NCT02028143

Brief Summary

Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of Radiofrequency Ablation of Atrial Fibrillation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

December 31, 2013

Last Update Submit

April 23, 2018

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • number of lesions requiring ablation to obtain Electrical Isolation PV System

    to assess the number of lesions requiring ablation to obtain Electrical Isolation PV system

    during procedure

Secondary Outcomes (1)

  • to assess number of lesions to obtain Electrical Isolation PV system

    during procedure

Other Outcomes (1)

  • Safety-Cardiac perforation, emboli, fistula formation

    during procedure

Study Arms (2)

Study arm

EXPERIMENTAL

The study arm group will have the ICE catheter placed through one of two existing 8F sheaths already in the left atrium. The ICE catheter will be exchanged in the sheath utilizing the lasso multipolar mapping catheter during left pulmonary vein ablation lines. During exchange, suction and irrigation techniques will be utilized to avoid any air or thrombus embolization. All patients will have standard anticoagulation during the procedure with heparin infusion adjusted to an activated clotting time (ACT) of 350-400. The left sided ICE catheter will be adjusted to visualize left sided structures, ablation tip and tissue interface, and adjacent noncardiac structures such as the esophagus during radiofrequency ablation of the left pulmonary vein system.

Device: Biosense Webster irrigated tip catheterProcedure: ICE catheter placed through one of two existing 8F sheaths

Control arm

ACTIVE COMPARATOR

The control arm group will receive standard pulmonary vein isolation (PVI) procedure utilizing intracardiac guided ultrasound (ICE) placed within the right atrium via the femoral vein.

Device: Biosense Webster irrigated tip catheterProcedure: Pulmonary vein isolation

Interventions

ICE catheter placed through one of two existing 8F sheathsPROCEDURE
Study arm
Biosense Webster irrigated tip catheterDEVICE

The second group (study group) will have the ICE catheter placed through one of two existing 8F sheaths already in the left atrium. The ICE catheter will be exchanged in the sheath utilizing the lasso multipolar mapping catheter during left pulmonary vein ablation lines. During exchange, suction and irrigation techniques will be utilized to avoid any air or thrombus embolization. All patients will have standard anticoagulation during the procedure with heparin infusion adjusted to an activated clotting time (ACT) of 350-400. The left sided ICE catheter will be adjusted to visualize left sided structures, ablation tip and tissue interface, and adjacent noncardiac structures such as the esophagus during radiofrequency ablation of the left pulmonary vein system.

Also known as: 3.5mm Biosense Webster irrigated tip catheter.
Study arm
Pulmonary vein isolationPROCEDURE
Control arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 80 years
  • Recommended for radiofrequency ablation of nonvalvular atrial fibrillation

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gregory Jones, MD

    Wellmont CVA Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Gregory Jones, MD, FACC

Study Record Dates

First Submitted

December 31, 2013

First Posted

January 7, 2014

Study Start

November 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2016

Last Updated

April 24, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)