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

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Boston Scientific

Status and phase

Completed
Phase 4

Conditions

Tachycardia

Treatments

Device: Implantable Cardioverter Defibrillator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00148967
CR-CA-051403-T

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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