Clinical Utility and Validation of the Rhythmia Mapping System for the Treatment of Cardiac Arrhythmias

NCT03094221 | Completed

• 1 other identifier: 2014P000240
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare two different types of three-dimensional electroanatomic mapping systems used for the treatment of cardiac arrhythmias. The systems will be compared in regards to its ability to successfully map and ablate a clinical arrhythmia, as well as the time invested in this activity.

Conditions

Cardiac Arrhythmias; Electroanatomic Mapping; Cardiac Ablation

Outcome Measures

Primary Outcomes (2)

• Arrhythmia Mapping (Yes/No)

  Ability to successfully map and characterize clinical arrhythmia as confirmed with conventional techniques.

  Enrollment (Clinical Procedure)

• Ablation Success - Elimination of Clinical Arrhythmia (Yes/No)

  Ability to ablate and eliminate the clinical arrhythmia

  Enrollment (Clinical Procedure)

Secondary Outcomes (1)

• Mapping Time (minutes)

  Enrollment (Clinical Procedure)

Study Arms (1)

Arrhythmia Mapping

The study sample includes patients referred for three different types of cardiac arrhythmias, which will be the studied categories: 1) atrial flutter/fibrillation, 2) atrial tachycardia, 3) ventricular tachycardia. Patients will undergo standard of care mapping and ablation procedures.

Device: Rhythmia Mapping System

Interventions

Rhythmia Mapping System DEVICE

Arrhythmia mapping will be performed using the Rhythmia mapping system, including its mapping catheter, either in the atria or ventricles depending on the clinical arrhythmia being treated. Detailed mapping will be performed to determine tissue voltage and arrhythmia mechanism/location according to standard clinical practice. This part of the study will take approximately 90-120 minutes. The catheter position and contact will be visualized with intra-cardiac echocardiography, which is also routinely used during these procedures, and to monitor for potential clinically related complications. Images will be recorded to establish criteria for mapping.

Arrhythmia Mapping

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

This study will enroll patients who present for standard of care catheter ablation procedures for atrial and ventricular arrhythmias.

You may qualify if:

• Patients above the age of 18 years old.
• Patients with the diagnosis of atrial or ventricular arrhythmias presenting for electrophysiology study.
• Patients must be able to understand and critically review the informed consent form.

You may not qualify if:

• Patients whom are unable to provide informed consent.
• Patients with ventricular hypertrophy (LV septum thickness ≥15mm).
• Patients with prosthetic or stenotic cardiac valves present in the chamber where endocardial mapping is planned
• Patients with active systemic infections
• Patients that are pregnant or lactating.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• Elad Anter, MD

  Beth Israel Deaconess Medical Center, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: March 29, 2017
• Study Start: January 13, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

US (1)