← Back to Search

Procedure

SESAME Arm for Aortic Valve Stenosis

N/A

Waitlist Available

Led By Robert J Lederman, M.D.

Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria Checklist

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

Must have

Requires debulking of left ventricular septum for one of three phenotypes: 1) Hypertrophic cardiomyopathy; 2) Left ventricular septal hypertrophy, mitral valve disease and/or aortic valve stenosis warranting/following transcatheter heart valve implantation, WITH intracameral gradient >= (30mmHg peak while resting; 50mmHg peak when provoked); 3) Left ventricular septal hypertrophy, mitral valve disease warranting transcatheter heart valve implantation, and risk of iatrogenic left ventricular outflow tract obstruction (LVOTO), Neo-LVOT <= 200 mm^2, WITHOUT intracameral gradient >= (30mmHg peak while resting; 50mmHg peak when provoked); Septal diastolic thickness on CT: Total >=12 mm, Predicted residual septal thickness >= 6 mm, Predicted laceration depth >= 6 mm; Severely symptomatic, any of: NYHA Class III or greater, Canadian Angina Class CCS III or greater, Explicitly chooses investigational SESAME over conventional treatment approaches including (1) cardiac myosin inhibitor therapy, if eligible (HCM only); (2) transcoronary alcohol septal ablation, if eligible; or (3) surgical left ventricular myotomy and/or myectomy, if eligible; Concurrence of the multidisciplinary institutional heart team that the candidate is at high risk for surgical myectomy, Concurrence of the study Central Clinical Eligibility Committee, Willing to return for all scheduled follow-up activities, and eligible or able to undergo required protocol and testing; Additional selection criteria for Hypertrophic Cardiomyopathy: High risk of surgical myotomy/myectomy according to the multidisciplinary heart team

Adults age >= 21 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up discharge

Awards & highlights

Study Summary

"This trial is testing a new procedure called SESAME in adults with a condition where the heart's pumping chambers are separated by a thick wall. This thick wall can cause reduced blood flow and serious heart disease

Who is the study for?

This trial is for adults aged 21 years and older with a heart condition where the wall between their heart's pumping chambers is too thick, causing reduced blood flow. Participants must be able to stay in the hospital for up to 6 days and commit to follow-up visits within a year.Check my eligibility

What is being tested?

The study tests a new procedure called 'septal scoring along midline endocardium' (SESAME) designed to remove excess tissue from the septum of patients with left ventricular outflow tract obstruction, aiming to improve blood flow from the heart.See study design

What are the potential side effects?

Potential side effects may include complications related to anesthesia, risks associated with invasive procedures such as bleeding or infection at the insertion site, and possible damage to structures inside the heart.

Eligibility Criteria

Inclusion Criteria

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

Select...

I need a specific heart procedure due to severe symptoms or conditions.

Select...

I am 21 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Safety

Technical success

Secondary outcome measures

Complete heart block requiring permanent pacemaker

Trial Design

1Treatment groups

Experimental Treatment

Group I: SESAME ArmExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

3,834 Previous Clinical Trials

47,310,605 Total Patients Enrolled

11 Trials studying Aortic Valve Stenosis

1,885 Patients Enrolled for Aortic Valve Stenosis

Robert J Lederman, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)

12 Previous Clinical Trials

815 Total Patients Enrolled

3 Trials studying Aortic Valve Stenosis

184 Patients Enrolled for Aortic Valve Stenosis

Frequently Asked Questions

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

Are individuals still eligible to apply for participation in this ongoing trial?

"Based on the information from clinicaltrials.gov, it appears that recruitment for this specific trial is presently closed. The initial posting of the study was dated 2/26/2024, with the latest update made on 2/20/2024. Despite this trial no longer accepting applicants, there are a substantial number of 421 alternative trials actively seeking participants at present."

Answered by AI

Is there an inclusion of individuals aged 85 and older in this clinical study?

"Participants between 21 and 99 years old are sought for this research endeavor. It is noteworthy that there are a total of 51 trials catering to minors under the age of 18, while seniors aged over 65 have access to 389 clinical investigations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study

2024. "NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06269640.

All > Hypertrophic Cardiomyopathy