Clinical trial NCT03946072: Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurocognitive Dysfunction
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. 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:

1. 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

Primary outcomes:
measure: cerebral embolic lesion incidence
timeFrame: on day 1 post-ablation
measure: overall neurocognitive function, change
timeFrame: from baseline (pre-ablation) to 6 months post-ablation
Secondary outcomes:
measure: new cerebral embolic lesions, number
timeFrame: on day 1 post-ablation
measure: complications related to the ablation procedure, rate
timeFrame: post-ablation, through Month 6
measure: symptoms specific to VT/PVC, change
timeFrame: from pre-ablation to post-ablation, through Month 6
measure: quality of life composite score, change
timeFrame: from baseline (pre-ablation) to 6 months post-ablation
measure: physical activity (MET-min/week), change
timeFrame: from baseline (pre-ablation) to 6 months post-ablation
measure: recurrent arrhythmias, rate
timeFrame: at 6 months post-ablation
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner - University Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs (SFVA) Health Care
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: Kaiser Permanente - Colorado
state: Colorado
city: Denver
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Winston-Salem
country: United States
facility: Atrium Health/Wake Forest University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Montréal
country: Canada
facility: Hôpital du Sacré-Cœur de Montréal
state: Quebec
Study officials:
affiliation: University of California, San Francisco
name: Gregory Marcus, MD
role: PRINCIPAL_INVESTIGATOR
References: