Trial Outcomes & Findings for NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study (NCT NCT06269640)

Last Updated: 2025-12-18

Results Overview

The primary feasibility endpoint is Technical success with the SESAME (SEptal Scoring Along Midline Endocardium) technique. All of the following must be present: * Alive * Procedure success including * Successful myocardial entry, navigation, and snaring of guidewire traversal system; and * Successful laceration of septal myocardium

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

1 minute following procedure discharge (Exit from the catheterization laboratory)

Results posted on

2025-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure that relies on intramyocardial guidewire navigation and transcatheter electrosurgery.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure that relies on intramyocardial guidewire navigation and transcatheter electrosurgery.
Overall Study Death	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure n=1 Participants Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure that relies on intramyocardial guidewire navigation and transcatheter electrosurgery.
Age, Categorical <=18 years	0 Participants n=47 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=47 Participants
Age, Categorical >=65 years	1 Participants n=47 Participants
Sex: Female, Male Female	1 Participants n=47 Participants
Sex: Female, Male Male	0 Participants n=47 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=47 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=47 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=47 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=47 Participants
Race (NIH/OMB) Asian	0 Participants n=47 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=47 Participants
Race (NIH/OMB) Black or African American	0 Participants n=47 Participants
Race (NIH/OMB) White	1 Participants n=47 Participants
Race (NIH/OMB) More than one race	0 Participants n=47 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=47 Participants
Region of Enrollment United States	1 participants n=47 Participants

PRIMARY outcome

Timeframe: 1 minute following procedure discharge (Exit from the catheterization laboratory)

Outcome measures

Outcome measures
Measure	Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure n=1 Participants Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure that relies on intramyocardial guidewire navigation and transcatheter electrosurgery.
Number of Participant That Experienced Technical Success With the SESAME (SEptal Scoring Along Midline Endocardium)	1 Participants

PRIMARY outcome

Timeframe: Up to 4 days

Number of Inpatient Safety Events related to SESAME (SEptal Scoring Along Midline Endocardium) Safety is measured as freedom from all of the following: * All-cause mortality * All stroke (disabling and non-disabling) * Major cardiac structural complication requiring intervention (such as iatrogenic ventricular septal defect, iatrogenic aortic valve regurgitation, iatrogenic mitral regurgitation, or pericardial tamponade).

Outcome measures

Outcome measures
Measure	Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure n=1 Participants Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure that relies on intramyocardial guidewire navigation and transcatheter electrosurgery.
Number of Inpatient Safety Events Related to SESAME (SEptal Scoring Along Midline Endocardium)	2 Number of Safety Events

SECONDARY outcome

Timeframe: Up to 4 Days

Number of Complete heart block events requiring permanent pacemaker included in cardiac arrest

Outcome measures

Outcome measures
Measure	Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure n=1 Participants Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure that relies on intramyocardial guidewire navigation and transcatheter electrosurgery.
Number of Complete Heart Block Events	1 Complete Heart Block Events

Adverse Events

Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure n=1 participants at risk Participants Undergoing SEptal Scoring Along Midline Endocardium (SESAME) Procedure that relies on intramyocardial guidewire navigation and transcatheter electrosurgery.
General disorders Multipressor Vasoplegic Shock	100.0% 1/1 • Number of events 1 • Up to 4 days
Cardiac disorders Ventricular Septal Defect	100.0% 1/1 • Number of events 1 • Up to 4 days
Cardiac disorders Cardiac Arrest	100.0% 1/1 • Number of events 1 • Up to 4 days
Renal and urinary disorders Acute Kidney Injury	100.0% 1/1 • Number of events 1 • Up to 4 days
Blood and lymphatic system disorders Anemia	100.0% 1/1 • Number of events 1 • Up to 4 days

Other adverse events

Adverse event data not reported

Additional Information

Robert Lederman, M.D.

National Heart Lung and Blood Institute

Phone: 301.402.6769

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators may not independently publish, present, or disclose study results, in whole or in part, without permission of the Publications Committee.
Publication restrictions are in place

Restriction type: OTHER