TriClip Procedure for Severe Tricuspid Regurgitation

The TriClip procedure is a catheter-based treatment that clips together the leaflets of a leaking tricuspid valve to reduce backward blood flow in the heart. Approved by the FDA in 2024, it is designed for people with severe tricuspid regurgitation who are too sick or too high-risk for open-heart surgery. The tricuspid valve sat in the shadows of cardiology for decades, but a growing body of trial data and real-world experience has made TriClip the first transcatheter device to offer a proven alternative to either surgery or simply living with the leak on medications.

What the Tricuspid Valve Does and Why It Leaks

The tricuspid valve sits between the right atrium and right ventricle, controlling blood flow toward the lungs. When it fails to close properly, blood washes backward with every heartbeat. Over time this volume overload stretches the right side of the heart, leads to fluid buildup in the legs and abdomen, and causes progressive fatigue and shortness of breath. The condition, called tricuspid regurgitation, affects millions of people worldwide, and severe cases carry a poor prognosis when left untreated.

For most patients, the leak is not caused by a problem with the valve leaflets themselves. Instead, the valve ring stretches because the right ventricle or right atrium has dilated from other conditions like heart failure, atrial fibrillation, or pulmonary hypertension. This “functional” or “secondary” regurgitation makes the valve’s three leaflets unable to meet in the middle, leaving a gap through which blood escapes. In some patients, pacemaker or defibrillator leads running through the valve physically interfere with leaflet closure, adding another layer of complexity.

Historically, the tricuspid valve earned the nickname “the forgotten valve” because surgeons often avoided isolated tricuspid surgery due to high operative mortality, and the condition was thought to resolve if the underlying left-sided heart disease was treated.¹ That assumption turned out to be wrong for many patients, creating a large population with severe, symptomatic tricuspid regurgitation and no good treatment options until transcatheter therapies arrived.

How the TriClip Procedure Works

TriClip is an edge-to-edge repair device, meaning it works by fastening adjacent valve leaflets together at the point where the leak is worst. The concept borrows from a surgical technique, but everything happens through a catheter inserted in a vein in the groin. No chest incision, no heart-lung bypass machine, and no stopping the heart.

The procedure begins with venous access through the femoral vein using a large-bore sheath. A specially designed steerable guide catheter is advanced up through the inferior vena cava into the right atrium. From there, the operator steers the catheter across the tricuspid valve into the right ventricle under a combination of echocardiographic imaging and X-ray fluoroscopy.² The clip is opened in the ventricle, positioned at the site of maximum regurgitation, and then pulled back to grasp the leaflet edges. Once the leaflets are captured and the leak is confirmed to have decreased on imaging, the clip is deployed and the catheter is withdrawn.

The device itself has evolved through several generations. The current G4 platform offers multiple clip sizes and the ability to grasp each leaflet independently rather than grabbing both at once, which gives the operator more control over the capture and lets them fine-tune placement before committing.³ In many cases, more than one clip is placed to further reduce the leak. The anterior and septal leaflets are the pair most commonly clipped together.

Anesthetic management during the procedure requires careful heart rate control. Operators generally want a rate in the range of 60 to 80 beats per minute during clipping, and if multiple clips are needed, the rate is gradually lowered in small increments to give the team a steadier target.⁴ General anesthesia is standard because a transesophageal echocardiography probe needs to be in the esophagus throughout the case for imaging guidance.

Why the Tricuspid Valve Is Harder to Clip Than the Mitral

TriClip is adapted from the MitraClip platform, which treats mitral regurgitation on the left side of the heart. But the tricuspid valve poses distinct engineering challenges. Under normal conditions it can have an opening area of up to 9 square centimeters, and in the presence of functional regurgitation that orifice dilates further. The regurgitant gap is frequently larger than 1 square centimeter, more than double what is typical for mitral regurgitation, and the coaptation gap between leaflets can be wide.⁵ The valve also has three leaflets instead of two, which means the geometry of the leak is more variable and the operator may need to clip across more than one pair of leaflets.

These anatomical realities are a big part of why complete elimination of regurgitation is not always possible with edge-to-edge repair. The goal is meaningful reduction, usually to moderate or less, rather than zero leak. That partial fix can still be transformative for symptoms and quality of life, but it is a different benchmark than what cardiologists are accustomed to with mitral repair.

What the Clinical Trials Show

The pivotal evidence for TriClip comes from the TRILUMINATE trial program. The early single-arm feasibility study showed that at six months, the rate of major adverse events was about 6%, well under the safety threshold that had been set in advance. No deaths occurred during or immediately after the procedure, and there were no device embolizations or strokes.⁶

The randomized phase compared TriClip plus medical therapy to medical therapy alone. At 30 days, roughly 87 to 89% of patients in the device group had their regurgitation reduced to moderate or less, compared with about 5% in the control group.⁷ At one year, the device group showed a meaningful improvement in quality of life scores and walked farther on a standardized six-minute test, while the control group showed no change or slight decline.⁸ At two years, about 84% of device patients still had moderate or less regurgitation, suggesting the repair is reasonably durable in the medium term.⁹

One important caveat: the trial’s primary composite endpoint at one year included both death and a measure of tricuspid regurgitation severity, and it did not hit a traditional threshold for statistical superiority when analyzed on an intention-to-treat basis. This generated debate in the cardiology community. The secondary endpoints, particularly quality of life and functional capacity, told a more convincing story of clinical benefit. That quality-of-life data has been a major driver of clinical adoption.

How Patients Actually Feel Afterward

For many patients with severe tricuspid regurgitation, the daily burden of the disease is enormous: swollen legs, abdominal bloating, inability to walk more than a short distance, and constant fatigue. A dedicated analysis of health status from the TRILUMINATE trial found that TriClip patients were substantially more likely to be “alive and well” at one year than those on medications alone. About 75% of device patients met that threshold versus roughly 46% in the medical therapy group, translating to a number needed to treat of about 3.5, meaning that for roughly every four patients treated, one additional patient was alive and feeling well who otherwise would not have been.¹⁰

Earlier single-arm studies also found marked functional gains. In one study, the proportion of patients in milder symptom classes jumped from about 31% before the procedure to 83% afterward, and six-minute walk distances improved by about 30 meters on average.¹¹ These are not abstract metrics. A gain of 30 meters on a walk test can be the difference between managing a grocery trip and not.

Who Is a Good Candidate

Not everyone with a leaking tricuspid valve is suitable for TriClip. Patient selection depends heavily on the anatomy of the valve, and detailed imaging with transesophageal echocardiography is essential to determine whether the leaflets can be clipped.¹² A study of nearly 500 patients found that about 20% had anatomy considered favorable, another 48% had feasible anatomy, and roughly 32% had anatomy unfavorable for edge-to-edge repair. The most common disqualifying features were a large coaptation gap between leaflets, found in about two-thirds of unfavorable cases, and a jet location between the anterior and posterior leaflets rather than the more accessible anterior-septal pair.¹³

Imaging studies from the bRIGHT registry characterized these coaptation gaps in detail. Interestingly, the degree of short-term regurgitation reduction was similar whether the gap measured less than 7 millimeters, 7 to 10 millimeters, or more than 10 millimeters, suggesting that experienced operators can achieve meaningful results across a range of anatomies.¹⁴ Still, the bottom line is that a thorough echocardiographic evaluation is non-negotiable before proceeding.

Real-World Results Outside of Trials

Clinical trials enroll carefully selected patients, so what happens when TriClip is used in routine practice matters. The bRIGHT real-world registry confirmed that the procedure was safe and effective through one year in a diverse population that included sicker patients than those typically enrolled in randomized trials.¹⁵ A multicenter registry from Spain similarly reported an intraprocedural success rate of about 79%, with in-hospital mortality of roughly 1.4%.¹⁶

These real-world numbers are slightly lower than the randomized trial success rates, which is expected when a broader and more complex patient population is treated. They still demonstrate that the procedure translates well outside the controlled research environment.

Patients With Pacemaker or Defibrillator Leads

A large subset of people with significant tricuspid regurgitation have pacemaker or defibrillator leads crossing through the valve. In the bRIGHT registry, about one in five enrolled patients had an endocardial lead, and in about 81% of those cases the lead was thought to be at least partly contributing to the regurgitation.¹⁷ At 30 days, about 71% of patients with leads had regurgitation reduced to moderate or less, their functional status improved markedly, and no lead malfunctions were reported. Complication rates were similar to those in patients without leads. These results are reassuring, since the presence of a lead was once considered a relative contraindication to any tricuspid intervention. The approach does need to be tailored to each patient’s specific anatomy and lead position.¹⁸

How TriClip Compares to Open Surgery

The question patients and referring doctors often ask is whether TriClip is as good as surgical repair. A comparative study adjusting for baseline differences found no significant difference in two-year survival between the two approaches. Where TriClip clearly wins is in the short term: in-hospital mortality was about 2.5% with TriClip versus 12.5% with surgery, and the need for a new permanent pacemaker after the procedure was essentially zero with TriClip compared to roughly 13% with surgery.¹⁹

The trade-off is durability and completeness of repair. Tricuspid valve reintervention was about eight times more frequent in the TriClip group than in the surgical group over two years. Surgery, when a patient can tolerate it, tends to eliminate the leak more completely and durably. TriClip’s advantage is that many patients with severe tricuspid regurgitation are elderly, frail, or have multiple comorbidities that make open surgery prohibitively risky. For them, a less invasive procedure with a lower up-front risk profile fills a critical gap.

What Happens to the Heart After the Repair

One of the more encouraging findings is that fixing the leak does not just relieve symptoms. It also allows the right ventricle to begin recovering from years of volume overload. Imaging studies have documented a two-phase process of reverse remodeling. In the first phase, right around discharge, the right ventricle unloads and its end-diastolic volume drops by about 10%. The second phase happens more gradually: over the next six months, the ventricle begins to shrink in systolic dimensions as well, and this structural improvement peaks at about one year and remains stable through two years.²⁰ Exercise-based assessments have shown parallel improvements in right heart function under exertion.²¹ This reverse remodeling is a strong signal that the procedure changes the disease trajectory, not just the symptoms.

Advances in Procedural Imaging

Guiding a clip to a precise spot on a beating valve deep in the chest requires excellent real-time imaging. Transesophageal echocardiography has been the workhorse, but the tricuspid valve can be harder to visualize from the esophagus than the mitral valve because of its anterior position in the chest. Three-dimensional intracardiac echocardiography, where a small ultrasound catheter is placed directly inside the heart, has emerged as either an add-on or standalone imaging option for tricuspid procedures.²² In some patients who cannot tolerate a standard transesophageal probe, a miniature 9-millimeter probe has been used successfully to guide TriClip implantation while reducing the risk of esophageal injury.²³ These imaging advances are expanding the procedure’s reach to patients who might previously have been turned away on technical grounds.

Sex Differences in Outcomes and Prognosis

Tricuspid regurgitation is not the same disease in men and women. A study of over 700 patients undergoing transcatheter tricuspid intervention found that men were more likely to have coronary artery disease and a leaking valve driven by ventricular dilation, while women more often had regurgitation caused by atrial dilation, typically from longstanding atrial fibrillation. Despite these differences, two-year survival was similar between the sexes, at about 70% in women and 64% in men.²⁴

Where sex does matter is in risk stratification. The study identified different thresholds for a measure of right heart coupling that predicted worse survival in men versus women. This means a single-number cutoff applied equally to both sexes could misclassify risk. As the field matures, sex-specific risk models may help teams better identify who benefits most and when the window for intervention is closing.

Transcatheter Replacement as an Alternative

TriClip repairs the existing valve, but a separate category of devices replaces the valve entirely with a prosthesis delivered by catheter. Transcatheter tricuspid valve replacement can eliminate regurgitation regardless of how distorted the native anatomy is, which is an advantage when edge-to-edge repair cannot achieve an adequate result.²⁵ However, replacement carries higher rates of pacemaker implantation, bleeding, and right ventricular failure, and patients need lifelong blood-thinning medication afterward.²⁶ Replacement also remains less widely available. The choice between repair and replacement is becoming an increasingly important conversation in heart teams, and decision algorithms are being developed to guide it based on valve anatomy, patient characteristics, and center experience.

Cost and Access Considerations

An economic analysis estimated that TriClip treatment cost roughly €25,700 over five years compared with about €3,900 for medication alone, but the device group had a higher five-year survival rate (about 58% versus 50%) and gained an average of 1.64 additional life years, making it cost-effective by standard health economic criteria.²⁷ That analysis was done before the full TRILUMINATE randomized data were available, so the real-world cost-effectiveness picture may shift as longer-term outcomes accumulate and the procedure becomes more widely adopted.

Access remains uneven. TriClip requires a specialized interventional team, advanced imaging capabilities, and a structural heart program with experience in right-sided interventions. For now, the procedure is concentrated at high-volume academic centers. As operator experience grows and training programs expand, broader availability is expected, but patients in smaller communities may still face travel to receive the treatment.