Heart Failure With Reduced Ejection FractionCONTEMP-ICDNCT06543446
Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy
A study testing ICD implantation in people with Heart Failure With Reduced Ejection Fraction, run by University of Rochester at 15 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- ICD implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,290 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 4 Mar 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years (no upper limit)
- Class I or IIa indication for a primary prevention ICD15: Ischemic or non-ischemic cardiomyopathy and NYHA Class ≥ II if most recent LVEF is ≤ 35% OR ischemic cardiomyopathy with NYHA Class I if most recent LVEF is ≤ 30%
- Most recent LVEF (%) obtained per cardiac imaging obtained at any time prior to enrollment after being stable on optimal GDMT** for at least one month
- Stable optimal GDMT at least one calendar month prior to last cardiac imaging test, prespecified as one of the following for at least 1 calendar month prior to study randomization:
- receiving all 4 therapy classes (beta-blockers, ARNI/ARB/ACE, MRA and SGLT2i) OR GDMT Score ≥ 6 (per Figure 7)
- MADIT-ICD Benefit Score < 50 (per Figure 4)
Who cannot join
- Existing ICD/CRT-D
- • Planned CRT-P or CRT-D implant for any indications including Class I or IIa indication for CRT: Presence of left bundle branch block (LBBB) with QRS ≥ 120 msec OR QRS duration ≥ 150 msec regardless of QRS morphology OR decision for CRT implant by EP provider for other indications
- Acute MI within the past 3 calendar months
- Chronic renal failure requiring hemodialysis
- Coronary revascularization within the past 3 calendar months
- History of sustained VT or VF
Show all 10Show fewer
- Known genetic cause of cardiomyopathy
- Life expectancy < 1 year
- Unable or unwilling to follow study protocol
- Inability to consent
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States13 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Tufts Medical Center
Boston, Massachusetts, 02111
University of Virginia Health System
Charlottesville, Virginia, 22902
Corewell Health
Grand Rapids, Michigan, 49503
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
West Virginia University
Morgantown, West Virginia, 26506
Rutgers
New Brunswick, New Jersey, 08901
Northwell Health
New York, New York, 10075
The Valley Hospital
Paramus, New Jersey, 07652
MaineHealth
Portland, Maine, 04102
Nuvance Health Hudson Valley Cardiovascular Practice, PC
Poughkeepsie, New York, 12601
University of Rochester
Rochester, New York, 14642
Intermountain Health Care, Inc.
Salt Lake City, Utah, 84111
Canada2 sites
University of Calgary
Calgary, Alberta, T2N4Z6
University of Alberta
Edmonton, Alberta, T6G 2B7
About this study
Official title: Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy in Contemporary Heart Failure Patients With a Low Risk for Arrhythmic Death
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).
Read the 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 1:1 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.
- Being tested
- ICD implantation
- Keywords
- Implantable cardioverter defibrillator, Sudden cardiac death, guideline directed medical therapy
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD implantationProcedure or surgery
Surgical implant of ICD device
| Study group | Role | What they receive |
|---|---|---|
| No-ICD implantation | No intervention | No-ICD implantation despite current recommendation |
| ICD implantation | Active comparator | ICD implantation based on current guidelines Receives: Procedure: ICD implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Death from any cause
Measured: through study completion, an average of 3.5 year
Secondary outcomes (4)
Major adverse cardiovascular events
First occurrence of hospitalization for one of the following: stroke, myocardiac infarction, device-related complications, ICD shocks.
Measured: through study completion, an average of 3.5 years
Healthcare utilization
Total number of the following events during following: all-cause hospital admissions, emergency department visits, planned and unplanned clinic visits. All events will be captured from electronic medical records
Measured: through study completion, an average of 3.5 year
Quality of life, using the Kansas City Cardiomyopathy Questionnaire [KCCQ] and EuroQol-5 Dimension (EQ-5D)
Kansas City Cardiomyopathy Questionnaire [KCCQ] (the KCCQ ranges from 0 to 100, with 0 representing the worst possible health status and 100) and EuroQol-5 Dimension (EQ-5D) (Range from -0.59 to 1, with 1 representing the best possible health state and an index value of less than 0 representing the worst possible health state)
Measured: One year
Quality of life, using the EuroQol-5 Dimension (EQ-5D)
Range from -0.59 to 1, with 1 representing the best possible health state and an index value of less than 0 representing the worst possible health state
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start4 Mar 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Why it stopped: Low enrollment during the feasibility phase
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3,290 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Ilan Goldenberg, University of Rochester
- Investigators
- Ilan Goldenberg, MD, Principal investigator, Univ of Rochester Medical Center, Clinical Cardiovascular Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543446
- Sponsor's protocol ID
- ADVARRA
- Acronym
- CONTEMP-ICD
- Status last verified
- May 2026
- First submitted
- 25 Jul 2024
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fiuzat M, Hamo CE, Butler J, Abraham WT, DeFilippis EM, Fonarow GC, Lindenfeld J, Mentz RJ, Psotka MA, Solomon SD, Teerlink JR, Vaduganathan M, Vardeny O, McMurray JJV, O'Connor CM. Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 Feb 8;79(5):504-510. doi: 10.1016/j.jacc.2021.11.033.
PubMed 35115106Goldenberg I, Zareba W, Ezekowitz JA, Albert C, Alexis JD, Anderson L, Behr ER, Daubert J, Di Palo KE, Ellenbogen KA, Dzikowicz DJ, Harrington JM, Hsich E, Huang DT, Januzzi JL, Jawaid A, Kutyifa V, Lala-Trindade A, Nakonechnyi A, Onwuanyi A, Pina IL, Sandhu RK, Sears S, Sroubek J, Baykaner T, Strawderman R, Beck C, Butler J. Rationale and design of the comparative effectiveness of ICD vs non-ICD therapy in contemporary heart failure patients at a low risk for arrhythmic death (CONTEMP-ICD) trial. Am Heart J. 2026 Jan;291:162-174. doi: 10.1016/j.ahj.2025.08.020. Epub 2025 Sep 4.
PubMed 40914445
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy in Contemporary Heart Failure Patients With a Low Risk for Arrhythmic Death
- ClinicalTrials.gov ID
- NCT06543446
- Acronym / sponsor ID
- CONTEMP-ICD / ADVARRA
- Keywords
- Implantable cardioverter defibrillator, Sudden cardiac death, guideline directed medical therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment during the feasibility phase
- Enrolment
- 3,290 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 1:1 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-ICD implantation | No intervention | –No-ICD implantation despite current recommendation |
| ICD implantation | Active comparator | Procedure: ICD implantationICD implantation based on current guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years (no upper limit)
- Class I or IIa indication for a primary prevention ICD15: Ischemic or non-ischemic cardiomyopathy and NYHA Class ≥ II if most recent LVEF is ≤ 35% OR ischemic cardiomyopathy with NYHA Class I if most recent LVEF is ≤ 30%
- Most recent LVEF (%) obtained per cardiac imaging obtained at any time prior to enrollment after being stable on optimal GDMT** for at least one month
- Stable optimal GDMT at least one calendar month prior to last cardiac imaging test, prespecified as one of the following for at least 1 calendar month prior to study randomization:
- receiving all 4 therapy classes (beta-blockers, ARNI/ARB/ACE, MRA and SGLT2i) OR GDMT Score ≥ 6 (per Figure 7)
Key exclusion criteria (10 listed)
- Existing ICD/CRT-D
- • Planned CRT-P or CRT-D implant for any indications including Class I or IIa indication for CRT: Presence of left bundle branch block (LBBB) with QRS ≥ 120 msec OR QRS duration ≥ 150 msec regardless of QRS morphology OR decision for CRT implant by EP provider for other indications
- Acute MI within the past 3 calendar months
- Chronic renal failure requiring hemodialysis
- Coronary revascularization within the past 3 calendar months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD implantationSurgical implant of ICD device | Procedure or surgery | ICD implantation |
Primary outcome
All-cause mortality
Time frame: through study completion, an average of 3.5 year
Death from any cause
4 secondary outcomes
Major adverse cardiovascular events
Time frame: through study completion, an average of 3.5 years
Healthcare utilization
Time frame: through study completion, an average of 3.5 year
Quality of life, using the Kansas City Cardiomyopathy Questionnaire [KCCQ] and EuroQol-5 Dimension (EQ-5D)
Time frame: One year
Quality of life, using the EuroQol-5 Dimension (EQ-5D)
Time frame: One year
Results and safety
The study was stopped early (reason given: Low enrollment during the feasibility phase). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 35115106Fiuzat M, Hamo CE, Butler J, Abraham WT, DeFilippis EM, Fonarow GC, Lindenfeld J, Mentz RJ, Psotka MA, Solomon SD, Teerlink JR, Vaduganathan M, Vardeny O, McMurray JJV, O'Connor CM. Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 Feb 8;79(5):504-510. doi: 10.1016/j.jacc.2021.11.033.
- Derived from this study: PubMed 40914445Goldenberg I, Zareba W, Ezekowitz JA, Albert C, Alexis JD, Anderson L, Behr ER, Daubert J, Di Palo KE, Ellenbogen KA, Dzikowicz DJ, Harrington JM, Hsich E, Huang DT, Januzzi JL, Jawaid A, Kutyifa V, Lala-Trindade A, Nakonechnyi A, Onwuanyi A, Pina IL, Sandhu RK, Sears S, Sroubek J, Baykaner T, Strawderman R, Beck C, Butler J. Rationale and design of the comparative effectiveness of ICD vs non-ICD therapy in contemporary heart failure patients at a low risk for arrhythmic death (CONTEMP-ICD) trial. Am Heart J. 2026 Jan;291:162-174. doi: 10.1016/j.ahj.2025.08.020. Epub 2025 Sep 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilan Goldenberg, MD principal investigator
Univ of Rochester Medical Center, Clinical Cardiovascular Research Center
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICD implantation in people with Heart Failure With Reduced Ejection Fraction, run by University of Rochester at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment during the feasibility phase). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: through study completion, an average of 3.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06543446, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.