Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Ventricular arrhythmia is a condition that occurs when the lower chambers of the heart beat too fast. One of the most effective treatments for this health problem is a procedure called catheter ablation. During this procedure, a doctor inserts a thin tube called a catheter into the lower left chamber of the heart. The doctor uses the catheter to scar the tissue that is causing the heart to beat too fast, which fixes the problem. 

Doctors insert the catheter into the heart in one of two ways:

  • In the transseptal approach, the doctor inserts the catheter into the heart through veins, starting in the upper leg.
  • In the retrograde approach, the doctor inserts the catheter through a small artery in the upper leg. The catheter travels through the aorta to reach the heart.

Both procedures have a risk of brain damage. This damage may be caused by the catheter blocking blood flow to the brain; or the catheter may scrape off tissue that travels through the bloodstream to the brain.

In this study, the research team is comparing how the two approaches affect brain function.

Who can this research help?

Results may help doctors and patients considering approaches to catheter ablation for treating ventricular arrhythmia.

What is the research team doing?

The research team is enrolling 150 patients scheduled to have a catheter ablation to treat ventricular arrhythmia at 12 clinical sites across the United States. The team is assigning patients by chance to receive either the transseptal or retrograde approach. Before the procedure and one day afterward, patients receive an MRI to assess brain function and check for brain lesions. The team is following up with patients six months later to assess

  • Brain function
  • Complications from the procedure
  • Arrhythmia symptoms
  • Quality of life
  • Physical activity

Patients and doctors including cardiologists and neurologists are helping to plan and conduct this study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population 150 adults with a scheduled catheter ablation procedure for endocardial ventricular tachycardia (VT) or premature ventricular contractions (PVCs) 
Interventions/
Comparators
  • Transseptal approach to catheter ablation
  • Retrograde approach to catheter ablation  
Outcomes

Primary: incidence of cerebral embolic lesions, neurocognitive function

Secondary: new cerebral embolic lesions, complications related to ablation procedure, symptoms specific to VT/PVCs, quality of life, physical activity, recurrent arrhythmias 

Timeframe Up to 6-month follow-up for primary outcomes 

Project Information

Gregory Marcus, MD, MAS
The Regents of the University of California, San Francisco
$2,798,968
Transseptal versus Retrograde Aortic Approach to Left Ventricular Catheter Ablation

Key Dates

August 2018
November 2023
2018

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 15, 2022