Vanderbilt Clinical Trials

Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli

Purpose

Condition

Neurocognitive Dysfunction

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

Men and women ≥ 18 years of age 2. Planned/scheduled endocardial ventricular tachycardia (VT) or premature ventricular contraction (PVC) catheter ablation procedure 3. 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 4. Life expectancy of at least 1 year 5. Willing and able to undergo pre- and post-ablation MRIs 6. Willing and able to return and comply with scheduled follow up visits (through the 6 month follow-up) 7. 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) 2. Any contraindication to MRI (as defined by the institution performing the MRI) 3. Clinical contraindication to a retrograde aortic approach as determined by the treating physician, including: 1. Severe aortic stenosis 2. Mechanical aortic valve 4. Clinical contraindication to a transseptal puncture as determined by the treating physician, including: 1. Severe Mitral valve stenosis 2. Mechanical Mitral valve 3. Atrial septal defect (ASD) or Patent foramen ovale (PFO) closure device that would preclude a transseptal puncture 4. Mitraclip or Alfieri mitral valve repair that would preclude a transseptal puncture 5. Planned or known need to perform either a retrograde aortic approach or transseptal approach (such as to target another site during the same procedure) 6. Inability to speak, read, and write in the English language at a 6th grade level (required for the Neurocognitive Function Testing) 7. 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 8. Inability to perform neurocognitive function testing after > 24 hours free of sedating medications

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Masking: Single (Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Transseptal Group	Transseptal Aortic Approach Catheter Ablation Procedure	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.
Active Comparator Retrograde Group	Retrograde Aortic Approach Catheter Ablation Procedure	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.

More Details

Status: Completed
Sponsor: University of California, San Francisco

Study Contact

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.