INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs

Tachycardia Clinical Trial

Official title:

Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148967
• Other study ID #: CR-CA-051403-T
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: November 20, 2006
• Start date: July 2003
• Est. completion date: October 2005

Study information

• Verified date: November 2006
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

INTRINSIC RV is a two-armed randomized trial that will compare the effects of innovative dual-chamber pacing with AV Search Hysteresis to standard VVI among ICD patients.

Description:

The purpose of study is to assess whether AVSH will provide benefits of a dual-chamber ICD without the deleterious effects of unnecessary RV pacing. This study will aim to demonstrate that DDDR-AVSH is equal to VVI with respect to mortality and HF hospitalizations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1535
• Est. completion date: October 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who meet VITALITY™AVT® ICD indications

• Patients who sign and date a Patient Informed Consent prior to device implant

• Patients who remain in the clinical care of the enrolling physician

Exclusion Criteria:

• Patients with current indication for CRT-D

• Patients who previously had a pacemaker, ICD or CRT-D

• Patients with chronic AF

• Patients whose life expectancy is <12 months due to other medical conditions

• Patients who are expected to receive a heart transplant during the duration of the study

• Patients with epicardial pacing leads

• Patients who have CABG, PCI, cardiac or other arrhythmia surgery planned but not yet performed

• Patients with or who are likely to receive a tricuspid or other valve prosthesis

• Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study

• Patients who are younger than 18 years of age

• Patients who are pregnant

• Patients who are mentally incompetent and cannot give Patient Informed Consent or participate in the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachycardia

Intervention

Device:
• Implantable Cardioverter Defibrillator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate that DDDR-AVSH is as effective as VVI with respect to the composite endpoint of death or heart failure hospitalizations.
Secondary	The following variables will be compared between patients who are randomized to either DDDR-AVSH or VVI:
Secondary	The prevalence of atrial fibrillation, Changes in medication dosage, including beta-blocker, anti-arrhythmic and coumadin medications, Programming changes, Quality of life