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

NCT00881777 | Terminated Phase 1

• 1 other identifier: 2008-01 Rev. C
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 3

Brief 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. 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.

Conditions

Heart Failure

Keywords

Heart Failure; Cardiomyopathy; Ventricular Dysfunction; Heart Disease

Outcome Measures

Primary Outcomes (2)

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

  6 Months

• 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

  6 months

Secondary Outcomes (6)

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

  Peri-operative, 6 and 12 months

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

  1, 3, 6, and 12 months

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

  6 and 12 months

• Change in 6-Minute Walk distance

  1, 3, 6, and 12 months

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

  1, 3, 6, and 12 months

Study Arms (2)

RF Heating + CABG

EXPERIMENTAL

Radiofrequency heating of the myocardial infarct scar plus Coronary Artery Bypass Grafting (CABG) surgery

Procedure: Radiofrequency heating of the myocardial infarct scar; Procedure: Coronary Artery Bypass Grafting (CABG) surgery

CABG Alone

ACTIVE COMPARATOR

Coronary Artery Bypass Grafting (CABG) surgery only, without radiofrequency heating of the myocardial infarct scar

Procedure: Coronary Artery Bypass Grafting (CABG) surgery

Interventions

Radiofrequency heating of the myocardial infarct scar PROCEDURE

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.

RF Heating + CABG

Coronary Artery Bypass Grafting (CABG) surgery PROCEDURE

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.

CABG Alone; RF Heating + CABG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Left ventricular end-systolic volume index ≥ 60 ml/m2 as determined by transthoracic echocardiography
• minute walk distance over 150 m
• Peak VO2 (ml/kg/min): 10.0 - 20.0 for males and 9.0 - 18.0 for females

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• CoRepair, Inc.: lead

Study Sites (3)

Sanatorio Italiano

Asunción, Paraguay

Location

The Cardinal Stefan Wyszynski Institute of Cardiology

Warsaw, 04-628, Poland

Location

Silesian Center for Heart Diseases

Zabrze, 41-800, Poland

Location

Related Publications (2)

• 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.

  PMID: 10838539 BACKGROUND

• 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.

  PMID: 11901042 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies; Ventricular Dysfunction; Heart Diseases

Interventions

Coronary Artery Bypass; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 15, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 14, 2011

Record last verified: 2011-07

Locations

PA (1); PL (2)