Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

MediGuide Registry

NCT02470312

Heart Failure Cardiac Arrhythmia

TERMINATED

CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients

NCT01983293

Non-left Bundle Branch Block Ischemic or Non-ischemic Cardiomyopathy

COMPLETED NA

Multi-lead ECG to Effectively Optimize Resynchronization Devices: New CRT Recipients

NCT04083690

Heart Failure, Systolic

UNKNOWN NA

Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study

NCT00632372

Heart Failure

COMPLETED

Selective Coronary Vein Sampling in Left Bundle Branch Block and CRT

NCT02396875

Heart Failure

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MediGuide Arm

Group Type EXPERIMENTAL

MediGuide™

Intervention Type DEVICE

MediGuide™ system will be used to guide CRT implants

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MediGuide™

MediGuide™ system will be used to guide CRT implants

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Meet clinical indication for implantation of an SJM CRT system according to the current European Society of Cardiology (ESC) Guidelines for cardiac and resynchronization therapy
* Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
* Ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria

* Currently participating in any other clinical study
* Have prosthetic valves
* Are pregnant or planning pregnancy in the next 1 month
* Are less than 18 years of age
* Have ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No