Tricuspid RegurgitationNCT05179616
Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair
An observational study of Tricuspid Regurgitation and Right Heart Failure, run by Helios Klinikum Pforzheim at 1 site in Germany.
Trial summary
The Pforzheim Tricuspid Valve Registry study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting in critically ill patients. The observational trial is a prospective, single arm, open-label, single-center, post market registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation, Right Heart Failure, Cardiac Remodeling, Ventricular
- What is being tested?
- Transcatheter edge-to-edge tricuspid valve repair
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 30 Nov 2020to 30 Nov 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All subjects who have symptomatic severe tricuspid regurgitation despite medical therapy and are eligible to receive the TriClip™
Who may be able to join
- Subjects (>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy.
- Subjects eligible to receive the TriClip™
- Subjects must provide written informed consent prior to study procedure.
Who cannot join
- Subjects participating in another clinical study that may impact the follow-up or results of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Helios Klinikum Pforzheim
Pforzheim, 75175
Alexandru Patrascu, MD, +491736964480, alexbasket23@yahoo.com
About this study
Official title: Pforzheim Tricuspid Valve Registry: A Real-world Observational Trial Evaluating Outcomes in Patients Treated With the Abbott TriClip™ Device in Helios Klinikum Pforzheim
The Pforzheim Tricuspid Valve Registry study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting in critically ill patients. The observational trial is a prospective, single arm, open-label, single-center, post market registry.
Read the detailed description
Significant tricuspid regurgitation is a common finding in elderly patients, with an incidence of 5.6% after the age of 70 years, according to the Framingham Heart Study. TR is an independent predictor for adverse prognosis and has limited treatment options. Tricuspid valve (TV) intervention is indicated when symptomatic TR-related right heart failure (RHF) is present. However, the surgical risk is usually deemed to be too high due to the presence of advanced age, pulmonary hypertension, right ventricular (RV) impairment, major organ failure and other co-morbidities. Moreover, isolated tricuspid valve surgery has an in-hospital mortality of approx. 8,7%, according to recent data.
High TR prevalence, coupled with low incidence of isolated TV surgery, has created a considerable population in need of alternative, percutaneous therapies to improve outcomes. Recently, a variety of interventional procedures and devices have been developed which simulate different surgical approaches like suture or ring annuloplasty, coaptation enhancement, neochordae repair, or even valve replacement. Among them, coaptation devices attempt to correct leaflet malcoaptation by using the edge-to-edge clip technique, similar to treatment of functional mitral regurgitation. To date, most TTVR interventions have been performed off-label with the MitraClip device.
Last year, the first TR dedicated device (TriClipTM, Abbott Medical) has been approved (CE mark), after showing good feasibility, safety and effectiveness, and meanwhile sustained and marked clinical benefit with low mortality after 12 months.
Although most TTVR studies have enrolled high-risk cohorts, criteria for patient selection and timing of intervention have yet to be defined. Based on scientific surgical data, it seems reasonable to expect poorer outcomes in patients with several comorbidities, advanced cardiac remodeling and RHF-related major organ dysfunction e.g., renal and hepatic function impairment. Whether or not this assumption can be extrapolated to TTVR needs to be investigated.
In this registry, the investigators aim to evaluate if percutaneous therapy with the TriClip system is safe and effective in patients at high and prohibitive risk and wether or not procedural success is the main determinant of short-, mid- and long-term outcomes.
- Conditions
- Tricuspid Regurgitation, Right Heart Failure, Cardiac Remodeling, Ventricular, Cardiac Remodeling, Atrial
- Being tested
- Transcatheter edge-to-edge tricuspid valve repair
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Failure, Ventricular Remodeling, Atrial Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter edge-to-edge tricuspid valve repairProcedure or surgery
Percutaneous edge to edge repair of tricuspid valve using the TriClip system
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Patients | Patients suffering from symptoms of right heart failure due to high-grade tricuspid regurgitation Receives: Procedure: Transcatheter edge-to-edge tricuspid valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
One-grade reduction of tricuspid regurgitation
Measured: at 12 months
Secondary outcomes (3)
Change in quality of life
NYHA class
Measured: at 12 months
Change in functional capacity
6-minute walk test
Measured: at 12 months
Major organ system functional change
Renal and hepatic function as assessed by following lab values: creatinine, glomerular filtration rate, aspartate transaminase, alanine aminotransferase and bilirubine
Measured: at12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start30 Nov 2020
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2026 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Helios Klinikum Pforzheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrascu Alexandru, Helios Klinikum Pforzheim
- Investigators
- Ilka Ott, MD, PhD, Principal investigator, Helios Klinikum Pforzheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179616
- Sponsor's protocol ID
- PF-TriValve
- Status last verified
- Sep 2023
- First submitted
- 27 Nov 2021
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pforzheim Tricuspid Valve Registry: A Real-world Observational Trial Evaluating Outcomes in Patients Treated With the Abbott TriClip™ Device in Helios Klinikum Pforzheim
- ClinicalTrials.gov ID
- NCT05179616
- Acronym / sponsor ID
- PF-TriValve
- Conditions
- Tricuspid Regurgitation, Right Heart Failure, Cardiac Remodeling, Ventricular, Cardiac Remodeling, Atrial
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Helios Klinikum PforzheimUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 5 Jan 2022 (actual)
- 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 Pforzheim Tricuspid Valve Registry study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting in critically ill patients. The observational trial is a prospective, single arm, open-label, single-center, post market registry.
Detailed description
Significant tricuspid regurgitation is a common finding in elderly patients, with an incidence of 5.6% after the age of 70 years, according to the Framingham Heart Study. TR is an independent predictor for adverse prognosis and has limited treatment options. Tricuspid valve (TV) intervention is indicated when symptomatic TR-related right heart failure (RHF) is present. However, the surgical risk is usually deemed to be too high due to the presence of advanced age, pulmonary hypertension, right ventricular (RV) impairment, major organ failure and other co-morbidities. Moreover, isolated tricuspid valve surgery has an in-hospital mortality of approx. 8,7%, according to recent data.
High TR prevalence, coupled with low incidence of isolated TV surgery, has created a considerable population in need of alternative, percutaneous therapies to improve outcomes. Recently, a variety of interventional procedures and devices have been developed which simulate different surgical approaches like suture or ring annuloplasty, coaptation enhancement, neochordae repair, or even valve replacement. Among them, coaptation devices attempt to correct leaflet malcoaptation by using the edge-to-edge clip technique, similar to treatment of functional mitral regurgitation. To date, most TTVR interventions have been performed off-label with the MitraClip device.
Last year, the first TR dedicated device (TriClipTM, Abbott Medical) has been approved (CE mark), after showing good feasibility, safety and effectiveness, and meanwhile sustained and marked clinical benefit with low mortality after 12 months.
Although most TTVR studies have enrolled high-risk cohorts, criteria for patient selection and timing of intervention have yet to be defined. Based on scientific surgical data, it seems reasonable to expect poorer outcomes in patients with several comorbidities, advanced cardiac remodeling and RHF-related major organ dysfunction e.g., renal and hepatic function impairment. Whether or not this assumption can be extrapolated to TTVR needs to be investigated.
In this registry, the investigators aim to evaluate if percutaneous therapy with the TriClip system is safe and effective in patients at high and prohibitive risk and wether or not procedural success is the main determinant of short-, mid- and long-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Patients | – | Procedure: Transcatheter edge-to-edge tricuspid valve repairPatients suffering from symptoms of right heart failure due to high-grade tricuspid regurgitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who have symptomatic severe tricuspid regurgitation despite medical therapy and are eligible to receive the TriClip™
Key inclusion criteria (3 listed)
- Subjects (>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy.
- Subjects eligible to receive the TriClip™
- Subjects must provide written informed consent prior to study procedure.
Key exclusion criteria (1 listed)
- Subjects participating in another clinical study that may impact the follow-up or results of this study.
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 |
|---|---|---|
| Transcatheter edge-to-edge tricuspid valve repairPercutaneous edge to edge repair of tricuspid valve using the TriClip system | Procedure or surgery | Heart Failure Patients |
Primary outcome
Procedural Success
Time frame: at 12 months
One-grade reduction of tricuspid regurgitation
3 secondary outcomes
Change in quality of life
Time frame: at 12 months
Change in functional capacity
Time frame: at 12 months
Major organ system functional change
Time frame: at12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Tricuspid Regurgitation
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
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TRI-SUCCESS - Tricuspid Regurgitation Study of the Unica™ Cross-Caval System for the Evaluation of Efficacy and Safety in Significant TR Subjects
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Recruiting
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
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Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
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.
Ilka Ott, MD, PhD principal investigator
Helios Klinikum Pforzheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Regurgitation and Right Heart Failure, run by Helios Klinikum Pforzheim 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 Sep 2023. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilka Ott, MD, PhD (+4972319692955, Ilka.Ott@helios-pforzheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Success (time frame: at 12 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 22 Sep 2023.