Severe Tricuspid Valve Regurgitation (Disorder)NCT05045079
Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation
A study testing Inferior Vena Caval (IVC) Occlusion maneuver in people with Severe Tricuspid Valve Regurgitation (Disorder), run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to understand the clinical impact of non-surgical and surgical treatment in atrial fibrillation induced tricuspid regurgitation (AFTR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Tricuspid Valve Regurgitation (Disorder)
- What is being tested?
- Inferior Vena Caval (IVC) Occlusion maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2022to 9 Aug 2023
- 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
- Age ≥ 18 years.
- Moderate-severe or severe TR while in atrial fibrillation.
- Ambulatory (not wheelchair/scooter dependent).
Who cannot join
- Systolic pulmonary artery pressure>70 mmHg with a fixed pulmonary vascular resistance >7 Wood units by catheterization.
- Ejection fraction <40%.
- Obstructive hypertrophic cardiomyopathy.
- Constrictive pericarditis or tamponade.
- Active myocarditis.
- Complex congenital heart disease.
Show all 9Show fewer
- Other valve disease requiring surgical intervention.
- Terminal illness (other than HF) with expected survival of less than 1 year.
- Pregnancy or breastfeeding mothers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Tricuspid Regurgitation Due to Atrial Fibrillation - Impact of Rhythm Control and Early Surgery (TR-ES Study)
The purpose of this study is to understand the clinical impact of non-surgical and surgical treatment in atrial fibrillation induced tricuspid regurgitation (AFTR).
- Being tested
- Inferior Vena Caval (IVC) Occlusion maneuver
- 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.
Inferior Vena Caval (IVC) Occlusion maneuverProcedure or surgery
During standard of care right heart catheterization (RHC), a second catheter will be inserted next to the catheter that was placed for the RHC in the jugular vein or femoral vein to assess the degree of pericardial restraint from the severe tricuspid regurgitation that may increase left sided filling pressures.
| Study group | Role | What they receive |
|---|---|---|
| Severe tricuspid regurgitation due to atrial fibrillation | Other | Subjects will receive standard of care procedure right heart catheterization with a inferior vena caval (IVC) occlusion maneuver. Receives: Procedure: Inferior Vena Caval (IVC) Occlusion maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in KCCQ QOL scores
The KC Cardiomyopathy Questionnaire (0-100 scale) assess subject perception of heart failure limitation on their life; scale of extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, limited for other reasons or did not do the activity.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start20 Jan 2022
- Primary completion9 Aug 2023
- Study completion9 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Tricuspid Valve Regurgitation (Disorder)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yogesh Reddy, Mayo Clinic
- Investigators
- Yogesh Reddy, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045079
- Sponsor's protocol ID
- 21-000537
- Status last verified
- May 2024
- First submitted
- 7 Sep 2021
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tricuspid Regurgitation Due to Atrial Fibrillation - Impact of Rhythm Control and Early Surgery (TR-ES Study)
- ClinicalTrials.gov ID
- NCT05045079
- Acronym / sponsor ID
- 21-000537
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 16 Sep 2021 (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 purpose of this study is to understand the clinical impact of non-surgical and surgical treatment in atrial fibrillation induced tricuspid regurgitation (AFTR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe tricuspid regurgitation due to atrial fibrillation | Other | Procedure: Inferior Vena Caval (IVC) Occlusion maneuverSubjects will receive standard of care procedure right heart catheterization with a inferior vena caval (IVC) occlusion maneuver. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Moderate-severe or severe TR while in atrial fibrillation.
- Ambulatory (not wheelchair/scooter dependent).
Key exclusion criteria (9 listed)
- Systolic pulmonary artery pressure>70 mmHg with a fixed pulmonary vascular resistance >7 Wood units by catheterization.
- Ejection fraction <40%.
- Obstructive hypertrophic cardiomyopathy.
- Constrictive pericarditis or tamponade.
- Active myocarditis.
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 |
|---|---|---|
| Inferior Vena Caval (IVC) Occlusion maneuverDuring standard of care right heart catheterization (RHC), a second catheter will be inserted next to the catheter that was placed for the RHC in the jugular vein or femoral vein to assess the degree of pericardial restraint from the severe tricuspid regurgitation that may increase left sided filling pressures. | Procedure or surgery | Severe tricuspid regurgitation due to atrial fibrillation |
Primary outcome
Change in KCCQ QOL scores
Time frame: Baseline, 6 months
The KC Cardiomyopathy Questionnaire (0-100 scale) assess subject perception of heart failure limitation on their life; scale of extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, limited for other reasons or did not do the activity.
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 21 May 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Severe Tricuspid Valve Regurgitation (Disorder)
Recruiting
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
Active, not recruiting
TRISCEND JAPAN Study
Tricuspid Valve Regurgitation, Heart Valve Diseases
Recruiting
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
Recruiting
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR)
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.
Yogesh Reddy, MBBS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior Vena Caval (IVC) Occlusion maneuver in people with Severe Tricuspid Valve Regurgitation (Disorder), run by Mayo Clinic at 1 site in United States.
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 9 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 21 May 2024. 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 United States. 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?
Change in KCCQ QOL scores (time frame: Baseline, 6 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 21 May 2024.