Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli (TRAVERSE)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Neurocognitive Dysfunction

Treatments: Procedure: Retrograde Aortic Approach Catheter Ablation Procedure; Procedure: Transseptal Aortic Approach Catheter Ablation Procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT03946072

TRAVERSE

Details and patient eligibility

About

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).

Full 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.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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153 participants in 2 patient groups

Transseptal Group

Active Comparator group

Description:

Transseptal Aortic Approach Catheter Ablation Procedure

Treatment:

Procedure: Transseptal Aortic Approach Catheter Ablation Procedure

Retrograde Group

Active Comparator group

Description:

Retrograde Aortic Approach Catheter Ablation Procedure

Treatment:

Procedure: Retrograde Aortic Approach Catheter Ablation Procedure