High Septal Pacing for Cardiac Resynchronization Therapy
High Septal Pacing for Cardiac Resynchronization Therapy
The purpose of this acute study is to perform a preliminary investigation of high septal
 right ventricular pacing in the vicinity of the His bundle region as an alternate or
 adjunctive means for cardiac resynchronization in patients with heart failure and wide QRS.
The HISTORY Study is an acute, cross-sectional, multi-center, feasibility study with a
 randomized within patient test sequence designed to characterize the effects of high septal
 right ventricular pacing in the vicinity of the His bundle region compared to conventional
 biventricular pacing for cardiac resynchronization therapy.
Inclusion Criteria:

 -  50 years of age or older

 -  Patients willing and capable of providing informed consent, participating in all
 testing associated with this clinical investigation

 -  Patients undergoing a CRT implant procedure (pacemaker or defibrillator) for one of
 the following reasons

 -  Indicated for a new device

 -  Device upgrade

 -  Device replacement

 -  Lead revision

 -  Note: recognized indications for CRT-P and CRT-D as of October 2009 are valid for
 inclusion in this study. Should new indications become approved during the study
 conduct; those will also be applied within the inclusion criteria.

 Exclusion Criteria:

 -  Patients unwilling or incapable of signing the informed consent, or patients having
 previously withdrawn their consent

 -  Patients in AF that cannot be cardioverted for the study

 -  RBBB pattern

 -  Sustained, uncontrolled ventricular tachycardia

 -  Sinus rhythm < 30 bpm or >100 bpm

 -  Complete AV node block

 -  Second degree AV block

 -  Women who are pregnant or plan to become pregnant during the study (method of
 assessment upon physician's discretion);

 -  History of (hemorrhagic) cerebro-vascular accident or TIA