Heart FailureNCT00187213
B-Left HF: Biventricular Versus Left Univentricular Pacing With Implantable Cardiac Defibrillator (ICD) Back-Up in Heart Failure Patients
A study testing Cardiac Resynchronization Therapy in people with Heart Failure and Ventricular Dysfunction, run by Abbott Medical Devices at 1 site in France.
Trial summary
The purpose of this study is to demonstrate that biventricular pacing (BiV) and left univentricular (left ventricular [LV] only) pacing are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D) device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Ventricular Dysfunction, Heart Diseases
- What is being tested?
- Cardiac Resynchronization Therapy
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Dec 2004to Jan 2008
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have an approved indication for implantation of an ICD for treatment of a life-threatening ventricular tachyarrhythmia(s)
- Have advanced heart failure with a New York Heart Association (NYHA) classification of III or IV, despite receiving a minimum of 30 days of stable optimal pharmacological therapy
- Have a ventricular conduction delay manifested as a QRS width >= 130 ms
- Have a left ventricular end diastolic diameter (LVEDD) >= 55 mm
- Have a left ventricular ejection fraction (LVEF) <= 35%
Who cannot join
- Have a CRT device already implanted
- Have a standard indication for bradycardia pacing
- Have a history of chronic atrial fibrillation [AF] (continuous AF lasting > 1 month) within 1 year prior to enrollment or have undergone cardioversion for AF in the past month)
- Have the ability to walk > 450 meters during the 6-minute walk test
- Have uncorrected primary valvular disease
- Have had a recent myocardial infarction, unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty [PTCA] or coronary artery bypass graft [CABG]) within 1 month of enrollment
Show all 11Show fewer
- Have had cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment
- Have a life expectancy of less than one year
- Are unable to comply with the follow-up schedule and tests
- Are minors (age below 18 years)
- Are pregnant or are planning for pregnancy in the next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biventricular Versus Left Univentricular Pacing With ICD Back-up in Heart Failure Patients
The purpose of this study is to demonstrate that biventricular pacing (BiV) and left univentricular (left ventricular [LV] only) pacing are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D) device.
The hypothesis to be tested by this clinical investigation is that patients indicated for an ICD with cardiac resynchronization therapy respond as well to LV only pacing as to BiV pacing.
- Conditions
- Heart Failure, Ventricular Dysfunction, Heart Diseases
- Being tested
- Cardiac Resynchronization Therapy
- Keywords
- Ventricular Dyssynchrony
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization TherapyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to demonstrate that left univentricular pacing is equivalent to biventricular pacing in improving the functional capacity and inducing reverse remodeling.
Secondary outcomes (1)
The secondary objective of this clinical investigation is to evaluate the proportion of improved patients in each group, using the Heart Failure Clinical Composite Response.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJul 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christophe Leclercq, MD, PhD, Principal investigator, CHU Pontchaillou Rennes France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187213
- Sponsor's protocol ID
- CR03019HF
- Status last verified
- Feb 2019
- First submitted
- 13 Sep 2005
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boriani G, Kranig W, Donal E, Calo L, Casella M, Delarche N, Lozano IF, Ansalone G, Biffi M, Boulogne E, Leclercq C; B-LEFT HF study group. A randomized double-blind comparison of biventricular versus left ventricular stimulation for cardiac resynchronization therapy: the Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial. Am Heart J. 2010 Jun;159(6):1052-1058.e1. doi: 10.1016/j.ahj.2010.03.008.
PubMed 20569719
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biventricular Versus Left Univentricular Pacing With ICD Back-up in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00187213
- Acronym / sponsor ID
- CR03019HF
- Conditions
- Heart Failure, Ventricular Dysfunction, Heart Diseases
- Keywords
- Ventricular Dyssynchrony
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 16 Sep 2005 (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 study is to demonstrate that biventricular pacing (BiV) and left univentricular (left ventricular [LV] only) pacing are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D) device.
The hypothesis to be tested by this clinical investigation is that patients indicated for an ICD with cardiac resynchronization therapy respond as well to LV only pacing as to BiV pacing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have an approved indication for implantation of an ICD for treatment of a life-threatening ventricular tachyarrhythmia(s)
- Have advanced heart failure with a New York Heart Association (NYHA) classification of III or IV, despite receiving a minimum of 30 days of stable optimal pharmacological therapy
- Have a ventricular conduction delay manifested as a QRS width >= 130 ms
- Have a left ventricular end diastolic diameter (LVEDD) >= 55 mm
- Have a left ventricular ejection fraction (LVEF) <= 35%
Key exclusion criteria (11 listed)
- Have a CRT device already implanted
- Have a standard indication for bradycardia pacing
- Have a history of chronic atrial fibrillation [AF] (continuous AF lasting > 1 month) within 1 year prior to enrollment or have undergone cardioversion for AF in the past month)
- Have the ability to walk > 450 meters during the 6-minute walk test
- Have uncorrected primary valvular disease
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 Resynchronization Therapy | Device | – |
Primary outcome
The primary objective is to demonstrate that left univentricular pacing is equivalent to biventricular pacing in improving the functional capacity and inducing reverse remodeling.
1 secondary outcome
The secondary objective of this clinical investigation is to evaluate the proportion of improved patients in each group, using the Heart Failure Clinical Composite Response.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Derived from this study: PubMed 20569719Boriani G, Kranig W, Donal E, Calo L, Casella M, Delarche N, Lozano IF, Ansalone G, Biffi M, Boulogne E, Leclercq C; B-LEFT HF study group. A randomized double-blind comparison of biventricular versus left ventricular stimulation for cardiac resynchronization therapy: the Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial. Am Heart J. 2010 Jun;159(6):1052-1058.e1. doi: 10.1016/j.ahj.2010.03.008.
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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.
Christophe Leclercq, MD, PhD principal investigator
CHU Pontchaillou Rennes France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Resynchronization Therapy in people with Heart Failure and Ventricular Dysfunction, run by Abbott Medical Devices at 1 site in France.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 4 Feb 2019. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
The primary objective is to demonstrate that left univentricular pacing is equivalent to biventricular pacing in improving the functional capacity and inducing reverse remodeling.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00187213, which also lists 1 linked publication.
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 4 Feb 2019.