Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli

Not Applicable

Completed

• Conditions: Neurocognitive Dysfunction
• Interventions: Procedure: Transseptal Aortic Approach Catheter Ablation Procedure; Procedure: Retrograde Aortic Approach Catheter Ablation Procedure

• Registration Number: NCT03946072
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-10
• Study Start: 2019-07-02
• Primary Completion: 2023-11-25
• Study Completion: 2023-11-25
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transseptal Group	Transseptal Aortic Approach Catheter Ablation Procedure	Transseptal Aortic Approach Catheter Ablation Procedure
Retrograde Group	Retrograde Aortic Approach Catheter Ablation Procedure	Retrograde Aortic Approach Catheter Ablation Procedure

Primary Outcome Measures

Name	Time	Method
overall neurocognitive function, change	from baseline (pre-ablation) to 6 months post-ablation	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.
cerebral embolic lesion incidence	on day 1 post-ablation	incidence of new cerebral embolic lesions measured by magnetic resonance imaging (MRI) post-ablation as compared to pre-ablation imaging studies

Secondary Outcome Measures

Name	Time	Method
quality of life composite score, change	from baseline (pre-ablation) to 6 months post-ablation	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.
complications related to the ablation procedure, rate	post-ablation, through Month 6	rate of complications related to the ablation procedure
symptoms specific to VT/PVC, change	from pre-ablation to post-ablation, through Month 6	change in self-reported symptoms specific to VT/PVC
physical activity (MET-min/week), change	from baseline (pre-ablation) to 6 months post-ablation	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.
new cerebral embolic lesions, number	on day 1 post-ablation	number of new cerebral embolic lesions per person, measured by magnetic resonance imaging (MRI) post-ablation as compared to pre-ablation imaging studies
recurrent arrhythmias, rate	at 6 months post-ablation	rate of recurrent arrhythmias determined as part of routine clinical care, measured using ECG and continuous ECG monitoring, if data is available

Trial Locations

Locations (21)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Houston Methodist Research Institute; 🇺🇸 Houston, Texas, United States

Banner - University Medical Center; 🇺🇸 Phoenix, Arizona, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

San Francisco Veterans Affairs (SFVA) Health Care; 🇺🇸 San Francisco, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Colorado, Denver; 🇺🇸 Denver, Colorado, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Kaiser Permanente - Colorado; 🇺🇸 Aurora, Colorado, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Atrium Health/Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Texas Cardiac Arrhythmia Research Foundation; 🇺🇸 Austin, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Hôpital du Sacré-Cœur de Montréal; 🇨🇦 Montréal, Quebec, Canada

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States