Atrial FibrillationNCT03370536

ECGi Ibutilide: Effect of Ibutilide on AF Source Location and Organization

A study testing CardioInsight ECGI Mapping System, AF ablation and Ibutilide in people with Atrial Fibrillation and Persistent Atrial Fibrillation, run by Vivek Reddy at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a prospective, multi-center, non-randomized, un-blinded, observational trial. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation, Persistent Atrial Fibrillation
What is being tested?: CardioInsight ECGI Mapping System, AF ablation and Ibutilide
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2017to 18 Jul 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

Official title: Panoramic ECGi to Guide Ablation of Non-Paroxysmal AF: Effect of Ibutilide on AF Source Location and Organization

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

Read the detailed description

This prospective, multicenter observational study will examine the ability of ECGi mapping to

Effect of Ibutilide on the number and size of the driver domains
Effect of ablation of Ibutilide-organized driver domains
Effect of PV isolation on driver domains

The researchers hypothesize that this approach will lead to successful arrhythmia control .

Conditions: Atrial Fibrillation, Persistent Atrial Fibrillation
Being tested: CardioInsight ECGI Mapping System, AF ablation, Ibutilide
Keywords: Atrial Fibrillation, Persistent Atrial Fibrillation, AFIB, Arrhythmia
Medical subject headings: Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CardioInsight ECGI Mapping SystemDevice
Also called ECGi mapping
The CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart.
AF ablationProcedure or surgery
Also called Biosense Thermocool SF, Biosense Smart Touch SF (STSF)
Empiric ablation (CFAE or linear ablation) is not permitted
IbutilideDrug
Progressive doses of Ibutilide administered (0.25mg, then 0.25mg, then 0.5mg)

Study groups in NCT03370536
Study group	Role	What they receive
Patients with AF	Experimental	Patients with AF and planned to undergo first catheter procedure Receives: Device: CardioInsight ECGI Mapping System; Procedure: AF ablation; Drug: Ibutilide

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who no Longer Has Recurrent At/AF
Freedom from recurrent At/AF
Measured: at 12 months

Secondary outcomes (5)

Number of Drivers
Number of drivers identified
Measured: Baseline
Size of Drivers
Size of drivers ablated
Measured: Baseline
Percent Change of Driver Regions
Percent change of driver regions after ibutilide
Measured: Baseline and 1 year
AF Termination Rate
AF termination rate is defined as AF termination to AT/SR (Atrial Tachycardia/Sinus Rhythm)
Measured: post ablation inducibility of AF after 5 minutes of burst pacing
Total Procedure Time
Total duration of RF ablation/fluoroscopy time/exposure procedure time
Measured: within 24 hours after the procedure is completed the time is calculated

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201718 Jul 2018

First posted12 Dec 2017
Study start1 Nov 2017
Primary completion18 Jul 2018
Study completion18 Jul 2018

Why it stopped: 1 patient enrolled (consented) but screen failed. Study stopped as unable to enroll.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03370536
Sponsor's protocol ID: GCO 40-5004
Status last verified: Jan 2020
First submitted: 4 Dec 2017
Last updated: 10 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Panoramic ECGi to Guide Ablation of Non-Paroxysmal AF: Effect of Ibutilide on AF Source Location and Organization
ClinicalTrials.gov ID: NCT03370536
Acronym / sponsor ID: GCO 40-5004
Conditions: Atrial Fibrillation, Persistent Atrial Fibrillation
Keywords: Atrial Fibrillation, Persistent Atrial Fibrillation, AFIB, Arrhythmia
Study type: Interventional
Recruitment status: TerminatedReason stopped: 1 patient enrolled (consented) but screen failed. Study stopped as unable to enroll.
Enrolment: 1 participants (actual)
Lead sponsor: Vivek ReddyUniversity, hospital or other
Collaborators: Medtronic
Study start: 1 Nov 2017 (actual)
Primary completion: 18 Jul 2018 (actual)
Study completion: 18 Jul 2018 (actual)
First posted: 12 Dec 2017 (actual)
Results: Posted 10 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

This prospective, multicenter observational study will examine the ability of ECGi mapping to

Effect of Ibutilide on the number and size of the driver domains
Effect of ablation of Ibutilide-organized driver domains
Effect of PV isolation on driver domains

The researchers hypothesize that this approach will lead to successful arrhythmia control .

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients with AF	Experimental	Device: CardioInsight ECGI Mapping System, Procedure: AF ablation, Drug: IbutilidePatients with AF and planned to undergo first catheter procedure

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

≥ 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.
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

Key exclusion criteria (13 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CardioInsight ECGI Mapping SystemAlso: ECGi mappingThe CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart.	Device	Patients with AF
AF ablationAlso: Biosense Thermocool SF, Biosense Smart Touch SF (STSF)Empiric ablation (CFAE or linear ablation) is not permitted	Procedure or surgery	Patients with AF
IbutilideProgressive doses of Ibutilide administered (0.25mg, then 0.25mg, then 0.5mg)	Drug	Patients with AF

Primary outcome

Number of Participants Who no Longer Has Recurrent At/AF
Time frame: at 12 months
Freedom from recurrent At/AF

5 secondary outcomes

Number of Drivers
Time frame: Baseline
Size of Drivers
Time frame: Baseline
Percent Change of Driver Regions
Time frame: Baseline and 1 year
AF Termination Rate
Time frame: post ablation inducibility of AF after 5 minutes of burst pacing
Total Procedure Time
Time frame: within 24 hours after the procedure is completed the time is calculated

Results and safety

Results posted to the registry on 10 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With AF	1	0

Primary outcome: Number of Participants Who no Longer Has Recurrent At/AF

Time frame: at 12 months

Population analysed: Participant screen failed

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Atrial Fibrillation (AF)	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atrial Fibrillation

Active, not recruiting
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RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruitingPhase 4
A Comparison of Beta-blockers and Calcium Channel Blockers in Atrial Fibrillation
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Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
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Dual-Energy Lattice-Tip Assisted Marshall-Plan Strategy in Redo Persistent Atrial Fibrillation Ablation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jacob Koruth, MD principal investigator

Icahn School of Medicine at Mount Sinai

Vivek Reddy, MD study chair

Icahn School of Medicine at Mount Sinai

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CardioInsight ECGI Mapping System, AF ablation and Ibutilide in people with Atrial Fibrillation and Persistent Atrial Fibrillation, run by Vivek Reddy at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who no Longer Has Recurrent At/AF (time frame: at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03370536.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.