BASILICA Procedure for Aortic Valve Stenosis

Not currently recruiting at 12 trial locations

Overseen By Robert J Lederman, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Disqualifiers: Chronic kidney disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to make a heart procedure called TAVR safer by testing a new tool, the TELLTALE guidewire system. TAVR replaces a heart valve, but sometimes a tissue flap can block blood flow, posing a life-threatening risk. The trial will test whether the new tool can prevent this blockage. It seeks participants planning to undergo TAVR who are at high risk for this type of blockage. Participants will have the procedure with the new tool and attend follow-up visits to monitor recovery. As an unphased trial, this study allows patients to contribute to innovative research that could enhance TAVR safety.

Do I need to stop my current medications for the trial?

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

Will I have to stop taking my current medications?

The trial protocol 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.

What prior data suggests that the TELLTALE device is safe for use during TAVR?

Research has shown that the BASILICA procedure, which prevents heart blood supply blockage during valve replacement, is generally safe. One study found the procedure successful in over 95% of cases, with patients avoiding serious complications.

Similarly, studies have indicated that the TELLTALE Electrosurgical Guidewire System is safe. This system, used to modify heart valve leaflets during replacement, has proven both safe and effective.

These findings suggest that both the BASILICA procedure and the TELLTALE system are well-tolerated by patients, with high success and safety rates. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BASILICA procedure for aortic valve stenosis because it offers a novel approach to addressing valve failure. Unlike traditional treatments like surgical aortic valve replacement or standard transcatheter aortic valve replacement (TAVR), the BASILICA procedure uses the TELLTALE Electrosurgical Guidewire System to split the native or failing bioprosthetic aortic valve leaflets. This innovative technique aims to prevent coronary artery obstruction during valve replacement, a serious complication sometimes associated with TAVR. By enhancing safety and potentially improving outcomes, the BASILICA procedure could become a valuable option for patients with this challenging condition.

What evidence suggests that the TELLTALE device is effective for preventing coronary artery obstruction during TAVR?

Studies have shown that the BASILICA procedure, which involves cutting a part of a heart valve, effectively prevents blockages in the coronary artery during TAVR (a type of heart valve replacement). One study found this technique successful in 97.7% of high-risk patients. In this trial, participants will undergo the BASILICA procedure using the TELLTALE Electrosurgical Guidewire System, which has proven safe and effective for adjusting heart valve leaflets. Thirty days after using this system, 95.3% of patients experienced no coronary artery blockage, and the risk of serious complications like death or stroke was very low. This evidence suggests that the BASILICA procedure with the TELLTALE system can greatly improve safety during heart valve replacement. ^{1 2 3 4 6}

Who Is on the Research Team?

Robert J Lederman, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

This trial is for adults aged 21 or older who need a heart valve replacement (TAVR) and are at high risk of coronary artery blockage during the procedure. Candidates must be considered likely to suffer from this complication based on CT analysis, agree to participate in all study procedures, and not expected to have other major health issues within the next year.

Inclusion Criteria

I understand the study's requirements and agree to follow them.

I am 21 years old or older.

My heart team considers surgery for my aortic valve too risky.

Exclusion Criteria

The heart valve is not working properly at the beginning of the study.

Needs a specific type of treatment called doppio (two-leaflet) BASILICA.

I am scheduled for a stent placement in my heart's artery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-procedure Assessment

Participants complete a questionnaire about their quality of life and undergo assessments of physical abilities and stroke risk

1 day

1 visit (in-person)

Treatment

Participants undergo TAVR with the TELLTALE guidewire system under general anesthesia or moderate sedation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including repeat assessments of physical abilities and quality of life

30 days

1 visit (in-person or remote)

Final Study Visit

Participants have a final study visit to assess long-term outcomes

90 days

1 visit (in-person or remote)

What Are the Treatments Tested in This Trial?

Interventions

• TELLTALE BASILICA procedure
• TELLTALE Electrosurgical Guidewire System

Trial Overview The TELLTALE BASILICA procedure is being tested. It's a new device designed specifically for cutting a leaflet in the heart that can block blood flow during TAVR. The goal is to make this life-saving valve replacement surgery safer by preventing coronary artery obstruction.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Patients undergoing TAVR with BASILICA using the Transmural TELLTALE guidewire system for bioprosthetic aortic valve failure or native aortic stenosis ( on label TAVR)

TELLTALE BASILICA procedure is already approved in United States for the following indications:

Approved in United States as BASILICA procedure for:

• Prevention of coronary artery obstruction during transcatheter aortic valve replacement (TAVR)

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The new Baha abutment covered by hydroxyapatite allows for a surgical technique that avoids soft tissue reduction, resulting in less bleeding and a lower risk of nerve damage, numbness, or pain post-operation.

In a study of 9 patients using this new technique, results showed similar implant stability and good cosmetic outcomes compared to 126 patients who underwent the standard technique, although there was a risk of soft tissue overhanging in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of results of using new Baha(®) abutment and new surgical technique without soft tissue reduction]. Gawęcki, W., Wróbel, M., Borucki, Ł., et al.[2022]

The BASILICA technique is designed to prevent coronary artery obstruction during transcatheter aortic valve replacement, utilizing both fluoroscopy and transesophageal echocardiography for guidance.

Based on over 50 procedures, this study outlines a detailed echocardiographic imaging protocol to enhance the safety and effectiveness of the BASILICA intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Echocardiographic Guidance of Intentional Leaflet Laceration prior to Transcatheter Aortic Valve Replacement: A Structured Approach to the Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction Procedure. Protsyk, V., Meineri, M., Kitamura, M., et al.[2021]

The BASILICA procedure, which involves intentionally lacerating aortic leaflets, has been successfully performed in over 1,000 high-risk patients to prevent coronary artery obstruction during transcatheter aortic valve replacement (TAVR), achieving a procedural success rate of 94.4%.

At 30 days post-procedure, 95.3% of patients were free from coronary artery obstruction, with low rates of all-cause mortality (2.8%) and disabling stroke (0.5%), indicating both the efficacy and safety of the BASILICA technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safeguards and pitfalls for Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction during transcatheter aortic valve replacement-the BASILICA technique. Bruce, CG., Greenbaum, AB., Babaliaros, VC., et al.[2021]

The 'Sheffield' incision technique for implantable temporal bone conduction systems resulted in higher patient satisfaction and more aesthetically pleasing outcomes compared to the inferiorly based flap technique, with no major complications like flap necrosis, which occurred in 25% of the flap cases.

The study, involving 32 patients over a 2-year period with an average follow-up of 6 months, showed that the 'Sheffield' technique had fewer minor complications (13% granulations) compared to the flap technique (55% granulations), indicating a safer and more effective surgical option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal access surgery for implantable bone conduction systems: early experience with the "Sheffield" incision. Ray, J., Addams-Williams, J., Baldwin, A.[2014]

The BASILICA technique, used before transcatheter aortic valve replacement (TAVR), was successful in preventing coronary artery obstruction in 93% of the 30 subjects studied, demonstrating its efficacy in high-risk patients.

Safety outcomes were generally acceptable, with 70% of subjects free from major adverse cardiovascular events, although there were some complications, including 20% experiencing major vascular issues related to TAVR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BASILICA Trial: Prospective Multicenter Investigation of Intentional Leaflet Laceration to Prevent TAVR Coronary Obstruction. Khan, JM., Greenbaum, AB., Babaliaros, VC., et al.[2023]

The study involved 14 patients with a total of 19 ears treated using a rib cartilage framework combined with local flap grafting, showing satisfactory and stable results over a follow-up period of four months to three years.

This innovative method effectively corrected the deformity of cryptotia, demonstrating long-term success and providing a valuable alternative to traditional surgical techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rib cartilage framework supporting combined with local flap grafting for correction of cryptotia]. Qian, J., Liu, T., Wang, BQ., et al.[2022]

A multicenter randomized controlled trial involving 62 participants is comparing the new Minimally Invasive Ponto Surgery (MIPS) technique to the traditional linear incision technique for bone conduction hearing implants, focusing on the incidence of peri-abutment dermatitis (PAD) over a 2-year follow-up period.

The study aims to evaluate not only the rate of PAD but also other important factors such as skin sensibility, wound healing, and cosmetic outcomes, using innovative sampling methods to better understand complications associated with the surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial. Calon, TG., van Hoof, M., van den Berge, H., et al.[2018]

A study involving 61 patients with congenital or acquired auricular defects demonstrated that using a porous high-density polyethylene (Medpor) framework for auricle reconstruction is a safe and effective method, with 80.3% of cases rated as excellent or good after a follow-up period averaging 2.8 years.

The two-stage surgical approach, which involved expanding postauricular skin before placing the Medpor framework, resulted in successful reconstructions, indicating that Medpor can be a reliable alternative when autogenous costal cartilage is not suitable for auricle reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical study on external ear reconstruction using expanded postauricular flap and medpor framework]. Song, C., Jiao, F., Zhuang, H.[2022]

Coronary artery obstruction is a rare but serious complication of transcatheter aortic valve replacement (TAVR), and the BASILICA technique is an innovative early-stage procedure designed to prevent this by intentionally lacerating aortic leaflets to maintain coronary artery inflow.

The review provides a comprehensive guide on predicting and preventing coronary artery obstruction during TAVR, including analyzing pre-procedural CT findings and detailed instructions for performing the BASILICA procedure, highlighting its potential as a valuable option in the absence of effective alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Coronary Obstruction During Transcatheter Aortic Valve Replacement: From Computed Tomography to BASILICA. Lederman, RJ., Babaliaros, VC., Rogers, T., et al.[2021]

The BASILICA procedure, which involves intentionally lacerating bioprosthetic or native aortic scallops, effectively prevents life-threatening coronary artery obstruction during transcatheter aortic valve replacement by maintaining blood flow to the coronary artery.

Successful execution of the BASILICA technique requires careful guidance and support from experienced operators, highlighting the importance of proctorship for achieving favorable clinical outcomes in initial procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction. Part 2: how to perform BASILICA. Komatsu, I., Mackensen, GB., Aldea, GS., et al.[2019]

The BASILICA technique demonstrated a high technical success rate of 97.7% in preventing coronary artery obstruction during transcatheter aortic valve implantation (TAVI) in 76 high-risk patients across ten European centers.

One-year outcomes were favorable, with an 84.2% survival rate and 90.5% of patients achieving functional improvement, indicating that BASILICA is a feasible and effective intervention for preventing complications associated with TAVI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procedural and one-year outcomes of the BASILICA technique in Europe: the multicentre EURO-BASILICA registry. Abdel-Wahab, M., Richter, I., Taramasso, M., et al.[2023]

The BASILICA procedure, designed to prevent coronary artery obstruction during transcatheter aortic valve replacement, demonstrated a high success rate of 86.9% in a study of 214 patients across 25 centers, with low rates of complications such as stroke (2.8%) and mortality (2.8%).

The study indicates that BASILICA is a safe and feasible intervention in real-world settings, achieving an overall one-year survival rate of 83.9% and effectively reducing the risk of coronary artery obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Coronary Obstruction During Transcatheter Aortic Valve Replacement: Results From the Multicenter International BASILICA Registry. Khan, JM., Babaliaros, VC., Greenbaum, AB., et al.[2022]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.120.010238

BASILICA Trial: One-Year Outcomes of Transcatheter ... BASILICA is a novel technique to prevent coronary artery obstruction. We report the 1-year outcomes of the BASILICA trial.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6669893/

The BASILICA Trial: Prospective Multicenter Investigation of ... BASILICA is a novel transcatheter technique performed immediately before TAVR to prevent coronary artery obstruction.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2474870622004596

Bioprosthetic or Native Aortic Scallop Intentional ... A novel technique that prevents coronary obstruction by slicing an aortic valve leaflet that puts the patient at risk for this complication.

4. eurointervention.pcronline.com eurointervention.pcronline.com/article/procedural-and-one-year-outcomes-of-the-basilica-technique-in-europe-the-multicentre-euro-basilica-registry

Procedural and one-year outcomes of the BASILICA ... This study evaluated the BASILICA technique in a multicenter European registry of 76 high-risk patients undergoing TAVI and found technical success of 97.7% ...

5. jacc.org jacc.org/doi/abs/10.1016/j.jcin.2019.03.035

The BASILICA Trial: Prospective Multicenter Investigation ... Primary success was met in 28 (93%) subjects. BASILICA traversal and laceration was successful in 35 of 37 (95%) attempted leaflets. There was 100% freedom from ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34003670/

BASILICA Trial: One-Year Outcomes of Transcatheter ... BASILICA is a novel technique to prevent coronary artery obstruction. We report the 1-year outcomes of the BASILICA trial.