Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Multi-center Comparative Effectiveness Randomized Trial to Assess a Transseptal Approach to Left Ventricular Ablation Compared to Retrograde to Prevent Cerebral Emboli & Neurocognitive Decline in Adults With Ventricular Tachycardia/Premature Ventricular Contractions

Conditions
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Neurocognitive Dysfunction

Intervention / Treatment
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* Procedure: Transseptal Aortic Approach Catheter Ablation Procedure
* Procedure: Retrograde Aortic Approach Catheter Ablation Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women ≥ 18 years of age Planned/scheduled endocardial ventricular tachycardia (VT) or premature ventricular contraction (PVC) catheter ablation procedure For this patient, the current plan of the operator must be to pursue a catheter ablation target in the left ventricular endocardium that can be accessed by either a transseptal puncture or retrograde aortic approach Life expectancy of at least 1 year Willing and able to undergo pre- and post-ablation MRIs Willing and able to return and comply with scheduled follow up visits (through the 6 month follow-up) Willing and able to provide written informed consent Exclusion Criteria: Planned epicardial ablation that would include a coronary angiogram (during the index ventricular tachycardia (VT) or premature ventricular contraction (PVC) catheter ablation procedure) Any contraindication to MRI (as defined by the institution performing the MRI) Clinical contraindication to a retrograde aortic approach as determined by the treating physician, including: Severe aortic stenosis Mechanical aortic valve Clinical contraindication to a transseptal puncture as determined by the treating physician, including: Severe Mitral valve stenosis Mechanical Mitral valve Atrial septal defect (ASD) or Patent foramen ovale (PFO) closure device that would preclude a transseptal puncture Mitraclip or Alfieri mitral valve repair that would preclude a transseptal puncture Planned or known need to perform either a retrograde aortic approach or transseptal approach (such as to target another site during the same procedure) Inability to speak, read, and write in the English language at a 6th grade level (required for the Neurocognitive Function Testing) Current mental impairment or other diagnosis which precludes accurate assessment of neurocognitive function or which may not allow patient to understand the nature, significance and scope of the study Inability to perform neurocognitive function testing after > 24 hours free of sedating medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transseptal Group<br>Transseptal Aortic Approach Catheter Ablation Procedure | Procedure: Transseptal Aortic Approach Catheter Ablation Procedure<br>* 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.<br>|
| Active Comparator: Retrograde Group<br>Retrograde Aortic Approach Catheter Ablation Procedure | Procedure: Retrograde Aortic Approach Catheter Ablation Procedure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | from baseline (pre-ablation) to 6 months post-ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | on day 1 post-ablation | 
| complications related to the ablation procedure, rate | rate of complications related to the ablation procedure | post-ablation, through Month 6 | 
| symptoms specific to VT/PVC, change | change in self-reported symptoms specific to VT/PVC | 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. | 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. | 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 | at 6 months post-ablation |