Cardiothoracic Clinical Trails Move Forward

The Cardiothoracic Surgical Trials Network is a major collaborative effort focusing on surgical approaches for cardiac disease. Two of their trials recently reached enrollment milestones, according to the CTSN.

In August the University of Pennsylvania randomized the 200th patient in the severe ischemic mitral regurgitation (SMR) trial. As of the end of the month, the Network randomized 205 patients in the trial designed to evaluate the efficacy and safety of mitral valve repair and replacement for severe MR patients.

There is a companion trial, the moderate MR (MMR) trial, to evaluate the safety and efficacy of mitral valve repair and coronary artery bypass grafting (CABG) vs. CABG alone.

The goal of these trials is to determine the optimal approach to treatment of patients with ischemic MR, a controversial subject involving significant variations in surgical practice. Investigators expect to complete enrollment in the SMR trial (n=250) in the fall of 2011, and in the MMR trial (n=300) by summer of 202.

Also in August, the University of Virginia randomized the 100th patient in the atrial fibrillation (AF) trial. The Network designed a comparative effectiveness randomized trial of surgical ablation with left atrial appendage (LAA) closure versus LAA closure alone in patients with (longstanding) persistent AF undergoing MVS. According to CTSN, nested within this trial, is a further randomized comparison of 2 different lesions sets (pulmonary vein isolation only and Maze lesion set).

The FDA recently approved expansion from 13 to 23 clinical centers and these new sites are now being launched to enable completion of enrollment in 2012.

Two new CTSN-sponsored cell therapy trials are also in the works.

Left ventricular assist device (LVAD) therapy has become widely used and outcomes have improved over time. However, adverse events are still noted and could be minimized. In addition, quality of life could be improved if the duration of support could be limited. One potential way to do this is by inducing myocardial recovery through cell therapy, according to the CTSN.

In collaboration with the Cardiovascular Cell Therapy Research Network, CTSN has developed a translational trial that is intended to evaluate the safety, and explore the efficacy, of direct myocardial injection of off-the-shelf mesenchymal precursor cells in LVAD recipients. The FDA recently approved the protocol, and start-up activities are underway. The ttraining of site coordinators is scheduled to begin in mid-fall 2011.

The second cell therapy trial planned involves the use of intracoronary injections of autologous cardiac stem cells to be performed following cardiac transplantation. According to the CSTN, this trial will be designed to provide "important exploratory information regarding safety and the ability of stem cells to engraft and differentiate within the scaffold of the transplanted heart."

The rationale for this research is to modulate tolerance of the transplanted heart in order to reduce the incidence of allograft rejection. A pre-IND meeting to discuss the protocol was initiated with the FDA.

In the important area of drug support for cardiac surgery patients, CTSN is collaborating with the VA Cooperative Clinical Studies Program, to design what is intended to be a large, simple trial evaluating the effect of adding ticagrelor to aspirin after coronary artery bypass grafting.

The primary efficacy endpoint in the trial will be MACCE and the primary safety endpoint will be severe bleeding. The sample size will be close to 5,000 patients, and the trial is designed to detect a 20% reduction in the primary efficacy endpoint.

Further information on these and other upcoming and ongoing trials can be found on the CSTN website: www.ctsurgerynet.org along with access to their monthly newsletter.n

The Cardiothoracic Surgical Trials Network is a major collaborative effort focusing on surgical approaches for cardiac disease. Two of their trials recently reached enrollment milestones, according to the CTSN.

In August the University of Pennsylvania randomized the 200th patient in the severe ischemic mitral regurgitation (SMR) trial. As of the end of the month, the Network randomized 205 patients in the trial designed to evaluate the efficacy and safety of mitral valve repair and replacement for severe MR patients.

There is a companion trial, the moderate MR (MMR) trial, to evaluate the safety and efficacy of mitral valve repair and coronary artery bypass grafting (CABG) vs. CABG alone.

The goal of these trials is to determine the optimal approach to treatment of patients with ischemic MR, a controversial subject involving significant variations in surgical practice. Investigators expect to complete enrollment in the SMR trial (n=250) in the fall of 2011, and in the MMR trial (n=300) by summer of 202.

Also in August, the University of Virginia randomized the 100th patient in the atrial fibrillation (AF) trial. The Network designed a comparative effectiveness randomized trial of surgical ablation with left atrial appendage (LAA) closure versus LAA closure alone in patients with (longstanding) persistent AF undergoing MVS. According to CTSN, nested within this trial, is a further randomized comparison of 2 different lesions sets (pulmonary vein isolation only and Maze lesion set).

The FDA recently approved expansion from 13 to 23 clinical centers and these new sites are now being launched to enable completion of enrollment in 2012.

Two new CTSN-sponsored cell therapy trials are also in the works.

Left ventricular assist device (LVAD) therapy has become widely used and outcomes have improved over time. However, adverse events are still noted and could be minimized. In addition, quality of life could be improved if the duration of support could be limited. One potential way to do this is by inducing myocardial recovery through cell therapy, according to the CTSN.

In collaboration with the Cardiovascular Cell Therapy Research Network, CTSN has developed a translational trial that is intended to evaluate the safety, and explore the efficacy, of direct myocardial injection of off-the-shelf mesenchymal precursor cells in LVAD recipients. The FDA recently approved the protocol, and start-up activities are underway. The ttraining of site coordinators is scheduled to begin in mid-fall 2011.

The second cell therapy trial planned involves the use of intracoronary injections of autologous cardiac stem cells to be performed following cardiac transplantation. According to the CSTN, this trial will be designed to provide "important exploratory information regarding safety and the ability of stem cells to engraft and differentiate within the scaffold of the transplanted heart."

The rationale for this research is to modulate tolerance of the transplanted heart in order to reduce the incidence of allograft rejection. A pre-IND meeting to discuss the protocol was initiated with the FDA.

In the important area of drug support for cardiac surgery patients, CTSN is collaborating with the VA Cooperative Clinical Studies Program, to design what is intended to be a large, simple trial evaluating the effect of adding ticagrelor to aspirin after coronary artery bypass grafting.

The primary efficacy endpoint in the trial will be MACCE and the primary safety endpoint will be severe bleeding. The sample size will be close to 5,000 patients, and the trial is designed to detect a 20% reduction in the primary efficacy endpoint.

Further information on these and other upcoming and ongoing trials can be found on the CSTN website: www.ctsurgerynet.org along with access to their monthly newsletter.n

The Cardiothoracic Surgical Trials Network is a major collaborative effort focusing on surgical approaches for cardiac disease. Two of their trials recently reached enrollment milestones, according to the CTSN.

In August the University of Pennsylvania randomized the 200th patient in the severe ischemic mitral regurgitation (SMR) trial. As of the end of the month, the Network randomized 205 patients in the trial designed to evaluate the efficacy and safety of mitral valve repair and replacement for severe MR patients.

There is a companion trial, the moderate MR (MMR) trial, to evaluate the safety and efficacy of mitral valve repair and coronary artery bypass grafting (CABG) vs. CABG alone.

The goal of these trials is to determine the optimal approach to treatment of patients with ischemic MR, a controversial subject involving significant variations in surgical practice. Investigators expect to complete enrollment in the SMR trial (n=250) in the fall of 2011, and in the MMR trial (n=300) by summer of 202.

Also in August, the University of Virginia randomized the 100th patient in the atrial fibrillation (AF) trial. The Network designed a comparative effectiveness randomized trial of surgical ablation with left atrial appendage (LAA) closure versus LAA closure alone in patients with (longstanding) persistent AF undergoing MVS. According to CTSN, nested within this trial, is a further randomized comparison of 2 different lesions sets (pulmonary vein isolation only and Maze lesion set).

The FDA recently approved expansion from 13 to 23 clinical centers and these new sites are now being launched to enable completion of enrollment in 2012.

Two new CTSN-sponsored cell therapy trials are also in the works.

Left ventricular assist device (LVAD) therapy has become widely used and outcomes have improved over time. However, adverse events are still noted and could be minimized. In addition, quality of life could be improved if the duration of support could be limited. One potential way to do this is by inducing myocardial recovery through cell therapy, according to the CTSN.

In collaboration with the Cardiovascular Cell Therapy Research Network, CTSN has developed a translational trial that is intended to evaluate the safety, and explore the efficacy, of direct myocardial injection of off-the-shelf mesenchymal precursor cells in LVAD recipients. The FDA recently approved the protocol, and start-up activities are underway. The ttraining of site coordinators is scheduled to begin in mid-fall 2011.

The second cell therapy trial planned involves the use of intracoronary injections of autologous cardiac stem cells to be performed following cardiac transplantation. According to the CSTN, this trial will be designed to provide "important exploratory information regarding safety and the ability of stem cells to engraft and differentiate within the scaffold of the transplanted heart."

The rationale for this research is to modulate tolerance of the transplanted heart in order to reduce the incidence of allograft rejection. A pre-IND meeting to discuss the protocol was initiated with the FDA.

In the important area of drug support for cardiac surgery patients, CTSN is collaborating with the VA Cooperative Clinical Studies Program, to design what is intended to be a large, simple trial evaluating the effect of adding ticagrelor to aspirin after coronary artery bypass grafting.

The primary efficacy endpoint in the trial will be MACCE and the primary safety endpoint will be severe bleeding. The sample size will be close to 5,000 patients, and the trial is designed to detect a 20% reduction in the primary efficacy endpoint.

Further information on these and other upcoming and ongoing trials can be found on the CSTN website: www.ctsurgerynet.org along with access to their monthly newsletter.n