Ischemic CardiomyopathyREVIVE-HFNCT03845127

Randomized Evaluation and Verification of Ventricular Enhancement

A study testing Revivent TC Ventricular Enhancement System and GDMT in people with Ischemic Cardiomyopathy and Heart Failure, run by BioVentrix at 1 site in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

A prospective, multi-center, dual-arm randomized controlled study comparing treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC System plus Guideline Directed Medical Therapy (GDMT) compared to GDMT alone. Read more about this study

Who is it for?: Any age
Conditions the study is for: Ischemic Cardiomyopathy, Heart Failure
What is being tested?: Revivent TC Ventricular Enhancement System and GDMT
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteGermany
Study dates: 1 Jan 2020to 31 Dec 2024
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients suffering from heart failure symptoms with cardiac dysfunction caused by a previous myocardial infarction resulting in increased LV systolic volume and in a discrete, contiguous, acontractile, (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) region of the left ventricle.

Who cannot join

Calcified ventricular wall in the area of intended scar exclusion as verified by one or more appropriate imaging modalities;
Inadequate myocardial viability in regions remote from the scar.
Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by echocardiography or equivalent that has not been adequately treated with weeks of anticoagulant at therapeutic levels;
Cardiac Resynchronization Therapy (CRT) consisting of Bi-ventricular pacemaker device (i.e., not ICD only) placement ≤ 60 days prior to treatment;
Patient intolerance or unwillingness to take anti-coagulation medication;
Functioning pacemaker leads in antero-apical RV, which, in the opinion of the investigator, would interfere with anchor placement;

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Pulmonary Arterial Pressure > 60 mm Hg shown by right heart catheterization to be precapillary or unresponsive to vasodilator therapy;
Myocardial Infarction within 90 days prior to the procedure;
Previous right neck surgery, previous pericardiotomy, previous left chest surgery that precludes device placement;
Chronic renal failure with a serum creatinine >2 mg/dL;
Inoperable coronary disease with significant ischemia or pulmonary disease that would preclude transient single lung ventilation.
Baseline 6-minute walk distance of >450m

Trial locations and contacts

1 site in 1 country.

Germany1 site

German Heart Institute Berlin and Charité University Medicine Berlin
Berlin, 13353

Other trials in Germany

About this study

Official title: Randomized Evaluation and Verification of Ventricular Enhancement: The REVIVE-HF Study

Read the detailed description

The purpose of the study is to demonstrate that treatment with the BioVentrix Revivent TC System is more effective than guideline directed medical therapy for the treatment of ischemic heart failure. This is a prospective, multi-center, dual-arm randomized controlled study comparing treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC System plus Guideline Directed Medical Therapy (GDMT) compared to GDMT alone. This study will include 180 patients of which 120 patients will be treated with the investigational device and 60 patients will be maintained on GDMT.

Conditions: Ischemic Cardiomyopathy, Heart Failure
Being tested: Revivent TC Ventricular Enhancement System, GDMT
Keywords: Ischemic Cardiomyopathy, Heart Failure, Revivent TC System
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Revivent TC Ventricular Enhancement SystemDevice
Anchors that are implanted into the left ventricle to reshape and reduce the size and increase the efficiency of the pumping chamber.
GDMTDrug
Guideline Directed Medical Therapy

Study groups in NCT03845127
Study group	Role	What they receive
Revivent TC Ventricular Enhancement System plus GDMT	Experimental	Patients will receive treatment with the Revivent TC Ventricular Enhancement System while being maintained on Guideline Directed Medical Therapy for treatment of Heart Failure. Receives: Device: Revivent TC Ventricular Enhancement System; Drug: GDMT
GDMT Only	Active comparator	Patients will be maintained on Guideline Directed Medical Therapy for treatment of Heart Failure. Receives: Drug: GDMT

What is being measured

The primary outcome is the main question the study is designed to answer.

6 Minute Walking Distance
Improvement of heart failure symptoms compared to baseline as measured by changes in 6 Minute Walking Distance.
Measured: 3 and 6 months after enrollment

Secondary outcomes (4)

Quality of Life Index
Changes in Quality of Life Index measured compared to baseline using the MLHFQ Quality of Life Questionnaire.
Measured: 3 and 6 months after enrollment
NYHA Classification
Changes in NYHA Heart Classification compared to baseline
Measured: 3 and 6 months after enrollment
LVESVI and LVEDVI
Changes in left ventricular end systolic volume index (LVESVI) end diastolic volume index (LVEDVI) measured by echocardiogram compared to baseline
Measured: 3 and 6 months after enrollment
LVEF
Changes in left ventricular ejection fraction (LVEF) measured by echocardiogram compared to baseline
Measured: 3 and 6 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202031 Dec 2024

First posted19 Feb 2019
Study start1 Jan 2020
Primary completion31 Dec 2024
Study completion31 Dec 2024

Why it stopped: Lack of enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ischemic CardiomyopathyStudies 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
Model description: 2:1 Randomized Study Design. Crossover permitted after 6 months.
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03845127
Sponsor's protocol ID: CIP-0080
Acronym: REVIVE-HF
Status last verified: Apr 2025
First submitted: 15 Feb 2019
Last updated: 10 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY
Myocardial Infarction (MI), Sudden Cardiac Death Due to Cardiac Arrhythmia
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MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall

All Ischemic Cardiomyopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Evaluation and Verification of Ventricular Enhancement: The REVIVE-HF Study
ClinicalTrials.gov ID: NCT03845127
Acronym / sponsor ID: REVIVE-HF / CIP-0080
Conditions: Ischemic Cardiomyopathy, Heart Failure
Keywords: Ischemic Cardiomyopathy, Heart Failure, Revivent TC System
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Lack of enrollment
Enrolment: 0 participants (actual)
Lead sponsor: BioVentrixIndustry (pharma, biotech, devices)
Study start: 1 Jan 2020 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 19 Feb 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 2:1 Randomized Study Design. Crossover permitted after 6 months.

Arm	Type	Receives
Revivent TC Ventricular Enhancement System plus GDMT	Experimental	Device: Revivent TC Ventricular Enhancement System, Drug: GDMTPatients will receive treatment with the Revivent TC Ventricular Enhancement System while being maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.
GDMT Only	Active comparator	Drug: GDMTPatients will be maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Patients suffering from heart failure symptoms with cardiac dysfunction caused by a previous myocardial infarction resulting in increased LV systolic volume and in a discrete, contiguous, acontractile, (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) region of the left ventricle.

Key exclusion criteria (12 listed)

Calcified ventricular wall in the area of intended scar exclusion as verified by one or more appropriate imaging modalities;
Inadequate myocardial viability in regions remote from the scar.
Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by echocardiography or equivalent that has not been adequately treated with weeks of anticoagulant at therapeutic levels;
Cardiac Resynchronization Therapy (CRT) consisting of Bi-ventricular pacemaker device (i.e., not ICD only) placement ≤ 60 days prior to treatment;
Patient intolerance or unwillingness to take anti-coagulation medication;

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
Revivent TC Ventricular Enhancement SystemAnchors that are implanted into the left ventricle to reshape and reduce the size and increase the efficiency of the pumping chamber.	Device	Revivent TC Ventricular Enhancement System plus GDMT
GDMTGuideline Directed Medical Therapy	Drug	GDMT Only, Revivent TC Ventricular Enhancement System plus GDMT

Primary outcome

6 Minute Walking Distance
Time frame: 3 and 6 months after enrollment
Improvement of heart failure symptoms compared to baseline as measured by changes in 6 Minute Walking Distance.

4 secondary outcomes

Quality of Life Index
Time frame: 3 and 6 months after enrollment
NYHA Classification
Time frame: 3 and 6 months after enrollment
LVESVI and LVEDVI
Time frame: 3 and 6 months after enrollment
LVEF
Time frame: 3 and 6 months after enrollment

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
Individual participant dataSharing planned: No

Related trials for Ischemic Cardiomyopathy

Recruiting
ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY
Myocardial Infarction (MI), Sudden Cardiac Death Due to Cardiac Arrhythmia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall

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.

Stefan Anker, MD principal investigator

Berlin-Brandenburger Centrum für Regenerative Therapien (BCRT) und Medizinische Klinik m. S. Kardiologie

Volkmar Falk, MD principal investigator

Ärztlicher Direktor, Direktor der Klinik für Herz-Thorax-Gefässchirurgie, Deutsches Herzzentrum Berlin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Revivent TC Ventricular Enhancement System and GDMT in people with Ischemic Cardiomyopathy and Heart Failure, run by BioVentrix at 1 site in Germany.

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 1 inclusion and 12 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: withdrawn, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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 withdrawn before enrolling participants, so there are no results.

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?

6 Minute Walking Distance (time frame: 3 and 6 months after enrollment). 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 NCT03845127.

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 10 Apr 2025.