Cardiac ArrhythmiasNCT02757430

EnSite Precision™ 2.0 Registry

An observational study of Cardiac Arrhythmias, run by Abbott Medical Devices at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this registry is to assess and characterize the use and performance of the EnSite Precision™ Cardiac Mapping System and the EnSite Precision™ Software V2.0 in a variety of electrophysiological (EP) procedures and clinical settings. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Arrhythmias
What is being tested?: Cardiac Ablation
Type of treatment: Surgery or procedure
How many people: 515 participants
Where: 1 siteItaly
Study dates: 30 Aug 2016to 15 Jul 2017
How long will I take part?: 7 Days
Phase: Observational
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

Study population: Any patient undergoing a cardiac EP mapping and ablation procedure, using the EnSite™ Precision Cardiac Mapping system, is considered eligible.

Who may be able to join

Patients indicated for a cardiac EP study and ablation procedure using a 3D mapping system
Over 18 years of age
Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations

Who cannot join

Contraindication to anticoagulation
Presence of thrombus
Implanted with mechanical prosthetic heart valve
Recent (<3 months) myocardial Infarction or unstable angina or coronary artery by-pass
Pregnant or nursing
Individuals whose willingness to volunteer in a registry, in the judgment of investigator or public authorities, could be unduly influenced by lack of or loss of the autonomy due to immaturity, or mental disability, or adverse personal circumstances, or hierarchical influence

Trial locations and contacts

1 site in 1 country.

Italy1 site

Ospedale Cardinal Massaia di Asti
Asti, 14100

Other trials in Italy

About this study

Official title: EnSite Precision™ Cardiac Mapping System and EnSite Precision™ Software v2.0 Observational Registry

Up to 500 subjects will be enrolled in up to 50 sites worldwide.

Data will be collected at enrollment/baseline, procedure and pre-discharge. There is no long-term follow-up required for this registry.

The anticipated registry enrollment is about 6-7 months.

Read the detailed description

The use of the EnSite Precision™ Cardiac Mapping System will be assessed by collecting feedback from physicians/operators through specific questions.

The performance of the EnSite Precision™ Cardiac Mapping System will be assessed by collecting procedure data and adverse events.

A detailed Data Management Plan will be established to ensure consistency of the data. This document will include procedures used for data review, database cleaning, and issuing and resolving data queries. If appropriate, the Data Management Plan may be updated throughout the registry duration. All revisions will be tracked and document controlled.

Case Report Form data will be captured in a validated electronic database management system hosted by St. Jude Medical.

Centralized monitoring will occur through routine internal data review. This monitoring is designed to identify missing and inconsistent data, data outliers, and potential protocol deviations that may be indicative of site non-compliance. On-site monitoring may occur at the discretion of the sponsor.

Conditions: Cardiac Arrhythmias
Being tested: Cardiac Ablation
Medical subject headings: Arrhythmias, Cardiac

What participants receive

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

Cardiac AblationProcedure or surgery

What is being measured

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

Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy
summarizing the count and percentage of patients with accurate geometry
Measured: during procedure
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: Manual AutoMap™ TurboMap™
Measured: during procedure
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: Manual
Measured: during procedure
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: AutoMap module
Measured: during procedure
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With TurboMap Module Mapping
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: TurboMap module
Measured: during procedure
Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters
mapping points collected and used will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate)
Measured: during procedure
Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability
summarizing the count and percentage of patients with overall system stability
Measured: during procedure
Assessment of the EnSite Precision™ Software V2.0 in Terms of Unrecoverable Shifts
summarizing the count and percentage of patients with unrecoverable shifts
Measured: during procedure

Secondary outcomes (4)

EnSite Precision™ Cardiac Mapping System Assessment
Count and percentage of subjects in whom the mapping system was reported to be excellent, very good, good, poor and N/A
Measured: during procedure
EnSite Precision™ Cardiac Mapping System Assessment
Overall procedure time summarized using mean and standard deviation
Measured: during procedure
Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement
Count and percentage of subjects where the AutoMark feature assisted in identifying gaps in lesion lines
Measured: during procedure
Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement
Count and percentage of subjects where the AutoMark feature was easy to use
Measured: during procedure

Timeline

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

30 Aug 201615 Jul 2017

First posted2 May 2016 (estimated)
Study start30 Aug 2016
Primary completion15 Jul 2017
Study completion15 Jul 2017

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 Cardiac ArrhythmiasStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 515 participants (actual)
Target duration: 7 Days

IDs, dates and publications

ClinicalTrials.gov ID: NCT02757430
Sponsor's protocol ID: SJM-CIP-10111
Status last verified: Feb 2019
First submitted: 8 Apr 2016
Last updated: 6 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 Cardiac Arrhythmias trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EnSite Precision™ Cardiac Mapping System and EnSite Precision™ Software v2.0 Observational Registry
ClinicalTrials.gov ID: NCT02757430
Acronym / sponsor ID: SJM-CIP-10111
Conditions: Cardiac Arrhythmias
Study type: Observational
Recruitment status: Completed
Enrolment: 515 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: 30 Aug 2016 (actual)
Primary completion: 15 Jul 2017 (actual)
Study completion: 15 Jul 2017 (actual)
First posted: 2 May 2016 (estimated)
Results: Posted 6 May 2019

Clinical summary

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

Up to 500 subjects will be enrolled in up to 50 sites worldwide.

Data will be collected at enrollment/baseline, procedure and pre-discharge. There is no long-term follow-up required for this registry.

The anticipated registry enrollment is about 6-7 months.

Detailed description

The use of the EnSite Precision™ Cardiac Mapping System will be assessed by collecting feedback from physicians/operators through specific questions.

The performance of the EnSite Precision™ Cardiac Mapping System will be assessed by collecting procedure data and adverse events.

Case Report Form data will be captured in a validated electronic database management system hosted by St. Jude Medical.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 7 Days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Any patient undergoing a cardiac EP mapping and ablation procedure, using the EnSite™ Precision Cardiac Mapping system, is considered eligible.

Key inclusion criteria (3 listed)

Patients indicated for a cardiac EP study and ablation procedure using a 3D mapping system
Over 18 years of age
Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations

Key exclusion criteria (6 listed)

Contraindication to anticoagulation
Presence of thrombus
Implanted with mechanical prosthetic heart valve
Recent (<3 months) myocardial Infarction or unstable angina or coronary artery by-pass
Pregnant or nursing

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
Cardiac Ablation	Procedure or surgery	–

Primary outcome

Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy
Time frame: during procedure
summarizing the count and percentage of patients with accurate geometry
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters
Time frame: during procedure
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: Manual AutoMap™ TurboMap™
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping
Time frame: during procedure
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: Manual
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping
Time frame: during procedure
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: AutoMap module
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With TurboMap Module Mapping
Time frame: during procedure
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: TurboMap module
Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters
Time frame: during procedure
mapping points collected and used will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate)
Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability
Time frame: during procedure
summarizing the count and percentage of patients with overall system stability
Assessment of the EnSite Precision™ Software V2.0 in Terms of Unrecoverable Shifts
Time frame: during procedure
summarizing the count and percentage of patients with unrecoverable shifts

4 secondary outcomes

EnSite Precision™ Cardiac Mapping System Assessment
Time frame: during procedure
EnSite Precision™ Cardiac Mapping System Assessment
Time frame: during procedure
Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement
Time frame: during procedure
Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement
Time frame: during procedure

Results and safety

Results posted to the registry on 6 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects With EnSite Precision™ Cardiac Mapping	515	503

Primary outcome: Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy

Time frame: during procedure. Count of participants. Unit: Participants

Measure	Subjects With EnSite Precision™ Cardiac Mapping n = 503
Geometry found was anatomically accurate	461
Geometry found was not anatomically accurate	34
Geometry anatomical accuracy not available	8

Primary outcome: Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters

Time frame: during procedure. Mean (Standard Deviation). Unit: min

Measure	All Maps n = 421
Manual Map	14.2 (13.9)
AutoMap	13.1 (11.9)
TurboMap	6.6 (5.7)
Other	4.0 (1.4)

Population analysed: 603 total maps were created in 421 subjects.

Primary outcome: Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping

Time frame: during procedure. Mean (Standard Deviation). Unit: min

Measure	All Manual Maps n = 50
Sinus Rhythm	11.5 (9.8)
Atrial Fibrillation	20.0 (NA)
Atrial Flutter	8.8 (4.3)
Atrial Tachycardia	18.3 (18.2)
Atrioventricular Reentry Tachycardia	10.0 (0.0)
Atrioventricular Nodal Reentry Tachycardia	3.6 (3.3)
Ventricular Tachycardia	23.4 (19.3)
Other	14.6 (11.6)

Population analysed: 62 total Manual maps were created.

Primary outcome: Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping

Time frame: during procedure. Mean (Standard Deviation). Unit: min

Measure	All AutoMap Module Maps n = 399
Sinus Rhythm	14.3 (13.5)
Atrial Fibrillation	11.3 (5.4)
Atrial Flutter	10.1 (7.3)
Atrial Tachycardia	8.4 (5.8)
Atrioventricular Reentry Tachycardia	6.0 (NA)
Atrioventricular Nodal Reentry Tachycardia	11.0 (1.4)
Ventricular Tachycardia	16.3 (16.2)
Other	14.3 (10.8)

Population analysed: 526 total AutoMap Module maps were created.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from the beginning of the procedure through the Pre-discharge visit (maximum of 7 days after procedure).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects With EnSite Precision™ Cardiac Mapping	10 of 503 (2%)	2 of 503 (0.4%)	0 of 503

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cardiac Arrhythmias

Active, not recruitingObservational study
FARAPULSE™ Pulsed Field Ablation System
Paroxysmal AF
Not yet recruiting
Mazdutide for Reducing Atrial Fibrillation Recurrence After Catheter Ablation in Obese Patients
Atrial Fibrillation (AF), Ablation Treatment
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
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Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Arrhythmias, run by Abbott Medical Devices at 1 site in Italy.

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 3 inclusion and 6 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: finished, as of the sponsor's last update on 6 May 2019. 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 Italy. 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 6 May 2019). 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?

Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy (time frame: during procedure). The study lists 8 primary outcomes in all. 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 NCT02757430.

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 6 May 2019.