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