Clinical trial NCT02470312: MediGuide Registry
Official title: MediGuide Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Cardiac Arrhythmia
Keywords: utility of MediGuide system
CRT
EP
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-06-12
Enrollment: 578
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CRT Group All patients from participating sites who are indicated for a CRT-D/P device implant, including an upgrade with a new left ventricular (LV) lead implant and are implanted with St. Jude Medical pulse generators and willing to provide written Informed Consent can be enrolled in this study. Patients can be implanted with non-St. Jude Medical leads

EP Group All patients from participating sites who are indicated for an atrial fibrillation, atrial flutter or ventricular tachycardia (VT) ablation procedure for which market approved MediGuide™-enabled ablation catheter is available and willing to provide written Informed Consent can be enrolled in this study.

Brief summary: 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Amount of Fluoroscopy Time
timeFrame: Expected time frame is day 1 of the study
measure: Periprocedural Adverse Event
timeFrame: From the day of CRT and EP procedure until patient discharge, expected stay is an average of 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: John C Lincoln North Mountain Hospital
state: Arizona
city: Athens
country: United States
facility: Athens Regional Medical Center
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Medical Center
state: Georgia
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Dallas
country: United States
facility: North Texas Heart Center
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Southwest Hospital
state: Texas
city: East Brisbane
country: Australia
facility: St. Andrews War Memorial Hospital
city: Linz
country: Austria
facility: A. ö. Krankenhaus der Elisabethinen Linz
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Ingolstadt
country: Germany
facility: Klinikum Inglostadt
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: München
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern
city: Villingen-Schwenningen
country: Germany
facility: Kliniken Villingen-Schwenningen
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
Study officials:
affiliation: Abbott
name: Kristin Ruffner, PhD
role: STUDY_DIRECTOR
References: