Atrial Fibrillation
Conditions
Brief summary
The purpose of this study is to collect information about the success rate of atrial fibrillation (AF) ablation procedures using the contact force data from the TactiCath Quartz ablation catheter.
Detailed description
Atrial fibrillation is a condition in which the upper chambers of the heart (the atria) begin to quiver (shake rapidly with small movements) instead of beating in a normal rhythm. This condition can cause blood to remain in the atria instead of moving to the lower heart chambers. AF can cause a number of other health problems and can decrease your quality of life. Treatments for AF can include surgery, implantable devices, ablation and medication, to name a few. An ablation is a procedure that creates scar tissue in the heart to interrupt irregular heart rhythms and prevent them from coming back. The ablation procedure uses tools called catheters to treat the AF. Ablation catheters are thin, flexible plastic tubes that use electrical energy to create scars in the heart. The amount of force applied to the heart tissue where the catheter touches (called the contact force) might help determine the success of the ablation procedure. This study would help to determine whether or not the contact force makes a difference in an effective ablation. You will be tested on both sides, at the end of the procedure to see if any problem persists. Participants will be in this study for about 3 months. All visits in this study will correspond to standard of care visits.
Interventions
PROCEDUREAF Ablation with contact force information
Ablation procedure will be done using TactiCath Quartz ablation catheter which can measure the amount of contact force being used. Researcher will be made aware of contact force data when performing procedure.
PROCEDUREAF Ablation without contact force information
Ablation procedure will be done using TactiCath Quartz ablation catheter which can measure the amount of contact force being used. Researcher will not be made aware of contact force data when performing procedure.
Sponsors
Abbott Medical Devices
Dhanunjaya Lakkireddy, MD, FACC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing an initial AF ablation procedure * Able to sign informed consent and complete the 3 month follow up
Exclusion criteria
* Severe COPD and is unable to receive adenosine therapy during the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of dormant conduction | intraoperative | Comparison of rates between pulmonary veins where the contact force information was known to researcher during ablation procedure versus contact force information NOT known during procedure |
Countries
United States
Outcome results
None listed