NCT00148967

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,535

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2003

Typical duration for phase_4

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

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

November 22, 2006

Status Verified

November 1, 2006

First QC Date

September 7, 2005

Last Update Submit

November 20, 2006

Conditions

Tachycardia

Keywords

right ventricular pacingimplantable cardioverter defibrillator

Outcome Measures

Primary Outcomes (1)

  • Demonstrate that DDDR-AVSH is as effective as VVI with respect to the composite endpoint of death or heart failure hospitalizations.

Secondary Outcomes (2)

  • The following variables will be compared between patients who are randomized to either DDDR-AVSH or VVI:

  • The prevalence of atrial fibrillation, Changes in medication dosage, including beta-blocker, anti-arrhythmic and coumadin medications, Programming changes, Quality of life

Interventions

Implantable Cardioverter DefibrillatorDEVICE

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Sullivan RM, Russo AM, Berg KC, Stolen KQ, Seth M, Perschbacher D, Day JD, Olshansky B. Arrhythmia rate distribution and tachyarrhythmia therapy in an ICD population: results from the INTRINSIC RV trial. Heart Rhythm. 2012 Mar;9(3):351-8. doi: 10.1016/j.hrthm.2011.10.018. Epub 2011 Oct 19.

    PMID: 22016074DERIVED

  • Ahmadi-Kashani M, Kessler DJ, Day J, Bunch TJ, Stolen KQ, Brown S, Sbaity S, Olshansky B; INTRINSIC RV Study Investigators. Heart rate predicts outcomes in an implantable cardioverter-defibrillator population. Circulation. 2009 Nov 24;120(21):2040-5. doi: 10.1161/CIRCULATIONAHA.108.847608. Epub 2009 Nov 9.

    PMID: 19901194DERIVED

  • Bunch TJ, Day JD, Olshansky B, Stolen KQ, Mullin CM; INTRINSIC RV Study Investigators. Newly detected atrial fibrillation in patients with an implantable cardioverter-defibrillator is a strong risk marker of increased mortality. Heart Rhythm. 2009 Jan;6(1):2-8. doi: 10.1016/j.hrthm.2008.09.025. Epub 2008 Sep 27.

    PMID: 18996055DERIVED

MeSH Terms

Conditions

Tachycardia

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Officials

  • Brian Olshansky, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

  • John Day, MD

    Utah Heart Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

July 1, 2003

Study Completion

October 1, 2005

Last Updated

November 22, 2006

Record last verified: 2006-11