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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with heart failure and wide QRS | Patients undergoing a cardiac resynchronization therapy procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Pacing | Device |
|
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
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:
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Heart failure patients with wide QRS and undergoing a CRT procedure
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002037 | Bundle-Branch Block |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |