Safety and Efficacy Study of RENEWAL 4 AVT

NCT00180336 | Completed Phase 2

• 1 other identifier: Clinicals0004
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device.

Conditions

Heart Failure; Tachycardia; Atrial Fibrillation; Atrial Flutter; Ventricular Fibrillation

Keywords

Heart Failure; Tachycardia; Atrial Fibrillation; Atrial Flutter; Ventricular Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

CRT-D DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Kerckhof Klinik

Bad Nauheim, 61231, Germany

Location

MeSH Terms

Conditions

Heart Failure; Tachycardia; Atrial Fibrillation; Atrial Flutter; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johannes Sperzel, MD

  Kerckhoff Klinik Bad Nauheim (Germany)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: July 1, 2004
• Last Updated: June 25, 2007

Record last verified: 2007-06

Locations

DE (1)