MediGuide Registry

Abbott

Status: Terminated

Conditions: Cardiac Arrhythmia; Heart Failure

Treatments: Device: MediGuide; Procedure: CRT implantation; Procedure: EP

Study type: Observational

Funder types: Industry

Identifiers

NCT02470312

10051 (Registry Identifier)

Details and patient eligibility

About

The goal of this registry/observational study is to collect data on the clinical utility of MediGuide™ system in cardiac resynchronization therapy (CRT) implantation and electrophysiology (EP) procedures.

Full description

The intent of this worldwide registry/observational study is to understand the utility of the MediGuide™ technology in real world clinical practice during CRT implantation and study-specific-EP procedures. The study should provide an understanding of the effect of MediGuide™ technology on:

• The amount of fluoroscopy time and the radiation exposure
• Total procedure time
• Peri-procedural clinical event rate

Additionally, this study will address the following

• Identification of procedural challenges which may aid in developing future MediGuide tools
• Evaluation of newly available MediGuide tools during the study
• Correlation between MediGuide operator experience and the radiation exposure amount and time

Enrollment: 578 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Anybody coming for CRT or EP procedure utilizing MediGuide system and tools

Exclusion criteria

• None

Trial design

578 participants in 2 patient groups

CRT

Description:

Patients who are undergoing CRT implantation utilizing MediGuide system and tools

Treatment:

Procedure: CRT implantation

Device: MediGuide

EP

Description:

Patients who are undergoing ablation procedures for Atrial Fibrillation, Atrial Flutter, and Ventricular Tachycardia utilizing MediGuide system and tools

Treatment:

Procedure: EP

Device: MediGuide