Heart Failure, CongestivePhase 2/3NCT00387803
Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation
A Phase 2/3 study testing Cardiac Resynchronization Therapy with Defibrillation in people with Heart Failure, Congestive and Ventricular Fibrillation, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
The purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Congestive, Ventricular Fibrillation, Tachycardia, Ventricular
- What is being tested?
- Cardiac Resynchronization Therapy with Defibrillation
- Type of treatment
- Medical device
- How many people
- 581 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1998to Aug 2001
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Symptomatic heart failure
- Left ventricular ejection fraction <= 35%
- QRS width >= 120 ms
- Indicated for an implantable cardioverter defibrillator
Who cannot join
- Indicated for a pacemaker
- Atrial tachyarrhythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VENTAK CHF/CONTAK CD Biventricular Pacing Study
The purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.
Read the detailed description
Patients enrolled received a device with cardiac resynchronization therapy (CRT) and defibrillation. Patients were randomized to CRT on or off for up to six months and evaluated for mortality, hospitalization, and functional outcomes including exercise capacity, quality of life, symptomatic status, and echocardiographic analysis.
- Being tested
- Cardiac Resynchronization Therapy with Defibrillation
- Medical subject headings
- Heart Failure, Ventricular Fibrillation, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization Therapy with DefibrillationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia
Secondary outcomes (5)
Peak VO2
NYHA Class
Six minute walk distance
Quality of life
Echocardiographic measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startFeb 1998
- Study completionAug 2001
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 Failure, CongestiveStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 581 participants
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Higgins, MD, Principal investigator, Scripps Memorial HospitalLeslie A Saxon, MD, Principal investigator, University of California San Francisco Medical CenterJohn Boehmer, MD, Principal investigator, Milton S. Hershey Medical CenterTeresa De Marco, MD, Principal investigator, University of California San Francisco Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387803
- Sponsor's protocol ID
- Clinicals0010
- Status last verified
- Jan 2007
- First submitted
- 11 Oct 2006
- Last updated
- 25 Jan 2007
- Results posted
- No
Publications
Higgins SL, Hummel JD, Niazi IK, Giudici MC, Worley SJ, Saxon LA, Boehmer JP, Higginbotham MB, De Marco T, Foster E, Yong PG. Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias. J Am Coll Cardiol. 2003 Oct 15;42(8):1454-9. doi: 10.1016/s0735-1097(03)01042-8.
PubMed 14563591
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VENTAK CHF/CONTAK CD Biventricular Pacing Study
- ClinicalTrials.gov ID
- NCT00387803
- Acronym / sponsor ID
- Clinicals0010
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 581 participants
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 1998
- Study completion
- Aug 2001
- First posted
- 13 Oct 2006 (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 was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.
Detailed description
Patients enrolled received a device with cardiac resynchronization therapy (CRT) and defibrillation. Patients were randomized to CRT on or off for up to six months and evaluated for mortality, hospitalization, and functional outcomes including exercise capacity, quality of life, symptomatic status, and echocardiographic analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic heart failure
- Left ventricular ejection fraction <= 35%
- QRS width >= 120 ms
- Indicated for an implantable cardioverter defibrillator
Key exclusion criteria (2 listed)
- Indicated for a pacemaker
- Atrial tachyarrhythmias
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 with Defibrillation | Device | – |
Primary outcome
Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia
5 secondary outcomes
Peak VO2
NYHA Class
Six minute walk distance
Quality of life
Echocardiographic measures
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 25 Jan 2007.
- Results publication: PubMed 14563591Higgins SL, Hummel JD, Niazi IK, Giudici MC, Worley SJ, Saxon LA, Boehmer JP, Higginbotham MB, De Marco T, Foster E, Yong PG. Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias. J Am Coll Cardiol. 2003 Oct 15;42(8):1454-9. doi: 10.1016/s0735-1097(03)01042-8.
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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.
Steven Higgins, MD principal investigator
Scripps Memorial Hospital
Leslie A Saxon, MD principal investigator
University of California San Francisco Medical Center
John Boehmer, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cardiac Resynchronization Therapy with Defibrillation in people with Heart Failure, Congestive and Ventricular Fibrillation, run by Boston Scientific Corporation at 1 site in United States.
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 4 inclusion and 2 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 25 Jan 2007. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia. 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 NCT00387803, 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 25 Jan 2007.