A Study of Two Different Ablation Methods (Transseptal vs Retrograde) to Reduce Systemic Emboli (blood clots)

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Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: ablation, cardiac ablation, heart rhythm, aorta, blood clots
Type: Procedure study
Target:
18 Participants
Investigator:
Description
The purpose of this study is to compare two different methods of performing an ablation. An ablation is a procedure to treat your abnormal heart rhythm by making small scars in your heart tissue. This prevents abnormal electric signals from moving through your heart.

In the United States, both methods in this study are used regularly. No one has studied whether one method is better than the other at preventing blood clots or other particles that can travel to the brain and cause blockages leading to possible loss of mental ability.

The difference between the two methods is the way that the doctor will approach your heart to treat your abnormal hearth rhythm. Your doctor has experience with both methods and uses both in the course of normal medical care. To perform your ablation procedure, the doctor needs to use a catheter (a long flexible thin tube). It will be used to enter the left ventricle, an area of your heart that will be treated.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

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:
  4. Severe Aortic stenosis
  5. Mechanical aortic valve
  6. Clinical contraindication to a transseptal puncture as determined by the treating physician , including:
  7. Severe Mitral valve stenosis
  8. Mechanical Mitral valve
  9. ASD or PFO closure device that would preclude a transseptal puncture
  10. Mitraclip or Alfieri mitral valve repair that would preclude a transseptal puncture
  11. Planned or known need to perform either a retrograde aortic approach or transseptal approach (such as to target another site during the same procedure)
  12. Inability to speak, read, and write in the English language at a 6th grade level (required for the Neurocognitive Function Testing)
  13. 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
  14. Inability to perform neurocognitive function testing after > 24 hours free of sedating medications
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study team will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for 6 months after the study procedure.
Recruitment period
From Jan. 22, 2020
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Neurocognitive Dysfunction

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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