Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli

NACompletedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

July 2, 2019

Primary Completion Date

November 25, 2023

Study Completion Date

November 25, 2023

Conditions
Neurocognitive Dysfunction
Interventions
PROCEDURE

Transseptal Aortic Approach Catheter Ablation Procedure

The transseptal approach entails obtaining femoral venous access, and, guided by fluoroscopy and intra-cardiac ultrasound, starting with a transseptal needle or radio frequency (RF) device inside the dilator of a long sheath; pulling down until the fossa ovalis in the interatrial septum is engaged on both fluoroscopy and intracardiac echo imaging; once on the left side, the long sheath is advanced over the transseptal needle, the needle and dilator are removed, and the ablation catheter can then be advanced across the mitral valve into the left ventricle.

PROCEDURE

Retrograde Aortic Approach Catheter Ablation Procedure

The retrograde aortic approach entails obtaining femoral arterial access and leaving a sheath in the femoral artery. Under fluoroscopy, an ablation catheter is then advanced up the ascending aorta where the catheter tip is curved using an internal mechanism controlled on the handle of the catheter to form a large loop (to prevent the tip from traveling down a coronary artery and causing trauma such as a dissection); the curved loop is advanced around the aortic arch and down the ascending aorta. To cross the aortic valve with this loop, the catheter is typically torqued in various directions until it falls through the aortic valve and into the left ventricle.

Trial Locations (21)

19104

University of Pennsylvania, Philadelphia

27157

Atrium Health/Wake Forest University, Winston-Salem

37235

Vanderbilt University, Nashville

44195

Cleveland Clinic, Cleveland

60637

University of Chicago, Chicago

63110

Washington University in St. Louis, St Louis

77030

Baylor College of Medicine, Houston

Houston Methodist Research Institute, Houston

78705

Texas Cardiac Arrhythmia Research Foundation, Austin

80014

Kaiser Permanente - Colorado, Aurora

80204

University of Colorado, Denver, Denver

84112

University of Utah, Salt Lake City

85006

Banner - University Medical Center, Phoenix

90048

Cedars Sinai Medical Center, Los Angeles

90095

University of California, Los Angeles, Los Angeles

92093

University of California, San Diego, San Diego

94121

San Francisco Veterans Affairs (SFVA) Health Care, San Francisco

94143

University of California, San Francisco, San Francisco

94305

Stanford University, Palo Alto

97239

Oregon Health and Science University, Portland

Unknown

Hôpital du Sacré-Cœur de Montréal, Montreal

All Listed Sponsors
lead

University of California, San Francisco

OTHER

NCT03946072 - Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli | Biotech Hunter | Biotech Hunter