Coronary Artery Bypass SurgeryPhase 1NCT00303641
Safety and Effectiveness of the Medtronic Resting Heart Bypass System in Heart Surgery Patients
A Phase 1 study testing Medtronic Resting Heart Bypass System in people with Coronary Artery Bypass Surgery and Cardiopulmonary Bypass, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The purpose of this study is to determine if the Medtronic Resting Heart Bypass system is safer and results in less inflammatory reaction than traditional bypass machines used in coronary artery bypass surgery. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Coronary Artery Bypass Surgery, Cardiopulmonary Bypass
- What is being tested?
- Medtronic Resting Heart Bypass System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2004to Feb 2006
- Phase
- Phase 1
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients undergoing elective surgical coronary artery bypass grafting (CABG) with use of the cardiopulmonary bypass machine
Who cannot join
- Patients unable to provide written informed consent
- Emergency CABG surgery
- Concomitant CABG + Valvular surgery
- Off-pump CABG surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre, University Hospital
London, Ontario, N6A 5A5
About this study
Official title: A Prospective Randomized Study of the Safety and Effectiveness of the Medtronic Resting Heart System
The purpose of this study is to determine if the Medtronic Resting Heart Bypass system is safer and results in less inflammatory reaction than traditional bypass machines used in coronary artery bypass surgery. We hypothesize that the new Medtronic Resting Heart System is safer and results in much less systemic inflammatory reaction in comparison to the standard cardiopulmonary bypass systems currently in use.
Read the detailed description
Cardiopulmonary bypass (CPB) has played an extremely crucial role in coronary artery bypass grafting (CABG) surgery for the past five decades. During CABG, the CPB machine enables the surgeon to stop the heart and perform the surgery in a bloodless operating field. The CPB machine essentially takes over the job of the heart by oxygenating the blood and then perfusing the entire body. In patients undergoing CABG surgery with CPB, a systemic inflammatory reaction occurs when the blood is taken out of the body and circulated through the CPB machine. This inflammatory reaction is believed to increase postoperative morbidity and prolong hospital stay. The systemic inflammatory reaction results in activation of the complement, coagulation, fibrinolytic and kallikrein cascades, it activates leukocytes and endothelial cells causing expression of adhesion molecules and results in the release of inflammatory mediators such as cytokines. This inflammatory reaction during CPB leads to vasodilation, increased interstitial fluid and can affect organs such as the heart, lungs, brain and kidneys resulting in their dysfunction(s). Elimination of CPB in patients undergoing CABG surgery has resulted in reduction of this inflammatory response. Unfortunately, not all patients are able to undergo CABG without the use of CPB.
Most conventional CPB systems also use cardiotomy suction which returns all the blood collected in the operative field back to the CPB reservoir and then eventually returns it to the patient. This blood is rich in inflammatory mediators and small particles because it has been activated by surgical trauma and by the proteins lining the wound cavity. Returning this blood back into the CPB circuit results in further circulation of inflammatory mediators. Removal of the cardiotomy suction from the CPB system could potentially decrease the inflammatory mediators and reduce the inflammatory response during CPB.
Recently, there have been attempts to decrease the inflammatory reaction caused by the use of CPB by developing better, more effective systems. The Medtronic Resting Heart System is very similar to conventional CPB systems and has been approved for clinical use both in Canada and the United States. It has some potential advantages over traditional bypass machines which include; 1)a fully closed-to-air system that does not allow an air-blood interface which could prevent blood activation, 2)it does not have cardiotomy suction and therefore prevents air, lipids or particulate emboli from being re-introduced into the patient's circulation, 3)it minimizes hemodilution by using smaller and low-prime circuits, possibly decreasing the need for postoperative blood transfusion, 4)the CPB circuit, which is the blood-contacting surface, is coated with Carmeda Bioactive Surface (a heparin bioactive surface), that mimics critical characteristics of vascular endothelium and may prevent further blood activation, and 5)it has an active venous air detector and removal device (VARD) that detects venous air and automatically removes the air which may prevent blood activation. All of these elements are potential benefits which may further reduce the morbidity and inflammation associated with CABG surgery.
Thus far to our knowledge, there have been no studies looking at the inflammatory reaction and morbidity in patients undergoing CABG procedures using more improved cardiopulmonary bypass machines. We are therefore proposing a prospective, randomized trial of the safety and effectiveness of the Medtronic Resting Heart system in CABG surgery.
- Being tested
- Medtronic Resting Heart Bypass System
- Keywords
- Cardiopulmonary bypass, Inflammatory reaction
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Resting Heart Bypass SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein
Cell count
Cytokine levels
Complement
Secondary outcomes (1)
Postoperative blood loss, units of blood transfused, re-operation for bleeding, chest tube drainage, length of ICU stay, neurologic and renal function, infection, atrial fibrillation and overall length of postoperative hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startNov 2004
- Primary completionNov 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass SurgeryStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Bob Kiaii, MD, FRCSC, Principal investigator, Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303641
- Sponsor's protocol ID
- R-04-424
- Status last verified
- Aug 2017
- First submitted
- 15 Mar 2006
- Last updated
- 28 Aug 2017
- Results posted
- No
Publications
Kirklin JK, Westaby S, Blackstone EH, Kirklin JW, Chenoweth DE, Pacifico AD. Complement and the damaging effects of cardiopulmonary bypass. J Thorac Cardiovasc Surg. 1983 Dec;86(6):845-57.
PubMed 6606084Wehlin L, Vedin J, Vaage J, Lundahl J. Activation of complement and leukocyte receptors during on- and off pump coronary artery bypass surgery. Eur J Cardiothorac Surg. 2004 Jan;25(1):35-42. doi: 10.1016/s1010-7940(03)00652-3.
PubMed 14690730Edmunds LH Jr. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 1998 Nov;66(5 Suppl):S12-6; discussion S25-8. doi: 10.1016/s0003-4975(98)00967-9.
PubMed 9869435Matata BM, Sosnowski AW, Galinanes M. Off-pump bypass graft operation significantly reduces oxidative stress and inflammation. Ann Thorac Surg. 2000 Mar;69(3):785-91. doi: 10.1016/s0003-4975(99)01420-4.
PubMed 10750762Gu YJ, Mariani MA, van Oeveren W, Grandjean JG, Boonstra PW. Reduction of the inflammatory response in patients undergoing minimally invasive coronary artery bypass grafting. Ann Thorac Surg. 1998 Feb;65(2):420-4. doi: 10.1016/s0003-4975(97)01127-2.
PubMed 9485239Fransen E, Maessen J, Dentener M, Senden N, Geskes G, Buurman W. Systemic inflammation present in patients undergoing CABG without extracorporeal circulation. Chest. 1998 May;113(5):1290-5. doi: 10.1378/chest.113.5.1290.
PubMed 9596308Jewell AE, Akowuah EF, Suvarna SK, Braidley P, Hopkinson D, Cooper G. A prospective randomised comparison of cardiotomy suction and cell saver for recycling shed blood during cardiac surgery. Eur J Cardiothorac Surg. 2003 Apr;23(4):633-6. doi: 10.1016/s1010-7940(02)00834-5.
PubMed 12694789Aldea GS, Soltow LO, Chandler WL, Triggs CM, Vocelka CR, Crockett GI, Shin YT, Curtis WE, Verrier ED. Limitation of thrombin generation, platelet activation, and inflammation by elimination of cardiotomy suction in patients undergoing coronary artery bypass grafting treated with heparin-bonded circuits. J Thorac Cardiovasc Surg. 2002 Apr;123(4):742-55. doi: 10.1067/mtc.2002.120347.
PubMed 11986603Kaza AK, Cope JT, Fiser SM, Long SM, Kern JA, Kron IL, Tribble CG. Elimination of fat microemboli during cardiopulmonary bypass. Ann Thorac Surg. 2003 Feb;75(2):555-9; discussion 559. doi: 10.1016/s0003-4975(02)04540-x.
PubMed 12607672
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of the Safety and Effectiveness of the Medtronic Resting Heart System
- ClinicalTrials.gov ID
- NCT00303641
- Acronym / sponsor ID
- R-04-424
- Keywords
- Cardiopulmonary bypass, Inflammatory reaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Nov 2004 (actual)
- Primary completion
- Nov 2005 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 17 Mar 2006 (estimated)
- 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 purpose of this study is to determine if the Medtronic Resting Heart Bypass system is safer and results in less inflammatory reaction than traditional bypass machines used in coronary artery bypass surgery. We hypothesize that the new Medtronic Resting Heart System is safer and results in much less systemic inflammatory reaction in comparison to the standard cardiopulmonary bypass systems currently in use.
Detailed description
Cardiopulmonary bypass (CPB) has played an extremely crucial role in coronary artery bypass grafting (CABG) surgery for the past five decades. During CABG, the CPB machine enables the surgeon to stop the heart and perform the surgery in a bloodless operating field. The CPB machine essentially takes over the job of the heart by oxygenating the blood and then perfusing the entire body. In patients undergoing CABG surgery with CPB, a systemic inflammatory reaction occurs when the blood is taken out of the body and circulated through the CPB machine. This inflammatory reaction is believed to increase postoperative morbidity and prolong hospital stay. The systemic inflammatory reaction results in activation of the complement, coagulation, fibrinolytic and kallikrein cascades, it activates leukocytes and endothelial cells causing expression of adhesion molecules and results in the release of inflammatory mediators such as cytokines. This inflammatory reaction during CPB leads to vasodilation, increased interstitial fluid and can affect organs such as the heart, lungs, brain and kidneys resulting in their dysfunction(s). Elimination of CPB in patients undergoing CABG surgery has resulted in reduction of this inflammatory response. Unfortunately, not all patients are able to undergo CABG without the use of CPB.
Most conventional CPB systems also use cardiotomy suction which returns all the blood collected in the operative field back to the CPB reservoir and then eventually returns it to the patient. This blood is rich in inflammatory mediators and small particles because it has been activated by surgical trauma and by the proteins lining the wound cavity. Returning this blood back into the CPB circuit results in further circulation of inflammatory mediators. Removal of the cardiotomy suction from the CPB system could potentially decrease the inflammatory mediators and reduce the inflammatory response during CPB.
Recently, there have been attempts to decrease the inflammatory reaction caused by the use of CPB by developing better, more effective systems. The Medtronic Resting Heart System is very similar to conventional CPB systems and has been approved for clinical use both in Canada and the United States. It has some potential advantages over traditional bypass machines which include; 1)a fully closed-to-air system that does not allow an air-blood interface which could prevent blood activation, 2)it does not have cardiotomy suction and therefore prevents air, lipids or particulate emboli from being re-introduced into the patient's circulation, 3)it minimizes hemodilution by using smaller and low-prime circuits, possibly decreasing the need for postoperative blood transfusion, 4)the CPB circuit, which is the blood-contacting surface, is coated with Carmeda Bioactive Surface (a heparin bioactive surface), that mimics critical characteristics of vascular endothelium and may prevent further blood activation, and 5)it has an active venous air detector and removal device (VARD) that detects venous air and automatically removes the air which may prevent blood activation. All of these elements are potential benefits which may further reduce the morbidity and inflammation associated with CABG surgery.
Thus far to our knowledge, there have been no studies looking at the inflammatory reaction and morbidity in patients undergoing CABG procedures using more improved cardiopulmonary bypass machines. We are therefore proposing a prospective, randomized trial of the safety and effectiveness of the Medtronic Resting Heart system in CABG surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting patients undergoing elective surgical coronary artery bypass grafting (CABG) with use of the cardiopulmonary bypass machine
Key exclusion criteria (4 listed)
- Patients unable to provide written informed consent
- Emergency CABG surgery
- Concomitant CABG + Valvular surgery
- Off-pump CABG surgery
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 |
|---|---|---|
| Medtronic Resting Heart Bypass System | Device | – |
Primary outcome
C-reactive protein
Cell count
Cytokine levels
Complement
1 secondary outcome
Postoperative blood loss, units of blood transfused, re-operation for bleeding, chest tube drainage, length of ICU stay, neurologic and renal function, infection, atrial fibrillation and overall length of postoperative hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Background: PubMed 6606084Kirklin JK, Westaby S, Blackstone EH, Kirklin JW, Chenoweth DE, Pacifico AD. Complement and the damaging effects of cardiopulmonary bypass. J Thorac Cardiovasc Surg. 1983 Dec;86(6):845-57.
- Background: PubMed 14690730Wehlin L, Vedin J, Vaage J, Lundahl J. Activation of complement and leukocyte receptors during on- and off pump coronary artery bypass surgery. Eur J Cardiothorac Surg. 2004 Jan;25(1):35-42. doi: 10.1016/s1010-7940(03)00652-3.
- Background: PubMed 9869435Edmunds LH Jr. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 1998 Nov;66(5 Suppl):S12-6; discussion S25-8. doi: 10.1016/s0003-4975(98)00967-9.
- Background: PubMed 10750762Matata BM, Sosnowski AW, Galinanes M. Off-pump bypass graft operation significantly reduces oxidative stress and inflammation. Ann Thorac Surg. 2000 Mar;69(3):785-91. doi: 10.1016/s0003-4975(99)01420-4.
- Background: PubMed 9485239Gu YJ, Mariani MA, van Oeveren W, Grandjean JG, Boonstra PW. Reduction of the inflammatory response in patients undergoing minimally invasive coronary artery bypass grafting. Ann Thorac Surg. 1998 Feb;65(2):420-4. doi: 10.1016/s0003-4975(97)01127-2.
- Background: PubMed 9596308Fransen E, Maessen J, Dentener M, Senden N, Geskes G, Buurman W. Systemic inflammation present in patients undergoing CABG without extracorporeal circulation. Chest. 1998 May;113(5):1290-5. doi: 10.1378/chest.113.5.1290.
- Background: PubMed 12694789Jewell AE, Akowuah EF, Suvarna SK, Braidley P, Hopkinson D, Cooper G. A prospective randomised comparison of cardiotomy suction and cell saver for recycling shed blood during cardiac surgery. Eur J Cardiothorac Surg. 2003 Apr;23(4):633-6. doi: 10.1016/s1010-7940(02)00834-5.
- Background: PubMed 11986603Aldea GS, Soltow LO, Chandler WL, Triggs CM, Vocelka CR, Crockett GI, Shin YT, Curtis WE, Verrier ED. Limitation of thrombin generation, platelet activation, and inflammation by elimination of cardiotomy suction in patients undergoing coronary artery bypass grafting treated with heparin-bonded circuits. J Thorac Cardiovasc Surg. 2002 Apr;123(4):742-55. doi: 10.1067/mtc.2002.120347.
- Background: PubMed 12607672Kaza AK, Cope JT, Fiser SM, Long SM, Kern JA, Kron IL, Tribble CG. Elimination of fat microemboli during cardiopulmonary bypass. Ann Thorac Surg. 2003 Feb;75(2):555-9; discussion 559. doi: 10.1016/s0003-4975(02)04540-x.
- London Health Sciences Centre, University Hospital, Division of Cardiac SurgeryLink provided by the sponsor.
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Coronary Artery Bypass Graft (CABG)
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.
Bob Kiaii, MD, FRCSC principal investigator
Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre, University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Medtronic Resting Heart Bypass System in people with Coronary Artery Bypass Surgery and Cardiopulmonary Bypass, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 4 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: finished, as of the sponsor's last update on 28 Aug 2017. 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 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.
What does this 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
C-reactive protein. The study lists 4 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 NCT00303641, which also lists 9 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 28 Aug 2017.