Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543446
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy in Contemporary Heart Failure Patients With a Low Risk for Arrhythmic Death
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONTEMP-ICD
Brief Summary:
The investigators aim to compare the risk of mortality of Non-implantable carioverter defibrillator ICD vs ICD management in patients with heart failure with reduced ejection fraction HFrEF
Detailed Description:
The proposed CONTEMP-ICD trial is a prospective multicenter open-label randomized controlled trial enrolling 3290 participants with HFrEF on stable and optimal guideline-directed medical therapy GDMT who are eligible for a primary prevention ICD but have a low predicted arrhythmic risk Enrolled participants will be randomized in a 11 ratio to non-ICD vs ICD treatment arms The investigators hypothesize that in participants with HFrEF who have a low predicted arrhythmic risk non-ICD vs ICD is non-inferior with respect to the primary endpoint of all-cause mortality and superior survival free of major cardiovascular CV events
This study will recruit adults 18 years of age and older with heart failure Participants will be asked to complete questionnaires Information from medical records will be gathered including medical history physical exam medications blood work results and imaging Visits will be at initial three six months and every six months beyond six months For those who get an ICD device an interrogation will be collected at the visits
This study will recruit adults 18 years of age and older with heart failure Participants will be asked to complete questionnaires Information from medical records will be gathered including medical history physical exam medications blood work results and imaging Visits will be at initial three six months and every six months beyond six months For those who get an ICD device an interrogation will be collected at the visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None