Use of a Novel Contact Force Sensing Catheter for AF Ablation - Impact of TactiCath on Dormant Conduction Across the Pulmonary Veins

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Procedure: AF Ablation with contact force information; Procedure: AF Ablation without contact force information

• Registration Number: NCT02666729
• Lead Sponsor: Dhanunjaya Lakkireddy, MD, FACC

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.

Study Timeline

• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-01-28
• Status Verified: 2016-07
• Study Start: 2016-07
• Last Update Submitted: 2016-07-07
• Last Update Posted: 2016-07-11
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AF Ablation Procedure	AF Ablation with contact force information	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.
AF Ablation Procedure	AF Ablation without contact force information	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States