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Heart FailurePhase 1/2RECOVERNCT00881777

Feasibility Study of Radiofrequency Heating of Cardiac Infarction Scar to Treat Heart Failure

A Phase 1/2 study testing Radiofrequency heating of the myocardial infarct scar and Coronary Artery Bypass Grafting (CABG) surgery in people with Heart Failure, run by CoRepair, Inc. at 3 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to examine the safety and potential effectiveness of a new surgical procedure for treating heart failure. The experimental treatment is performed during standard coronary artery bypass graft (CABG) surgery, and applies radiofrequency energy to heat a portion of the damaged heart muscle. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure
What is being tested?
Radiofrequency heating of the myocardial infarct scar and Coronary Artery Bypass Grafting (CABG) surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
3 sitesin 2 countries
Study dates
Sep 2009to Mar 2011
Phase
Phase 1/2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 80 years, inclusive
  • Symptomatic heart failure (defined as persistent NYHA class II or III during the 3 months prior to enrollment)
  • On evidence-based medical therapy for heart failure during the 1 month prior to enrollment
  • Referred for elective coronary artery bypass grafting
  • Dyskinetic transmural myocardial infarct located in the apical portion of the anterior, lateral, and/or inferior left ventricular wall as determined by transthoracic echocardiography ("transmural" means end-diastolic wall thickness of 4 - 6 mm, inclusive)
  • Left ventricular ejection fraction 20 - 45%, inclusive as determined by transthoracic echocardiography
Show all 9Show fewer
  • Left ventricular end-systolic volume index ≥ 60 ml/m2 as determined by transthoracic echocardiography
  • 6-minute walk distance over 150 m
  • Peak VO2 (ml/kg/min): 10.0 - 20.0 for males and 9.0 - 18.0 for females

Who cannot join

  • Myocardial infarction ≤ 3 months prior to enrollment
  • Evidence of calcification within the scar intended to be treated by any imaging modality
  • Presence of a coronary stent within the scar intended to be treated
  • Evidence of left ventricular thrombus
  • Emergent cardiac surgery
  • Percutaneous coronary intervention (PCI) ≤ 1 month prior to enrollment or planned following enrollment
Show all 28Show fewer
  • Only for patients undergoing MR (rather than CT) imaging: Contraindications for MRI (current or anticipated during the 6 months following enrollment), such as pacemaker, Automatic Implantable Cardioverter-Defibrillator (AICD), Cardiac Resynchronization Therapy (CRT) device, central nervous system aneurysm clips, Cochlear implant, or metal shrapnel
  • Only for patients undergoing MR (rather than CT) imaging: Acute or chronic severe renal insufficiency (i.e. a glomerular filtration rate < 30 ml/min/1.73m2) or acute renal insufficiency of any severity due to hepato-renal syndrome
  • Only for patients undergoing MR (rather than CT) imaging: Known allergy or reaction to Gadolinium
  • Atrial fibrillation
  • Prior cardiac surgery (including coronary artery bypass grafting, valve replacement or repair, aortic root replacement) or anticipated during the 6 months following enrollment
  • Major non-cardiac surgery (e.g. knee or hip replacement, laparotomy, carotid endarterectomy, etc.) ≤ 3 months prior to enrollment or planned during the 6 months following enrollment
  • Prior heart, kidney, liver, or lung transplantation
  • Valvular heart disease requiring replacement or repair (e.g. mitral valve regurgitation ≥ 3+)
  • Cardiogenic shock ≤ 72 hours prior to the CABG surgery (defined as need for Intra-Aortic Balloon Pump or requiring intravenous inotropic support)
  • Currently needing (or anticipated need for) Left Ventricular Assist Device or other cardiac replacement device
  • On active heart transplant list or anticipated need for transplant during the 6 months following enrollment
  • Stoke or transient ischemic attack ≤ 3 months prior to enrollment
  • Chronic dialysis
  • Major infection or sepsis ≤ 72 hours of enrollment (defined as requiring IV antibiotics for > 3 days)
  • Endocarditis, myocarditis, or pericarditis
  • Co-morbid condition that, in the investigator's opinion, results in the patient's life expectancy being < 180 days
  • Evidence of significant blood chemistry abnormalities, including creatinine > 2.5 mg/dl, BUN ≥ 100 mg/dl, liver function tests > 3 times upper limit of normal, Hgb < 10 gm/dl, HCT < 25%, platelet count < 100,000/mm3, or white blood cell count < 3,000/mm3 or > 20,000/mm3
  • Females of child-bearing potential without a documented negative pregnancy test within the 14 days prior to enrollment (and prior to the MRI or CT) or who are unwilling to use effective contraception for the duration of this study
  • Participation in another investigational device or drug trial
  • Unable or unwilling to give Informed Consent
  • Unwilling or unlikely to complete the required follow-up
  • Any other medical condition that, in the judgment of the investigator, would cause this study to be detrimental to the patient

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Poland2 sites

  • The Cardinal Stefan Wyszynski Institute of Cardiology

    Warsaw, 04-628

  • Silesian Center for Heart Diseases

    Zabrze, 41-800

Other trials in Poland

Paraguay1 site

  • Sanatorio Italiano

    Asunción

Other trials in Paraguay

About this study

Official title: Radiofrequency Energy Use in Cardiomyopathy and Ventricular Enlargement (RECOVER)

The purpose of this study is to examine the safety and potential effectiveness of a new surgical procedure for treating heart failure. The experimental treatment is performed during standard coronary artery bypass graft (CABG) surgery, and applies radiofrequency energy to heat a portion of the damaged heart muscle. The tissue heating reduces the enlarged heart of patients suffering from ischemic heart failure, and may result in the heart pumping blood more efficiently, thereby improving the functional status of the patient.

Read the detailed description

Heart failure is an important health-care problem, resulting in significant numbers of patients, hospitalizations, and economic costs. The etiology of heart failure is coronary artery disease in approximately two-thirds of cases, and the majority of these patients have experienced prior myocardial infarction. As a consequence of the myocardial infarction, the ventricle undergoes changes in volume and shape, a process referred to as "ventricular remodeling". As the left ventricle enlarges, global systolic function worsens, resulting in heart failure. There are a number of treatment options available to minimize symptoms and somewhat slow disease progression. Unfortunately, even with best conventional drug and device therapies, heart failure patients continue to have high morbidity and mortality rates. The experimental therapy investigated in this study uses a surgical device which employs radiofrequency energy to heat epicardial tissue. The application of heat to a myocardial infarction scar causes it to shrink in size, and correspondingly reduces ventricular volume. The volume reduction may "reverse remodel" the enlarged and dysfunctioning left ventricle to a more normal size and shape. The intent of this clinical study is to evaluate whether radiofrequency heating of the myocardial infarct scar is safe, and determine if the resulting ventricular volume reduction translates into improved clinical and functional outcomes in patients suffering from ischemic heart failure.

Conditions
Heart Failure
Being tested
Radiofrequency heating of the myocardial infarct scar, Coronary Artery Bypass Grafting (CABG) surgery
Keywords
Heart Failure, Cardiomyopathy, Ventricular Dysfunction, Heart Disease
Medical subject headings
Heart Failure, Cardiomyopathies, Ventricular Dysfunction, Heart Diseases

What participants receive

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

  • Radiofrequency heating of the myocardial infarct scarProcedure or surgery

    Radiofrequency energy is applied to the epicardial surface of the heart using an external generator and a hand-held probe to heat myocardial infarction scar.

  • Coronary Artery Bypass Grafting (CABG) surgeryProcedure or surgery

    A standard surgical procedure performed to relieve angina and reduce the risk of death from coronary artery disease. Arteries or veins from elsewhere in the body are grafted to the coronary arteries to bypass atherosclerotic narrowings and improve the blood supply to the coronary circulation supplying the myocardium.

Study groups in NCT00881777
Study groupRoleWhat they receive
RF Heating + CABGExperimentalRadiofrequency heating of the myocardial infarct scar plus Coronary Artery Bypass Grafting (CABG) surgery
Receives: Procedure: Radiofrequency heating of the myocardial infarct scar; Procedure: Coronary Artery Bypass Grafting (CABG) surgery
CABG AloneActive comparatorCoronary Artery Bypass Grafting (CABG) surgery only, without radiofrequency heating of the myocardial infarct scar
Receives: Procedure: Coronary Artery Bypass Grafting (CABG) surgery

What is being measured

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

  1. Change in Left Ventricular End Diastolic and Systolic Volume Indexes as measured by Cardiac MRI/CT

    Measured: 6 Months

  2. Occurrence of any of the following: cardiac hemorrhage/rupture, cardiac tamponade, stroke/transient ischemic attack/renal failure, myocardial infarction, sepsis/cardiac-related infection, re-hospitalization for cardiac cause, or all-cause mortality

    Measured: 6 months

Secondary outcomes (6)

  1. Change in Left Ventricular End Diastolic and Systolic Dimensions, Volumes, and Volume Indexes, and Left Ventricular Ejection Fraction as measured by Cardiac MRI/CT

    Measured: Peri-operative, 6 and 12 months

  2. Change in New York Heart Association Functional Classification and Canadian Cardiovascular Society Angina Grading Scale

    Measured: 1, 3, 6, and 12 months

  3. Change in Cardiopulmonary Exercise Stress Test (Peak VO2 and VE/VCO2 slope)

    Measured: 6 and 12 months

  4. Change in 6-Minute Walk distance

    Measured: 1, 3, 6, and 12 months

  5. Change in Quality of Life Questionnaire score (Minnesota Living With Heart Failure and EuroQol EQ-5D)

    Measured: 1, 3, 6, and 12 months

  6. Occurrence of individual primary safety endpoints, heart failure deaths, heart failure hospitalizations, all-cause hospitalizations, days alive out of the hospital, and neurological assessments (NIH Stroke Scale and Mini-Mental Status Exam)

    Measured: 6 and 12 months

Timeline

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

  1. First posted15 Apr 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionMar 2011
  4. Study completionMar 2011

Why it stopped: Unable to recruit suitable subjects within a reasonable time period.

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00881777
Sponsor's protocol ID
2008-01 Rev. C
Acronym
RECOVER
Status last verified
Jul 2011
First submitted
13 Apr 2009
Last updated
14 Jul 2011
Results posted
No
Data monitoring committee
No

Publications

  • Ratcliffe MB, Wallace AW, Teerlink JR, Hong J, Salahieh A, Sung SH, Keung EC, Lee RJ. Radio frequency heating of chronic ovine infarct leads to sustained infarct area and ventricular volume reduction. J Thorac Cardiovasc Surg. 2000 Jun;119(6):1194-204. doi: 10.1067/mtc.2000.105826.

    PubMed 10838539

  • Victal OA, Teerlink JR, Gaxiola E, Wallace AW, Najar S, Camacho DH, Gutierrez A, Herrera G, Zuniga G, Mercado-Rios F, Ratcliffe MB. Left ventricular volume reduction by radiofrequency heating of chronic myocardial infarction in patients with congestive heart failure. Circulation. 2002 Mar 19;105(11):1317-22. doi: 10.1161/hc1102.105566.

    PubMed 11901042

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Radiofrequency heating of the myocardial infarct scar and Coronary Artery Bypass Grafting (CABG) surgery in people with Heart Failure, run by CoRepair, Inc. at 3 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 9 inclusion and 28 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 14 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Poland, Paraguay. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Unable to recruit suitable subjects within a reasonable time period.). 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?

Change in Left Ventricular End Diastolic and Systolic Volume Indexes as measured by Cardiac MRI/CT (time frame: 6 Months). The study lists 2 primary outcomes in all. 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 NCT00881777, 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 14 Jul 2011.

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