Heart Failure
Conditions
Brief summary
The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.
Interventions
DEVICEMediGuide™
MediGuide™ system will be used to guide CRT implants
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The performance of the MediGuide™ system during CRT implant | 1 month post CRT implant | Performance will be assessed in terms occurence of adverse events, easy of use and potential benefits. |
Outcome results
None listed