Optimal Medical therapy plus ICD for Congestive Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Congestive Heart Failure+2 MoreOptimal Medical therapy plus CRT/ICD - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether adding pacing to both ventricles is of benefit in heart failure patients with a permanent irregular heart rhythm (atrial fibrillation).

Eligible Conditions
  • Congestive Heart Failure
  • Cardiovascular Disease
  • Atrial Fibrillation

Treatment Effectiveness

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Baseline to a minimum of 18 months

Month 18
6 Minute walk distance
Perinatal death
Cardiovascular hospitalizations
Cardiovascular mortality
Composite of all-cause mortality and heart failure
Cost-effectiveness
Hospitalization for Heart Failure
Quality of Life Questionnaire
The is a reduction of Left Ventricular End Systolic Volume index (LVESVi)

Trial Safety

Trial Design

2 Treatment Groups

Optimal Medical therapy plus ICD
1 of 2
Optimal Medical therapy plus CRT/ICD
1 of 2

Active Control

200 Total Participants · 2 Treatment Groups

Primary Treatment: Optimal Medical therapy plus ICD · No Placebo Group · N/A

Optimal Medical therapy plus ICD
Device
ActiveComparator Group · 1 Intervention: Optimal Medical therapy plus ICD · Intervention Types: Device
Optimal Medical therapy plus CRT/ICD
Device
ActiveComparator Group · 1 Intervention: Optimal Medical therapy plus CRT/ICD · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to a minimum of 18 months

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
179 Previous Clinical Trials
87,672 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,232 Previous Clinical Trials
24,675,452 Total Patients Enrolled
Anthony SL Tang, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
in patients with or without structural heart disease The aim of this study is to determine the feasibility and safety of an implantable cardioverter-defibrillator (ICD) for primary or secondary prevention of sudden cardiac death (SCD) in patients with or without structural heart disease.
in patients with symptomatic HF and left ventricular dysfunction (EF ≤35%) The best possible medical treatment for heart failure lasting three or more months should be used in patients who are symptomatic and have a left ventricular dysfunction of 35% or less.
The patient has a low left ventricular ejection fraction (LVEF) of less than 35%
Patients who have had heart failure symptoms in the last 3 months and are classified as having either NYHA Class II or III symptoms will be included in the study.