Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic Cardiac Rhythm and Heart Failure
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient is willing and able to provide written informed consent
Subject is at least 18 years of age
Patient is willing and able to comply with the protocol, including follow-up visits
The patient's medical records must be accessible by the enrolling site over the follow-up period
Standard CRT-D or CRT-P indications, with a preference for IVCD and non-LBBB patients, where LBBB is defined according to Strauss criteria.
De-novo CRT implant, including upgrade from pacemaker or ICD
You may not be if
Subject has persistent or permanent AF (Atrial Fibrillation)/AFL (Atrial Flutter)
Subject has 2nd or 3rd degree AV (Atrioventricular) Block
Subject has RBBB with no additional conduction block
Subject has intrinsic (non-paced) QRS width less than or equal to 120 ms
Subject experienced MI within 40 days prior to enrollment
Subject underwent valve surgery, within 90 days prior to enrollment
Subject is post heart transplantation or is actively listed on the transplantation list
Subject is implanted with a LV assist device
Subject has severe renal disease
Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure
Subject has severe aortic stenosis (with a valve area of \<1.0 cm or significant valve disease expected to be operated within study period)
Subject has severe aortic calcification or severe peripheral arterial disease
Subject has complex and uncorrected congenital heart disease
Subject has mechanical heart valve
Pregnant or breastfeeding woman (pregnancy test required for woman of child-bearing potential and who are not on a reliable form of birth regulation method or abstinence)
Subject is enrolled in another study that could confound the results of this study without documented pre-approval from Medtronic study manager
Clareo Health | Conduction System Pacing Optimized Therapy
