Heart FailurePhase 2/3NCT00180336
Safety and Efficacy Study of RENEWAL 4 AVT
A Phase 2/3 study testing CRT-D in people with Heart Failure and Tachycardia, run by Boston Scientific Corporation at 1 site in Germany.
Trial summary
The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Tachycardia, Atrial Fibrillation
- What is being tested?
- CRT-D
- Type of treatment
- Medical device
- How many people
- 170 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2004to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indications for the device
- Availability for follow-up at an approved Field Following center, at the protocol defined intervals
- Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
- Prescribed to stable optimal pharmacologic therapy for HF
- Age 18 or above, or of legal age to give informed consent specific to national law
- Able to provide documented evidence of one or more episodes of AF/AT within 12 months of implantation NOTE: Guidant recommends anticoagulation therapy per physician discretion.
Who cannot join
- Right bundle branch block morphology
- Life expectancy of less than six months due to other medical conditions
- Expectation of a heart transplant during the period of the study
- Patients with or who are likely to receive a mechanical tricuspid valve during the course of the study
- Have a preexisting unipolar pacemaker that will not be explanted/abandoned
- Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) within 180 days prior to enrollment
Show all 11Show fewer
- Have a known hypersensitivity to dexamethasone acetate
- Enrolled in any other study, including drug investigation
- Women that are pregnant or planning to become pregnant
- A Cerebral Vascular Event/ Transient Ischemic Attack within 12 months of implantation
- During the four weeks prior to implantation, a patient experiences an episode of AF >= 48 hours in duration and was not anticoagulated for at an adequate therapeutic level (INR >= 2.0) for the 4 weeks prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CONTAK RENEWAL 4 AVT Field Following
The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device.
Read the detailed description
This is a prospective, two-arm, non-randomized, multi-center European field following, designed to demonstrate the safety and effectiveness of the CONTAK RENEWAL 4 AVT device in humans.
- Being tested
- CRT-D
- Keywords
- Heart Failure, Tachycardia, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation
- Medical subject headings
- Heart Failure, Tachycardia, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-DDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
System Complication-Free Rate at 6 months
Effectiveness of LV Only/LV Offset at 6 months
Secondary outcomes (4)
LVESD at 6 months
Six-minute walk at 6 months
NYHA at 6 months
QOL at 6 months
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 startJul 2004
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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johannes Sperzel, MD, Principal investigator, Kerckhoff Klinik Bad Nauheim (Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180336
- Sponsor's protocol ID
- Clinicals0004
- Status last verified
- Jun 2007
- First submitted
- 12 Sep 2005
- Last updated
- 25 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONTAK RENEWAL 4 AVT Field Following
- ClinicalTrials.gov ID
- NCT00180336
- Acronym / sponsor ID
- Clinicals0004
- Keywords
- Heart Failure, Tachycardia, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- 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 assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device.
Detailed description
This is a prospective, two-arm, non-randomized, multi-center European field following, designed to demonstrate the safety and effectiveness of the CONTAK RENEWAL 4 AVT device in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Indications for the device
- Availability for follow-up at an approved Field Following center, at the protocol defined intervals
- Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
- Prescribed to stable optimal pharmacologic therapy for HF
- Age 18 or above, or of legal age to give informed consent specific to national law
Key exclusion criteria (11 listed)
- Right bundle branch block morphology
- Life expectancy of less than six months due to other medical conditions
- Expectation of a heart transplant during the period of the study
- Patients with or who are likely to receive a mechanical tricuspid valve during the course of the study
- Have a preexisting unipolar pacemaker that will not be explanted/abandoned
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 |
|---|---|---|
| CRT-D | Device | – |
Primary outcome
System Complication-Free Rate at 6 months
Effectiveness of LV Only/LV Offset at 6 months
4 secondary outcomes
LVESD at 6 months
Six-minute walk at 6 months
NYHA at 6 months
QOL at 6 months
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 Jun 2007.
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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.
Johannes Sperzel, MD principal investigator
Kerckhoff Klinik Bad Nauheim (Germany)
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 CRT-D in people with Heart Failure and Tachycardia, run by Boston Scientific Corporation at 1 site in Germany.
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 6 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 25 Jun 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 Germany. 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?
System Complication-Free Rate at 6 months. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 25 Jun 2007.