contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated.
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- Severe hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg, measurement done by sphygmomanometer with stethoscope, allow the patient to sit for at least 5 minutes before beginning BP measurements).
- Female patient is pregnant (urine HCG test result positive) or lactating.
- Known alcohol or drug abuser.
- Currently participating in the study of an investigational drug or device.
- At heart team's judgement, patient IVC dimension is not adequate for device implantation.
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Italy7 sites
Ferrarotto Hospital
Catania, 95124
Fondazione Toscana G. Monasterio Ospedale del Cuore G. Pasquinucci
Massa, 54100
Monzino Hospital
Milan, Lombardy, 20121
San Raffaele Hospital
Milan, 20129
Azienda Ospedaliera di Padova
Padova, 35128
University Hospital Pisa
Pisa, Tuscany, 56124
Fondazione PTV Policlinico Tor Vergata
Roma
France3 sites
Hospices Civils de Lyon
Lyon
Bichat Hospital
Paris, Paris Cedex 18, 75877
Clinique Pasteur
Toulouse, 31076
Germany3 sites
Universitatsklinikum Bonn
Bonn, 53127
CardioVasculares Centrum Frankfurt
Frankfurt am Main, 60389
UKE Heart Center
Hamburg
About this study
The TriCinch System™ is intended for percutaneous treatment of tricuspid regurgitation.
It is a percutaneous catheter-based device designed for tricuspid valve repair in order to decrease effective cross-sectional area and relieve symptoms in patients with tricuspid valve regurgitation.
Read the detailed description
Implantation Procedure: Unlike the standard open chest, arrested heart approach, the 4TECH TriCinch System™ provides a percutaneous solution for tricuspid valve regurgitation treatment: this procedure is performed through deep sedation, while the heart is beating, without the need for respiratory assistance.
The TriCinch System™ consists of a Delivery System that enables transcatheter placement of an implant that can be adjusted to correct Tricuspid valve regurgitation. The TriCinch Delivery System is inserted from the femoral vein to access the right atrium of the heart. At the end of the correction process, the TriCinch Delivery System and the venous introducer are removed and the procedure is concluded.
- Conditions
- Tricuspid Regurgitation
- Being tested
- TriCinch System
- Keywords
- tricuspid, regurgitation, repair, outcomes
- Medical subject headings
- Tricuspid Valve Insufficiency, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriCinch SystemDevice
Percutaneous treatment of Tricuspid Regurgitation
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous treatment of TR by TriCinch | Experimental | Percutaneous treatment of Tricuspid Regurgitation with TriCinch System Receives: Device: TriCinch System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: The percentage of participants with Major Adverse Events within 30 days of the procedure.
Freedom from major adverse event: death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed TriCinch implantation, stroke, or septicaemia.
Measured: Up to 30 days
Performance: The reduction in degree of tricuspid regurgitation measured immediately after the procedure compared to baseline.
Ability to reduce tricuspid regurgitation by at least 1 degree immediately following implantation of the TriCinch device assessed by means of quantitative echocardiographic parameters.
Measured: intraoperative
Performance: The reduction in the degree of tricuspid regurgitation measured at time of discharge compared to baseline.
Ability to reduce tricuspid regurgitation by at least 1 degree immediately following implantation of the TriCinch device assessed by means of quantitative echocardiographic parameters.
Measured: Time of discharge - 5 days
Secondary outcomes (4)
Safety: The percentage of participants with Major Adverse Events up to 3 months of the procedure.
Rate of device-related major adverse event (MAE).
Measured: 3 months
Safety: The percentage of participants with Major Adverse Events within 6 months of the procedure.
Rate of device-related Major Adverse Event (MAE).
Measured: 6 months
Performance: Assessment in the degree of Tricuspid Regurgitation at 3 months compared to baseline.
Ability to maintain Tricuspid Regurgitation with respect to baseline.
Measured: 3 months
Performance: Assessment in the degree of Tricuspid Regurgitation at 6 months compared to baseline.
Ability to maintain Tricuspid Regurgitation with respect to baseline.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startJun 2013
- Primary completionNov 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4Tech Cardio Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Colombo, MD, Principal investigator, San Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098200
- Sponsor's protocol ID
- PREVENT_001/2013
- Acronym
- PREVENT
- Status last verified
- Mar 2018
- First submitted
- 13 Mar 2014
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™
- ClinicalTrials.gov ID
- NCT02098200
- Acronym / sponsor ID
- PREVENT / PREVENT_001/2013
- Conditions
- Tricuspid Regurgitation
- Keywords
- tricuspid, regurgitation, repair, outcomes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- 4Tech Cardio Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 27 Mar 2014 (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 TriCinch System™ is intended for percutaneous treatment of tricuspid regurgitation.
It is a percutaneous catheter-based device designed for tricuspid valve repair in order to decrease effective cross-sectional area and relieve symptoms in patients with tricuspid valve regurgitation.
Detailed description
Implantation Procedure: Unlike the standard open chest, arrested heart approach, the 4TECH TriCinch System™ provides a percutaneous solution for tricuspid valve regurgitation treatment: this procedure is performed through deep sedation, while the heart is beating, without the need for respiratory assistance.
The TriCinch System™ consists of a Delivery System that enables transcatheter placement of an implant that can be adjusted to correct Tricuspid valve regurgitation. The TriCinch Delivery System is inserted from the femoral vein to access the right atrium of the heart. At the end of the correction process, the TriCinch Delivery System and the venous introducer are removed and the procedure is concluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous treatment of TR by TriCinch | Experimental | Device: TriCinch SystemPercutaneous treatment of Tricuspid Regurgitation with TriCinch System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Functional symptomatic tricuspid regurgitation (TR) 2+ to 4+ on a scale of 4+ (moderate to severe), with annular dilatation greater than 40mm.
- Signed informed consent form prior to any study-related procedure.
- Available and able to return to the study site for post-procedural follow-up examination
- Eighteen (18) years of age or older.
Key exclusion criteria (11 listed)
- Requirement for concomitant cardiac procedure (other than atrial fibrillation correction surgery, closure of PFO (Patent Foramen Ovale) or ASD (Atrial Septal Defect), or PTCA (percutaneous treatment of coronary artery) or CAD (coronary artery bypass surgery) from 1 to 3 months after or before other procedure.
- Presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year.
- Cerebro-vascular event within the past 6 months.
- History of mitral/tricuspid endocarditis within the last 12 months.
- Organic tricuspid disease.
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 |
|---|---|---|
| TriCinch SystemPercutaneous treatment of Tricuspid Regurgitation | Device | Percutaneous treatment of TR by TriCinch |
Primary outcome
Safety: The percentage of participants with Major Adverse Events within 30 days of the procedure.
Time frame: Up to 30 days
Freedom from major adverse event: death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed TriCinch implantation, stroke, or septicaemia.
Performance: The reduction in degree of tricuspid regurgitation measured immediately after the procedure compared to baseline.
Time frame: intraoperative
Ability to reduce tricuspid regurgitation by at least 1 degree immediately following implantation of the TriCinch device assessed by means of quantitative echocardiographic parameters.
Performance: The reduction in the degree of tricuspid regurgitation measured at time of discharge compared to baseline.
Time frame: Time of discharge - 5 days
Ability to reduce tricuspid regurgitation by at least 1 degree immediately following implantation of the TriCinch device assessed by means of quantitative echocardiographic parameters.
4 secondary outcomes
Safety: The percentage of participants with Major Adverse Events up to 3 months of the procedure.
Time frame: 3 months
Safety: The percentage of participants with Major Adverse Events within 6 months of the procedure.
Time frame: 6 months
Performance: Assessment in the degree of Tricuspid Regurgitation at 3 months compared to baseline.
Time frame: 3 months
Performance: Assessment in the degree of Tricuspid Regurgitation at 6 months compared to baseline.
Time frame: 6 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 14 Mar 2018.
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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.
Antonio Colombo, MD principal investigator
San Raffaele Hospital
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TriCinch System in people with Tricuspid Regurgitation, run by 4Tech Cardio Ltd. at 14 sites in 4 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 4 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 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy, France, Germany, Netherlands. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Safety: The percentage of participants with Major Adverse Events within 30 days of the procedure. (time frame: Up to 30 days). 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?
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 14 Mar 2018.