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Rhythm Control/Surgery for Tricuspid Regurgitation

N/A

Recruiting

Led By Yogesh Reddy, MBBS

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate-severe or severe TR while in atrial fibrillation

Ambulatory (not wheelchair/scooter dependent)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months

Awards & highlights

Study Summary

This trial will compare the effects of surgical and non-surgical treatments for atrial fibrillation-induced tricuspid regurgitation.

Who is the study for?

This trial is for adults over 18 who can walk and have moderate to severe tricuspid regurgitation due to atrial fibrillation. It's not for those with active heart inflammation, complex heart defects, pregnant or breastfeeding women, certain high blood pressure in the lungs, weak heart pumping function, thickened heart muscle blocking blood flow, tightness around the heart from scarring or fluid buildup, other valve diseases needing surgery, or a terminal illness with less than a year to live.Check my eligibility

What is being tested?

The study aims to compare the effects of non-surgical methods versus potential early surgery on patients with tricuspid regurgitation caused by atrial fibrillation. Specifically being tested is an Inferior Vena Caval (IVC) Occlusion maneuver which may influence treatment decisions.See study design

What are the potential side effects?

While specific side effects are not listed for IVC Occlusion maneuvers in this summary, such procedures typically carry risks like discomfort at the site of occlusion and temporary changes in heartbeat rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate to severe tricuspid regurgitation and atrial fibrillation.

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I can walk without the help of a wheelchair or scooter.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in KCCQ QOL scores

Trial Design

1Treatment groups

Experimental Treatment

Group I: Severe tricuspid regurgitation due to atrial fibrillationExperimental Treatment1 Intervention

Subjects will receive standard of care procedure right heart catheterization with a inferior vena caval (IVC) occlusion maneuver.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,212 Previous Clinical Trials

3,767,026 Total Patients Enrolled

Yogesh Reddy, MBBSPrincipal InvestigatorMayo Clinic

Media Library

Severe tricuspid regurgitation due to atrial fibrillation Clinical Trial Eligibility Overview. Trial Name: NCT05045079 — N/A

Tricuspid Regurgitation Research Study Groups: Severe tricuspid regurgitation due to atrial fibrillation

Tricuspid Regurgitation Clinical Trial 2023: Severe tricuspid regurgitation due to atrial fibrillation Highlights & Side Effects. Trial Name: NCT05045079 — N/A

Severe tricuspid regurgitation due to atrial fibrillation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05045079 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity of participants in this experiment?

"Affirmative. Clinicaltrials.gov hosts data which confirms that this medical trial, first posted on January 20th 2022, is actively seeking participants. 12 individuals need to be successfully recruited for the study from a single site."

Answered by AI

Is this experiment accepting new participants?

"According to clinicaltrials.gov, this research study is currently seeking enrolment and has been since its initial posting on January 20th 2022, with the latest update being made May 11th of that same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation

Yogesh Reddy 2022. "Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05045079.

All > Tricuspid Regurgitation