Transcatheter vs Surgical Valve Replacement for Bicuspid Aortic Valve

(BELIEVE-IT Trial)

Overseen By Mitch Gheorghiu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Recent cardiovascular intervention, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Procedure duration

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the better treatment for individuals with severe aortic stenosis, specifically those with a bicuspid aortic valve. Researchers will compare two procedures: Transcatheter Aortic Valve Replacement (TAVR), a less invasive option, and Surgical Aortic Valve Replacement (SAVR), a traditional surgery. Patients will be randomly assigned to one of these treatments to evaluate safety and effectiveness over a ten-year period. The trial seeks participants diagnosed with severe aortic stenosis and a bicuspid aortic valve confirmed by a CT scan. As an unphased trial, it offers participants the chance to contribute to significant research that could enhance treatment options for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Transcatheter Aortic Valve Replacement (TAVR) is safe and effective for treating bicuspid aortic valve stenosis, a narrowing of the valve. Research has found that TAVR achieves a high success rate, with one-year survival rates similar to those of patients with a regular aortic valve. Serious complications are rare, with some studies reporting only 1.3% of patients experiencing issues within 30 days.

Surgical Aortic Valve Replacement (SAVR) also has strong safety evidence, as it is a standard treatment for severe aortic stenosis and has been widely used and studied. Both TAVR and SAVR are common procedures for aortic valve problems. This trial aims to compare them specifically in patients with a bicuspid aortic valve, a less common valve shape. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for bicuspid aortic valve because they offer different approaches to valve replacement. Unlike traditional surgical aortic valve replacement (SAVR), which requires open-heart surgery, transcatheter aortic valve replacement (TAVR) is minimally invasive, involving a catheter to replace the valve. This less invasive method can mean a quicker recovery and less risk for patients who might not be able to withstand major surgery. Both treatments aim to improve long-term heart function, but TAVR's unique delivery method is what sets it apart from the standard surgical option.

What evidence suggests that this trial's treatments could be effective for severe aortic stenosis?

This trial will compare Transcatheter Aortic Valve Replacement (TAVR) with Surgical Aortic Valve Replacement (SAVR) for patients with a narrowed bicuspid aortic valve. Research has shown that TAVR is a promising treatment, with studies indicating a success rate of 96.3% and a low complication rate, with only 1.4% of patients needing another valve procedure within three years. SAVR, on the other hand, has been the traditional method with well-known results. Over five years, studies have found that the risk of death from heart-related issues is similar for both TAVR and SAVR. Both treatments effectively manage severe narrowing of the aortic valve in patients with a bicuspid valve. ^{1 2 4 5 6}

Who Is on the Research Team?

Raj Makkar, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with severe aortic stenosis and bicuspid aortic valve who are suitable for both transcatheter (TAVR) and surgical valve replacement (SAVR). The heart team must approve their participation. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Gated contrast CT available and suitable for core laboratory analysis

Provision of signed and dated informed consent form

My doctor says I need a valve replacement for my severe aortic stenosis.

Exclusion Criteria

Extreme or prohibitive TAVR or SAVR risk, determined by site or committee

Presence of an existing TAVR or SAVR device

Pregnancy or lactation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either Transcatheter Aortic Valve Replacement (TAVR) or Surgical Aortic Valve Replacement (SAVR)

Procedure duration

1 visit (in-person for procedure)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Regular visits as per standard of care

What Are the Treatments Tested in This Trial?

Interventions

• Surgical Aortic Valve Replacement
• Transcatheter Aortic Valve Replacement

Trial Overview The study compares two standard treatments for severe aortic stenosis in patients with bicuspid valves: TAVR, which involves placing the valve via a catheter, versus SAVR, traditional open-heart surgery. Patients will be randomly assigned to one of these treatments.

How Is the Trial Designed?

Group I: transcatheter aortic valve replacement (TAVR) Active Control 1 Intervention

50% of patients will be treated with standard TAVR procedure and followed up for 10 years

Group II: surgical aortic valve replacement (SAVR) Active Control 1 Intervention

50% of patients will be treated with standard SAVR procedure and followed up for 10 years

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Published Research Related to This Trial

In a study of 1023 patients with stenotic bicuspid aortic valve (BAV), transcatheter aortic valve replacement (TAVR) showed comparable device success rates to surgical aortic valve replacement (SAVR) (94.2% vs. 97.1%), indicating TAVR is a viable alternative to surgery.

However, TAVR was associated with a higher incidence of mild-to-severe paravalvular regurgitation (PVR) compared to SAVR (19.4% vs. 7.9%), particularly in certain BAV morphologies, suggesting that while TAVR is effective, careful monitoring for PVR is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter and surgical aortic valve replacement in patients with bicuspid aortic valve. Husso, A., Airaksinen, J., Juvonen, T., et al.[2023]

Only 6.8% of patients with bicuspid aortic valve (BAV) disease underwent transcatheter aortic valve replacement (TAVR), and while TAVR showed higher initial hospitalization mortality compared to surgical aortic valve replacement (SAVR), risk-adjusted analyses indicated no significant difference in overall mortality between the two procedures.

Patients undergoing TAVR had higher rates of pacemaker implantation and reintervention compared to those receiving SAVR, suggesting that while TAVR can be a viable option, careful patient selection is crucial due to the potential for complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter and Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valve Stenosis. Sanaiha, Y., Hadaya, JE., Tran, Z., et al.[2023]

In a meta-analysis of 54,047 patients with severe bicuspid aortic valve stenosis, transcatheter aortic valve replacement (TAVR) showed no significant differences in in-hospital mortality or stroke compared to surgical aortic valve replacement (SAVR).

TAVR was associated with a higher risk of permanent pacemaker implantation but lower risks of acute kidney injury and blood transfusion, suggesting it may offer certain safety advantages despite the increased pacemaker requirement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter versus surgical aortic valve replacement for stenotic bicuspid aortic valve: Systematic review and meta-analysis. Sakurai, Y., Yokoyama, Y., Kuno, T., et al.[2023]

In patients with bicuspid aortic stenosis (BAS), transcatheter aortic valve replacement (TAVR) shows comparable short-term outcomes to surgical aortic valve replacement (SAVR), with higher rates of permanent pacemaker implantation (PPI) but lower rates of bleeding events.

Type 1 BAS morphology in TAVR patients is linked to lower post-procedural transvalvular gradients and a higher incidence of conduction abnormalities, indicating that valve morphology can influence outcomes after TAVR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Meta-Analysis of Short-Term Outcomes of TAVR versus SAVR in Bicuspid Aortic Valve Stenosis and TAVR Results in Different Bicuspid Valve Anatomies. Improta, R., Di Pietro, G., Kola, N., et al.[2023]

In a study of 65,687 patients undergoing isolated surgical aortic valve replacement (SAVR), those with bicuspid aortic valves had significantly lower 5-year mortality rates compared to those with tricuspid valves, particularly among low-risk patients.

Both groups had similar 30-day mortality and major morbidity rates, but bicuspid patients also experienced lower rates of readmission for heart failure, stroke, and other cardiovascular issues over the 5-year period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benchmarking Outcomes of Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valves. Hirji, SA., Wegermann, Z., Vemulapalli, S., et al.[2023]

In a study of 187 patients with severe aortic stenosis, transcatheter aortic valve implantation (TAVI) showed similar 30-day mortality and morbidity rates compared to surgical aortic valve replacement (S-AVR), but resulted in shorter ICU stays and better immediate postoperative outcomes.

While TAVI patients had higher all-cause and noncardiac mortality rates over time due to their age and comorbidities, the overall morbidity and mortality associated with TAVI were lower than those expected from conventional surgery in high-risk patients, making it a viable option for those who are good surgical candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter vs. surgical aortic valve replacement: a retrospective analysis assessing clinical effectiveness and safety. Fusari, M., Bona, V., Muratori, M., et al.[2022]

Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) shows a comparable 30-day mortality rate to those with trileaflet aortic valves (TAV), indicating that TAVR can be a safe option for BAV patients.

However, patients with BAV experience a higher incidence of moderate to severe paravalvular leak (8.8% vs. 4.2% in TAV patients), suggesting that while TAVR is safe, it may be less effective in achieving optimal device success compared to TAV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of transcatheter aortic valve replacement in bicuspid aortic valve stenosis. Bob-Manuel, T., Heckle, MR., Ifedili, IA., et al.[2022]

In a study of 31,895 hospitalizations for patients with bicuspid aortic stenosis, transcatheter aortic valve replacement (TAVR) showed similar in-hospital mortality rates compared to surgical aortic valve replacement (SAVR), indicating that TAVR is a safe alternative for this population.

TAVR was associated with fewer complications such as acute myocardial infarction and post-operative bleeding, as well as a shorter hospital stay, although it did have a higher incidence of complete heart block requiring pacemaker insertion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal Trends and Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis. Elbadawi, A., Saad, M., Elgendy, IY., et al.[2020]

Transcatheter aortic valve replacement (TAVR) is increasingly being used for patients with bicuspid aortic valve (BAV) stenosis, showing a growth in procedure rates from 0.39% in 2011 to 4.16% in 2014, indicating a shift in treatment options for this population.

In-hospital outcomes for TAVR in BAV patients show no significant difference in mortality compared to surgical aortic valve replacement (SAVR), while the median length of hospital stay decreased significantly, suggesting TAVR may offer similar safety with improved recovery times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve replacement in patients with bicuspid aortic valve stenosis: national trends and in-hospital outcomes. Soud, M., Al-Khadra, Y., Darmoch, F., et al.[2022]

In a study of 33 high-risk patients undergoing transcatheter aortic valve implantation, the procedure was feasible in 30 cases, demonstrating a significant reduction in aortic gradient from 43.58 mmHg to 10.54 mmHg, indicating improved blood flow.

The procedure had an overall 30-day mortality rate of 18.18%, with only one operative death, suggesting that while the procedure is generally safe, careful monitoring and long-term follow-up are necessary to assess outcomes and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve implantation: results of the current development and implantation of a new Brazilian prosthesis. Gaia, DF., Palma, JH., Ferreira, CB., et al.[2022]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.119.040333

Outcomes of Transcatheter Aortic Valve Replacement in ... With current-generation devices, device success was slightly lower in the bicuspid (versus tricuspid) AV group (96.3% in bicuspid versus 97.4% ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6462665/

Outcomes of transcatheter aortic valve replacement in ... One-year mortality rate in the BAV population was 13.1% compared to 15.4% in the TAV patients (P=0.75). Patients with BAV had significantly more moderate to ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1936879824007994

3-Year Outcomes From the Evolut Low Risk TAVR Bicuspid ... Bicuspid TAVR had low rates of aortic valve–related hospitalization (5.4%; 95% CI: 2.3%-12.6% at 3 years), aortic valve reintervention (1.4%; 95 ...

4. jacc.org jacc.org/doi/10.1016/j.jacc.2025.03.004

5-Year Outcomes After Transcatheter or Surgical Aortic ... Cardiovascular mortality was 7.2% in the TAVR group and 9.3% in the surgery group (P = 0.15). Noncardiovascular mortality in the TAVR group was 6.8% and 6.2% in ...

5. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2771461

Transcatheter Aortic Valve Replacement in Low-risk ... Transcatheter aortic valve replacement in low–surgical risk patients with bicuspid aortic valve stenosis achieved favorable 30-day results, with low rates of ...

6. jacc.org jacc.org/doi/10.1016/j.jcin.2021.07.052

Outcomes After Transcatheter Aortic Valve Replacement in ... Device success and 1-year survival rates were similar between subjects with BAV and those with TAV (97% vs 94% [P = 0.55] and 91.3% vs 90.8% [P ...