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

July 7, 2016 updated by: Dhanunjaya Lakkireddy, MD, FACC
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People who are undergoing an intial AF ablation procedure.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dhanunjaya Lakkireddy, MD, FACC

Collaborators

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Estimate)

July 11, 2016

Last Update Submitted That Met QC Criteria

July 7, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003285

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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