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

NCT02666729 | Withdrawn

• 1 other identifier: STUDY00003285
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Rates of dormant conduction

  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

Study Arms (1)

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; Procedure: AF Ablation without contact force information

Interventions

AF Ablation with contact force information PROCEDURE

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.

AF Ablation Procedure

AF Ablation without contact force information PROCEDURE

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.

AF Ablation Procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People who are undergoing an intial AF ablation procedure.

You may qualify if:

• Patients undergoing an initial AF ablation procedure
• Able to sign informed consent and complete the 3 month follow up

You may not qualify if:

• Severe COPD and is unable to receive adenosine therapy during the procedure

Sponsors & Collaborators

• Dhanunjaya Lakkireddy, MD, FACC: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dhanunjaya Lakkireddy, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: January 28, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: July 11, 2016

Record last verified: 2016-07

Locations

US (1)