Use of a Novel Contact Force Sensing Catheter for AF Ablation - Impact of TactiCath on Dormant Conduction Across the Pulmonary Veins (FORMIDIBLE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02666729|
Recruitment Status : Withdrawn
First Posted : January 28, 2016
Last Update Posted : July 11, 2016
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Procedure: AF Ablation with contact force information Procedure: AF Ablation without contact force information|
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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Use of a Novel Contact Force Sensing Catheter for AF Ablation - Impact of TactiCath on Dormant Conduction Across the Pulmonary Veins|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
AF Ablation Procedure
Patients with AF who are schedule for a first time pulmonary vein isolation (PVI) for AF using the TactiCath catheter. Patients will have four pulmonary veins ablated during procedure. The researcher will perform AF Ablation with contact force information on two veins. The research will perform AF Ablation without contact force information on the other two veins.
Procedure: AF 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.
Procedure: AF 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.
- Rates of dormant conduction [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666729
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Dhanunjaya Lakkireddy, MD||University of Kansas Medical Center|