EnSite Precision Observational Study

NCT03260244 | Completed Results

• 1 other identifier: SJM-CIP-10159
• Study Type: observational
• Target: 1,065
• Locations: 1 country
• Sites: 7

Brief Summary

This document is a clinical investigation plan (CIP) for the EnSite Precision Observational Study. This clinical study is intended to quantify and characterize the usage of the EnSite Precision™ Cardiac Mapping System (Software version 2.0.1 or higher) in a real-world environment. This study will be conducted in patients who are indicated for a cardiac electrophysiological (EP) mapping and radio frequency ablation procedure using a three-dimensional system.

Conditions

Cardiac Arrhythmia

Keywords

atrial fibrillation; atrial flutter; supraventricular tachycardia; ventricular tachycardia; premature ventricular contractions; cardiac mapping system

Outcome Measures

Primary Outcomes (2)

• Rate of Acute Success Based on Pre-defined Procedural Endpoints

  The number and proportion of subjects with acute success will be summarized. Acute success was defined as the physician's goal or intention for the procedure.

  during procedure

• Freedom From Arrhythmia Recurrence

  This analysis will be performed using the Kaplan-Meier (KM) analyses. The start date is the date of the index procedure. For subjects who do not experience an event, their follow up duration will be defined from the start date to the date of death, withdrawal, or last follow-up, whichever occurred later.

  From date of procedure until the date of first documented arrhythmia recurrence or date of study completion or withdrawal for any cause, whichever came first, assessed up to 12 months

Interventions

cardiac mapping and radiofrequency ablation procedure PROCEDURE

It is a minimally invasive procedure which can be performed using either general or conscious sedation. During catheter ablation, catheters (narrow, flexible tubes) are inserted into a blood vessel, often through a site in the groin (upper thigh) or neck, and guided through the vein until they reach the heart. Small electrodes on the tip of the catheters stimulate and record the heart's activity. This test, called an electrophysiology study (EPS), allows the doctor to pinpoint the exact location of the short circuit. Another word for pinpointing the exact location of the short circuit is 'mapping', for which precision is a key requirement to maximize a successful outcome. Once the location is confirmed, the short circuit is either destroyed (to reopen the electrical pathway) or blocked (to prevent it from sending faulty signals to the rest of the heart).

Eligibility Criteria

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

Study Population

The intended population for this clinical study is patients over the age of 18 years who are eligible for a cardiac electrophysiology mapping and radiofrequency ablation procedure using the EnSite Precision™ Cardiac Mapping System.

You may qualify if:

• Indicated for a cardiac electrophysiology mapping and radiofrequency ablation procedure using a 3-dimensional mapping system per Instructions for Use
• Over 18 years of age
• Able to provide informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule

You may not qualify if:

• Patients who are only presenting with:
• Atrioventricular Nodal Reentrant Tachycardia (AVNRT)
• Atrioventricular Reentrant Tachycardia (AVRT)
• Planned cryoablation procedure
• Implanted with a neurostimulator
• Contraindication to anticoagulation
• Known presence of cardiac thrombus
• Recent (\<3 months) myocardial infarction or unstable angina or coronary artery by-pass
• Currently enrolled in a clinical study/investigation evaluating another device or drug that would confound the results of this study
• Pregnant or nursing
• Individuals whose willingness to volunteer in a study, in the judgement 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 (7)

Baptist Medical Center Princeton

Birmingham, Alabama, 35211, United States

Location

Cardiology Associates of North East Arkansas

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Cardiology

Little Rock, Arkansas, 72205, United States

Location

Bethesda Memorial Hospital

Boynton Beach, Florida, 33435, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Bryan LGH Medical Center East

Lincoln, Nebraska, 68506, United States

Location

Aurora Medical Group

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter; Tachycardia, Supraventricular; Tachycardia, Ventricular; Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease; Cardiac Complexes, Premature

Results Point of Contact

• Title: Associate Director, Clinical Research, Electrophysiology
• Organization: Abbott

anne.sarver@abbott.com

651-756-3813

Study Officials

• Kristin Ruffner, PhD

  Abbott

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: August 24, 2017
• Study Start: September 12, 2017
• Primary Completion: January 17, 2020
• Study Completion: March 31, 2020
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)