High Septal Pacing for Cardiac Resynchronization Therapy

High Septal Pacing for Cardiac Resynchronization Therapy Acute Research Study

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01325480

Acronym

HISTORY

Enrollment

Registered

2011-03-29

Start date

2011-08-31

Completion date

2012-05-31

Last updated

2012-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disease, Heart Failure, Left Bundle Branch Block

Keywords

Cardiac Resynchronization Therapy, Pacing, His Bundle

Brief summary

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.

Detailed description

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.

Interventions

DEVICECardiac Pacing

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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* Patients unwilling or incapable of signing the informed consent, or patients having previously withdrawn their consent * Patients in AF that cannot be cardioverted for the study * RBBB pattern * Sustained, uncontrolled ventricular tachycardia * Sinus rhythm \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

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026