NCT01325480

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 21, 2012

Status Verified

June 1, 2012

Enrollment Period

8 months

First QC Date

March 28, 2011

Last Update Submit

June 20, 2012

Conditions

Heart FailureLeft Bundle Branch BlockHeart Disease

Keywords

Cardiac Resynchronization TherapyPacingHis Bundle

Study Arms (1)

Patients with heart failure and wide QRS

Patients undergoing a cardiac resynchronization therapy procedure

Device: Cardiac Pacing

Interventions

Cardiac PacingDEVICE
Patients with heart failure and wide QRS

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart failure patients with wide QRS and undergoing a CRT procedure

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Heart FailureBundle-Branch BlockHeart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesHeart BlockArrhythmias, CardiacCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 29, 2011

Study Start

August 1, 2011

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

June 21, 2012

Record last verified: 2012-06

Locations

HK(1)