EnSite Precision™ 2.0 Registry

NCT02757430 | Completed Results

• 1 other identifier: SJM-CIP-10111
• Study Type: observational
• Target: 515
• Locations: 1 country
• Sites: 1

Brief 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. This registry will assess the clinical performance of the system in a controlled, real-world environment after commercial release. 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.

Conditions

Cardiac Arrhythmias

Outcome Measures

Primary Outcomes (8)

• Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy

  summarizing the count and percentage of patients with accurate geometry

  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™

  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

  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

  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

  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)

  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

  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

  during procedure

Secondary Outcomes (4)

• EnSite Precision™ Cardiac Mapping System Assessment

  during procedure

• EnSite Precision™ Cardiac Mapping System Assessment

  during procedure

• Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement

  during procedure

• Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement

  during procedure

Interventions

Cardiac Ablation PROCEDURE

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Ospedale Cardinal Massaia di Asti

Asti, 14100, Italy

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Clinical Research Scientist
• Organization: Abbott

amber.miller@abbott.com

6517562885

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: May 2, 2016
• Study Start: August 30, 2016
• Primary Completion: July 15, 2017
• Study Completion: July 15, 2017
• Last Updated: May 6, 2019
• Results First Posted: May 6, 2019

Record last verified: 2019-02

Locations

IT (1)