NCT06269640Leállítva
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 18.
Megadott ok: Clinical trials terminated early due to trial feasibility
Rövid összefoglaló (regiszter, angolul)
Background: Some people have a condition in which the wall (septum) that separates the two main pumping chambers of the heart is too thick. This thick septum causes a condition called "left ventricular outflow tract obstruction" (LVOTO), which reduces blood flow out of the heart. LVOTO can cause serious heart disease; symptoms may include shortness of breath, chest pain, heart failure, or death. Researchers want to find better ways to treat LVOTO. Objective: To test a new procedure where excess tissue is sliced away from the septum in people with LVOTO. This procedure is called "septal scoring along midline endocardium" (SESAME). Eligibility: Adults aged 21 years with LVOTO. Design: Participants will have baseline tests. They will have imaging scans and tests of their heart structure and function. They will take a walking test and answer questions about how their heart condition affects their life. Participants will stay in the hospital 2 to 6 days for the SESAME procedure. They will be completely or partially asleep for the procedure. A tube will be inserted into the mouth and down the throat to take pictures of the heart. Pictures may also be taken with a tube inserted inside the heart. Next, tubes will be inserted into the groin and guided through the blood vessels up to the heart. Guidewires will be inserted into the heart. Doctors will watch the path the wires take with x-rays and ultrasound. When the wire is in the correct place, it will be electrified to slice excess tissue away from the septum. Participants will have 3 follow-up visits within 1 year.
- Állapot (regiszter)
- Leállítva
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 1 (tényleges)
- Első benyújtás
- 2024. febr. 17.
- Kezdés
- 2024. dec. 18.
- Elsődleges befejezés
- 2024. dec. 23.
- Fő szponzor
- National Heart, Lung, and Blood Institute (NHLBI)
- Betegségek
- Hipertrófiás kardiomiopátia
- NCT-szám
- NCT06269640
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Korábbi kezelés
- Prior completed transcoronary alcohol septal ablation, or prior surgical myectomy
Laborértékek
- eGFR < 30 mL/min/1.73m\^2
Egyéb
- Does not consent to participate, or unable to consent to participate
- Requires antegrade SESAME access (because of mechanical aortic valve)
- Pregnant
- Hemodynamic instability or emergency procedure
- Survival despite successful procedure expected < 12months
A regiszterben nem jelölt feltételek
- INCLUSION CRITERIA:
- Adults age >= 21 years
- Requires debulking of left ventricular septum for hypertrophic cardiomyopathy
- Septal diastolic thickness of obstructive hump on CT:
- Total >=16 mm, and
- Predicted residual septal thickness >= 8 mm, and
- 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; (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
Életkor a regiszterben: 21 év – 99 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Emory University Hospital | Atlanta | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.