NCT00158977

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P25-P50 for phase_3 heart-failure

Timeline
Completed

Started Nov 2003

Typical duration for phase_3 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

September 29, 2011

Status Verified

September 1, 2011

Enrollment Period

11 months

First QC Date

September 8, 2005

Last Update Submit

September 28, 2011

Conditions

Heart FailureAtrial Fibrillation

Keywords

heart failureatrial fibrillationcardiac resynchronization therapy defibrillator

Outcome Measures

Primary Outcomes (3)

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

    3 months

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

    3 months

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

    3 months

Secondary Outcomes (4)

  • Safety Endpoint: Ventricular Fibrillation (VF) Detection Time

    3 months

  • Safety Endpoint: Percent BiV Pacing

    3 months

  • Safety Endpoint: EASYTRAK 2 Lead Complication-Free Rate

    3 months

  • Safety Endpoint: Rate of Inappropriate Response to BiV Trigger Feature

    3 months

Interventions

CONTAK RENEWAL 3 AVTDEVICE

CONTAK RENEWAL 3 AVT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple locations in the US

Saint Paul, Minnesota, 55112, United States

Location

Related Publications (1)

  • 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.

    PMID: 16684026RESULT

MeSH Terms

Conditions

Heart FailureAtrial Fibrillation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

November 1, 2003

Primary Completion

October 1, 2004

Study Completion

February 1, 2008

Last Updated

September 29, 2011

Record last verified: 2011-09

Locations

US(1)