High Septal Pacing for Cardiac Resynchronization Therapy

Heart Failure Clinical Trial

— HISTORY  

Official title:

High Septal Pacing for Cardiac Resynchronization Therapy Acute Research Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01325480
• Other study ID #: HISTORY - 1209
• Status: Terminated
• Phase: Phase 0
• First received: March 28, 2011
• Last updated: June 20, 2012
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: HKU/ HA HKW IRB (The University of Hong Kong / Hospital Authority, Hong Kong West Cluster)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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• Patients unwilling or incapable of signing the informed consent, or patients having previously withdrawn their consent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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bundle-Branch Block
• Heart Disease
• Heart Failure
• Left Bundle Branch Block

Intervention

Device:
• Cardiac Pacing

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Hong Kong,