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Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli

Key facts

Who runs it
University of California, San Francisco
Where
Aurora, Austin, Chicago, Cleveland, Denver, Houston, Los Angeles, Nashville, Palo Alto, Philadelphia, Phoenix, Portland, Salt Lake City, San Diego, San Francisco, St Louis, and Winston-Salem, United StatesSee the 20 sitesAlso in 1 other country, 1 site
Trial code
Status
Completed
People taking part
153 people enrolled
Started
2 Jul 2019
Ended
25 Nov 2023
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Transseptal Aortic Approach Catheter Ablation Procedure
  • Retrograde Aortic Approach Catheter Ablation Procedure
Record updated
26 December 2023

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Inability to perform neurocognitive function testing after > 24 hours free of sedating medications
  • 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
  • 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)

Where in United States

Also in 1 other country, 1 site

  • Kaiser Permanente ColoradoAurora, United StatesNo longer taking part
  • Texas Cardiac Arrhythmia Research FoundationAustin, United StatesNo longer taking part
  • University of ChicagoChicago, United StatesNo longer taking part
  • Cleveland ClinicCleveland, United StatesNo longer taking part
  • University of Colorado DenverDenver, United StatesNo longer taking part
  • Baylor College of MedicineHouston, United StatesNo longer taking part
  • Houston Methodist Research InstituteHouston, United StatesNo longer taking part
  • Cedars-Sinai Medical CenterLos Angeles, United StatesNo longer taking part
  • University of California, Los AngelesLos Angeles, United StatesNo longer taking part
  • Vanderbilt UniversityNashville, United StatesNo longer taking part
  • Stanford UniversityPalo Alto, United StatesNo longer taking part
  • University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
  • Banner University Medical CenterPhoenix, United StatesNo longer taking part
  • Oregon Health and Science UniversityPortland, United StatesNo longer taking part
  • University of UtahSalt Lake City, United StatesNo longer taking part
  • University of California San DiegoSan Diego, United StatesNo longer taking part
  • San Francisco Veterans Affairs (SFVA) Health CareSan Francisco, United StatesNo longer taking part
  • University of California San FranciscoSan Francisco, United StatesNo longer taking part
  • Washington University in St. LouisSt Louis, United StatesNo longer taking part
  • Atrium Health/Wake Forest UniversityWinston-Salem, United StatesNo longer taking part

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Transseptal GroupExisting treatment, for comparison

    Transseptal Aortic Approach Catheter Ablation Procedure

    Treatment: Transseptal Aortic Approach Catheter Ablation Procedure

  • Retrograde GroupExisting treatment, for comparison

    Retrograde Aortic Approach Catheter Ablation Procedure

    Treatment: Retrograde Aortic Approach Catheter Ablation Procedure

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Record updated
26 December 2023