Status:
COMPLETED
INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Tachycardia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Detailed 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
1535 Patients enrolled
Trial Details
Trial ID
NCT00148967
Start Date
July 1 2003
End Date
October 1 2005
Last Update
November 22 2006
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