NCT03370536

Brief Summary

This is a prospective, multi-center, non-randomized, un-blinded, observational trial.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
terminated

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, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2018

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 10, 2020

Completed
Last Updated

February 10, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

December 4, 2017

Results QC Date

January 28, 2020

Last Update Submit

January 28, 2020

Conditions

Atrial FibrillationPersistent Atrial Fibrillation

Keywords

Atrial FibrillationPersistent Atrial FibrillationAFIBArrhythmia

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who no Longer Has Recurrent At/AF

    Freedom from recurrent At/AF

    at 12 months

Secondary Outcomes (5)

  • Number of Drivers

    Baseline

  • Size of Drivers

    Baseline

  • Percent Change of Driver Regions

    Baseline and 1 year

  • AF Termination Rate

    post ablation inducibility of AF after 5 minutes of burst pacing

  • Total Procedure Time

    within 24 hours after the procedure is completed the time is calculated

Study Arms (1)

Patients with AF

EXPERIMENTAL

Patients with AF and planned to undergo first catheter procedure

Device: CardioInsight ECGI Mapping SystemProcedure: AF ablationDrug: Ibutilide

Interventions

CardioInsight ECGI Mapping SystemDEVICE

The CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart.

Also known as: ECGi mapping
Patients with AF
AF ablationPROCEDURE

Empiric ablation (CFAE or linear ablation) is not permitted

Also known as: Biosense Thermocool SF, Biosense Smart Touch SF (STSF)
Patients with AF
IbutilideDRUG

Progressive doses of Ibutilide administered (0.25mg, then 0.25mg, then 0.5mg)

Patients with AF

Eligibility Criteria

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

You may qualify if:

  • ≥ 18 years of age.
  • ° Symptomatic persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication Persistent AF - defined as Persistent: AF that is sustained \> 7 days. Episodes of AF which are terminated by electrical or pharmacologic cardioversion after ≥ 48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes.
  • Planned to undergo first catheter ablation procedure ( prior atrial flutter typical is allowed)
  • Ability to understand the requirements of the study and sign the informed consent form.
  • Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
  • Projected lifespan greater than 1 year

You may not qualify if:

  • They have baseline prolonged QT or renal failure precluding safe used of ibutilide
  • Rheumatic heart disease,
  • Current intra-cardiac thrombus,
  • History of MI or CABG within 6 weeks;
  • Class IV HF,
  • Unable to sign consent
  • Projected lifespan of \< 1 year
  • Women known to be pregnant or to have positive beta-HCG.
  • Participation in another study that would interfere with this study.
  • Unstable Angina
  • Recent cerebral ischemic events
  • Contraindication to anticoagulation
  • Prior history of polymorphic ventricular tachycardia or torsades de pointes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Interventions

ibutilide

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Vivek Reddy
Organization
Icahn School of Medicine at Mount Sinai
vivek.reddy@mountsinai.org
(212) 241-7114

Study Officials

  • Jacob Koruth, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Vivek Reddy, MD

    Icahn School of Medicine at Mount Sinai

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 12, 2017

Study Start

November 1, 2017

Primary Completion

July 18, 2018

Study Completion

July 18, 2018

Last Updated

February 10, 2020

Results First Posted

February 10, 2020

Record last verified: 2020-01

Locations

US(1)