High Septal Pacing for Cardiac Resynchronization Therapy

Terminated

• Conditions: Heart Failure; Left Bundle Branch Block; Heart Disease
• Interventions: Device: Cardiac Pacing

• Registration Number: NCT01325480
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Study Start: 2011-08
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-20
• Last Update Posted: 2012-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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• Patients unwilling or incapable of signing the informed consent, or patients having previously withdrawn their consent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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with heart failure and wide QRS	Cardiac Pacing	Patients undergoing a cardiac resynchronization therapy procedure

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong