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

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ClinicalTrials.gov Identifier: NCT02666729
Recruitment Status : Withdrawn
First Posted : January 28, 2016
Last Update Posted : July 11, 2016
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Procedure: AF Ablation with contact force information Procedure: AF Ablation without contact force information

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.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People who are undergoing an intial AF ablation procedure.
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Dhanunjaya Lakkireddy, MD, FACC
Abbott Medical Devices
Investigators
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Principal Investigator: Dhanunjaya Lakkireddy, MD University of Kansas Medical Center

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Responsible Party: Dhanunjaya Lakkireddy, MD, FACC, Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02666729     History of Changes
Other Study ID Numbers: STUDY00003285
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes