Heart FailureHISTORYNCT01325480
High Septal Pacing for Cardiac Resynchronization Therapy
An observational study of Heart Failure and Left Bundle Branch Block, run by Boston Scientific Corporation at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure, Left Bundle Branch Block, Heart Disease
- What is being tested?
- Cardiac Pacing
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2011to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart failure patients with wide QRS and undergoing a CRT procedure
Who may be able to join
- 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.
Who cannot join
- Patients unwilling or incapable of signing the informed consent, or patients having previously withdrawn their consent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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Septal Pacing for Cardiac Resynchronization Therapy Acute Research Study
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.
Read the 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.
- Conditions
- Heart Failure, Left Bundle Branch Block, Heart Disease
- Being tested
- Cardiac Pacing
- Keywords
- Cardiac Resynchronization Therapy, Pacing, His Bundle
- Medical subject headings
- Heart Failure, Bundle-Branch Block, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac PacingDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients with heart failure and wide QRS | Patients undergoing a cardiac resynchronization therapy procedure Receives: Device: Cardiac Pacing |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325480
- Sponsor's protocol ID
- HISTORY - 1209
- Acronym
- HISTORY
- Status last verified
- Jun 2012
- First submitted
- 28 Mar 2011
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Septal Pacing for Cardiac Resynchronization Therapy Acute Research Study
- ClinicalTrials.gov ID
- NCT01325480
- Acronym / sponsor ID
- HISTORY / HISTORY - 1209
- Conditions
- Heart Failure, Left Bundle Branch Block, Heart Disease
- Keywords
- Cardiac Resynchronization Therapy, Pacing, His Bundle
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with heart failure and wide QRS | – | Device: Cardiac PacingPatients undergoing a cardiac resynchronization therapy procedure |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients with wide QRS and undergoing a CRT procedure
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Pacing | Device | Patients with heart failure and wide QRS |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Left Bundle Branch Block, run by Boston Scientific Corporation at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2012.