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Heart FailurePhase 3NCT00158977

CONTAK RENEWAL 3 AVT

A Phase 3 study testing CONTAK RENEWAL 3 AVT in people with Heart Failure and Atrial Fibrillation, run by Boston Scientific Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The RENEWAL 3 AVT device is designed to treat patients suffering from HF, with a history of or at risk of developing atrial and ventricular arrhythmias Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Atrial Fibrillation
What is being tested?
CONTAK RENEWAL 3 AVT
Type of treatment
Medical device
How many people
73 participants
Where
1 siteUnited States
Study dates
Nov 2003to Feb 2008
Phase
Phase 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

  • Patients who meet the following criteria should be given consideration for inclusion in the clinical investigation:
  • Meet all device indications and contraindications
  • Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol
  • Prescribed to stable optimal pharmacologic therapy for heart failure
  • Creatinine < 2.5 mg/dL obtained no more than two weeks prior to enrollment
  • Age 18 or above, or of legal age to give informed consent specific to state and national law
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  • Geographically stable residents who are available for follow-up
  • 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

  • Patients who will be excluded from the investigation are those who meet any one of the following criteria:
  • Have a preexisting non-Guidant left ventricular lead
  • Have a preexisting unipolar pacemaker that will not be explanted/abandoned
  • Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
  • 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
  • Have a known hypersensitivity to a 0.7 mg dose of dexamethasone acetate
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  • Have surgically uncorrected primary valvular heart disease
  • Currently requiring hemo-dialysis
  • Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment
  • Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
  • Have a mechanical tricuspid heart valve
  • Enrolled in any concurrent study, without Guidant written approval, that may confound the results of this study
  • 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 ³ 48 hours in duration and was not anticoagulated at an adequate therapeutic level for the 4 weeks prior to enrollment with an INR = 2.0-3.0 at enrollment
  • Women who are pregnant or plan to become pregnant
  • Note: Women of childbearing potential must have a negative pregnancy test within 7 days of enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Multiple locations in the US

    Saint Paul, Minnesota, 55112

Other trials in United States

About this study

Official title: CONTAK RENEWAL 3 AVT Study

The RENEWAL 3 AVT device is designed to treat patients suffering from HF, with a history of or at risk of developing atrial and ventricular arrhythmias

Read the detailed description

A clinical evaluation to:

  • Confirm that there are no adverse interactions when Ventricular Tachyarrhythmia (ICD), Heart Failure (HF) and Atrial Tachyarrhythmia (AT) therapies are combined
  • Confirm Cardiac Resynchronization Therapy (CRT) and Ventricular Tachyarrhythmia (ICD) therapy is delivered in the presence of atrial therapies
  • Demonstrate the safety and effectiveness of atrial therapies in a heart failure population
Being tested
CONTAK RENEWAL 3 AVT
Keywords
heart failure, atrial fibrillation, cardiac resynchronization therapy defibrillator
Medical subject headings
Heart Failure, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CONTAK RENEWAL 3 AVTDevice

    CONTAK RENEWAL 3 AVT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Endpoint: To show that the RENEWAL 3 AVT system functions safely at 3 months

    Measured: 3 months

  2. Effectiveness Endpoint: To demonstrate the effective termination of induced episodes of atrial fibrillation by cardioversion

    Measured: 3 months

  3. Effectiveness Endpoint: To correctly detect and classify atrial arrhythmias (AF and/or SVT) from all other rhythms

    Measured: 3 months

Secondary outcomes (4)

  1. Safety Endpoint: Ventricular Fibrillation (VF) Detection Time

    Measured: 3 months

  2. Safety Endpoint: Percent BiV Pacing

    Measured: 3 months

  3. Safety Endpoint: EASYTRAK 2 Lead Complication-Free Rate

    Measured: 3 months

  4. Safety Endpoint: Rate of Inappropriate Response to BiV Trigger Feature

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startNov 2003
  3. Primary completionOct 2004
  4. Study completionFeb 2008

Resources

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00158977
Sponsor's protocol ID
Clinicals0008
Status last verified
Sep 2011
First submitted
8 Sep 2005
Last updated
29 Sep 2011
Results posted
No

Publications

  • Saxon LA, Greenfield RA, Crandall BG, Nydegger CC, Orlov M, VAN Genderen R. Results of the multicenter RENEWAL 3 AVT clinical study of cardiac resynchronization defibrillator therapy in patients with paroxysmal atrial fibrillation. J Cardiovasc Electrophysiol. 2006 May;17(5):520-5. doi: 10.1111/j.1540-8167.2006.00440.x.

    PubMed 16684026

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CONTAK RENEWAL 3 AVT in people with Heart Failure and Atrial 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 9 inclusion and 16 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 29 Sep 2011. 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 phase mean?

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?

Safety Endpoint: To show that the RENEWAL 3 AVT system functions safely at 3 months (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT00158977, 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 29 Sep 2011.

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CONTAK RENEWAL 3 AVT (NCT00158977) | AzTrials