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Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation (BASILICA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03381989
Recruitment Status : Active, not recruiting
First Posted : December 22, 2017
Results First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Native and Valve in Valve Aortic Valve Failure
Intervention Device: ASHI_INTECC Astato XS 20 0.014 guidewire
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Arm: Open-label Treatment
Hide Arm/Group Description The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.
Period Title: Overall Study
Started 30
Completed 22
Not Completed 8
Arm/Group Title Single Arm: Open-label Treatment
Hide Arm/Group Description The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  16.7%
>=65 years
25
  83.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
24
  80.0%
Male
6
  20.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Hispanic or Latino
1
   3.3%
Not Hispanic or Latino
29
  96.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   6.7%
White
28
  93.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Procedure Success, Measured at Exit From the Catheterization Laboratory
Hide Description Successful BASILICA traversal and laceration; immediate survival; successful first TAVR device implantation; absence of coronary artery obstruction; and freedom from emergency cardiac surgery or reintervention related to the BASILICA or TAVR procedure.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who underwent the BASILICA procedure
Arm/Group Title Single Arm: Open-label Treatment
Hide Arm/Group Description:
The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
28
2.Primary Outcome
Title Safety Endpoint is Freedom From Major Adverse Clinical Events (MACE)
Hide Description Freedom from major adverse clinical events (MACE) according to Valve Academic Research Consortium (VARC-2) at 30days.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who underwent the BASILICA procedure
Arm/Group Title Single Arm: Open-label Treatment
Hide Arm/Group Description:
The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.Laceration of the aortic valve leaflet using electrosurgery energy.
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
21
  70.0%
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm: Open-label Treatment
Hide Arm/Group Description The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.
All-Cause Mortality
Single Arm: Open-label Treatment
Affected / at Risk (%)
Total   1/30 (3.33%) 
Hide Serious Adverse Events
Single Arm: Open-label Treatment
Affected / at Risk (%)
Total   13/30 (43.33%) 
Cardiac disorders   
Cardiac pacemaker insertion   2/30 (6.67%) 
Hemodynamic instability from lacertation requiring vasopressors   2/30 (6.67%) 
Secondary myocardial infarction   1/30 (3.33%) 
Injury, poisoning and procedural complications   
Life threatening bleeding  [1]  2/30 (6.67%) 
Major vascular complication  [1]  6/30 (20.00%) 
Nervous system disorders   
Ischemic stroke  [2]  3/30 (10.00%) 
Renal and urinary disorders   
AKI - Acute Kidney Injury Stage 2/3   1/30 (3.33%) 
Indicates events were collected by systematic assessment
[1]
not related to BASILICA
[2]
Disabling 1 subject Non-disabling 2 subjects
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm: Open-label Treatment
Affected / at Risk (%)
Total   0/30 (0.00%) 
31 participants enrolled on protocol. 30 started the protocol, after 1 participant withdrew consent prior to the procedure.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lederman, Robert
Organization: National Heart Lung and Blood Institute
Phone: +1 301 402 6769
EMail: lederman@nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT03381989    
Other Study ID Numbers: 999918018
18-H-N018
First Submitted: December 21, 2017
First Posted: December 22, 2017
Results First Submitted: March 10, 2020
Results First Posted: March 24, 2020
Last Update Posted: March 24, 2020