BASILICA Procedure for Aortic Valve Stenosis

Recruiting at 10 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

139 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called TELLTALE, designed to make heart valve replacement surgery safer. It targets patients over 21 who are at high risk of blocked blood flow to the heart. The device cuts a tissue flap that can cause this blockage, aiming to reduce complications and improve patient outcomes. This type of heart valve replacement has emerged as an effective treatment option in patients with severe aortic stenosis, supported by a series of studies.

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 data supports the idea that BASILICA Procedure for Aortic Valve Stenosis is an effective treatment?

The available research does not provide any data on the effectiveness of the BASILICA Procedure for Aortic Valve Stenosis. The studies listed focus on different medical procedures and conditions, such as hearing implants and ear reconstruction, rather than the BASILICA procedure or aortic valve stenosis. ^{1 2 3 4 5}

What safety data is available for the BASILICA procedure for aortic valve stenosis?

The BASILICA procedure has been studied in various trials and registries, including the prospective BASILICA IDE Trial and the International BASILICA Registry. Data from these studies indicate that the procedure is generally safe and effective. The International BASILICA Registry, which included 214 patients, reported a procedural success rate of 94.4%. At thirty days post-procedure, 95.3% of patients were free from coronary artery obstruction, with an all-cause mortality rate of 2.8% and a disabling stroke rate of 0.5%. These findings support the safety and efficacy of the BASILICA procedure in preventing coronary artery obstruction during transcatheter aortic valve replacement. ^{6 7 8 9 10}

Is the BASILICA procedure generally safe for humans?

The BASILICA procedure has been performed in over 1,000 patients and is considered generally safe, with a high procedural success rate of 94.4%. At thirty days after the procedure, 95.3% of patients were free from coronary artery obstruction, with a low all-cause mortality rate of 2.8% and a very low rate of disabling stroke at 0.5%. ^{6 7 8 9 10}

Is the BASILICA procedure a promising treatment for aortic valve stenosis?

Yes, the BASILICA procedure is a promising treatment for aortic valve stenosis. It helps prevent a serious complication called coronary artery obstruction during valve replacement surgery. The procedure has been successful in over 94% of cases, with most patients avoiding coronary obstruction and having low rates of serious complications like stroke or death. ^{6 7 9 11 12}

How does the BASILICA procedure for aortic valve stenosis differ from other treatments?

The BASILICA procedure is unique because it uses a transcatheter electrosurgical technique to intentionally split the aortic valve leaflets, preventing coronary artery blockage during valve replacement. This approach is different from other methods like 'snorkel' stenting, which can have serious complications, making BASILICA a promising option despite being relatively new. ^{6 7 9 11 12}

Research Team

Robert J Lederman, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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 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 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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Clinical study on external ear reconstruction using expanded postauricular flap and medpor framework]. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Rib cartilage framework supporting combined with local flap grafting for correction of cryptotia]. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Minimal access surgery for implantable bone conduction systems: early experience with the "Sheffield" incision. [2014]

4. England 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. [2018]

5. Poland pubmed.ncbi.nlm.nih.gov

[Evaluation of results of using new Baha(®) abutment and new surgical technique without soft tissue reduction]. [2022]

6. United States 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. [2021]

7. France pubmed.ncbi.nlm.nih.gov

Procedural and one-year outcomes of the BASILICA technique in Europe: the multicentre EURO-BASILICA registry. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The BASILICA Trial: Prospective Multicenter Investigation of Intentional Leaflet Laceration to Prevent TAVR Coronary Obstruction. [2023]

9. China 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Preventing Coronary Obstruction During Transcatheter Aortic Valve Replacement: Results From the Multicenter International BASILICA Registry. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Preventing Coronary Obstruction During Transcatheter Aortic Valve Replacement: From Computed Tomography to BASILICA. [2021]

12. France pubmed.ncbi.nlm.nih.gov

Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction. Part 2: how to perform BASILICA. [2019]