This study is a prospective, multicenter, randomized (1:1) controlled comparative effectiveness trial of a transseptal approach to left ventricular ablation compared to a retrograde aortic approach to prevent cerebral emboli and neurocognitive decline in adults with ventricular tachycardia (VT) and/or premature ventricular contractions (PVCs).
This study is a prospective, multicenter, randomized (1:1) controlled comparative effectiveness trial of a transseptal approach to left ventricular ablation compared to a retrograde aortic approach to prevent cerebral emboli and neurocognitive decline in adults with ventricular tachycardia (VT) and/or premature ventricular contractions (PVCs). Participants will be followed for 6 months post-study procedure. This study will be conducted at up to 12 clinical sites in the United States. A total of one-hundred and fifty (150) participants will be enrolled and randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
153
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.
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.
Banner - University Medical Center
Phoenix, Arizona, United States
cerebral embolic lesion incidence
incidence of new cerebral embolic lesions measured by magnetic resonance imaging (MRI) post-ablation as compared to pre-ablation imaging studies
Time frame: on day 1 post-ablation
overall neurocognitive function, change
percent change in overall neurocognitive function score from baseline (pre-ablation). The neurocognitive function examination includes items from the Brain Health Assessment, a validated, multi-domain testing battery aims to detect cognitive impairment in older adults. The TRAVERSE Testing Battery will include the following tests: Favorites (Forms A and B), Match (Forms A and B), Favorites Delay (Forms A and B), Favorites Recognition (Forms A and B), Dot Counting (Forms A and B), Flanker, and Running Dots.
Time frame: from baseline (pre-ablation) to 6 months post-ablation
new cerebral embolic lesions, number
number of new cerebral embolic lesions per person, measured by magnetic resonance imaging (MRI) post-ablation as compared to pre-ablation imaging studies
Time frame: on day 1 post-ablation
complications related to the ablation procedure, rate
rate of complications related to the ablation procedure
Time frame: post-ablation, through Month 6
symptoms specific to VT/PVC, change
change in self-reported symptoms specific to VT/PVC
Time frame: from pre-ablation to post-ablation, through Month 6
quality of life composite score, change
change in quality of life score (composite summary points) measured using the Short Form 12-item Survey (SF-12), a validated measure of health status.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cedars Sinai Medical Center
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California, San Diego
San Diego, California, United States
San Francisco Veterans Affairs (SFVA) Health Care
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Kaiser Permanente - Colorado
Aurora, Colorado, United States
University of Colorado, Denver
Denver, Colorado, United States
University of Chicago
Chicago, Illinois, United States
...and 11 more locations
Time frame: from baseline (pre-ablation) to 6 months post-ablation
physical activity (MET-min/week), change
change in total physical activity (MET-min/week) measured using the International Physical Activity Questionnaire (IPAQ) short format questionnaire, validated for physical activity-related energy expenditure.
Time frame: from baseline (pre-ablation) to 6 months post-ablation
recurrent arrhythmias, rate
rate of recurrent arrhythmias determined as part of routine clinical care, measured using ECG and continuous ECG monitoring, if data is available
Time frame: at 6 months post-ablation