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CONTAK RENEWAL 3 AVT

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Boston Scientific

Status and phase

Completed
Phase 3

Conditions

Atrial Fibrillation
Heart Failure

Treatments

Device: CONTAK RENEWAL 3 AVT

Study type

Interventional

Funder types

Industry

Identifiers

NCT00158977
Clinicals0008

Details and patient eligibility

About

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

Full 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

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
  • 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.

Exclusion criteria

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
  • 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 design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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