Valved Graft for Aortic Valve Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new heart device called the Abbott Valved Graft, used in cardiac surgery to replace a heart valve. The goal is to evaluate the device's effectiveness for individuals needing a new valve, whether replacing a natural or an old artificial one. Participants will be divided into two groups, each receiving a different type of the device (CAVGJ or VAVGJ). Candidates who have undergone cardiac surgery to replace a heart valve and do not have issues like intolerance to blood thinners or active infections are suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are intolerant to anticoagulation therapy, you cannot participate.
What is the safety track record for these treatments?
Research has shown that the CAVGJ and VAVGJ devices are types of mechanical heart valves. The FDA has approved these valves for certain uses, indicating they meet safety standards for those purposes. Users of these valves have generally experienced few problems over long periods.
A rare incident with the CAVGJ device involved a leak between the cuff and the artificial vessel. However, such issues are uncommon, and overall, these devices have performed well.
Both devices are generally well-tolerated and have a good safety record based on past data. Discuss any potential side effects or concerns with a healthcare provider.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard surgical options for managing complex vascular grafts, the treatments CAVGJ and VAVGJ offer novel approaches by integrating valve technology directly into the grafts. This integration is designed to improve blood flow dynamics and reduce complications associated with traditional graft procedures, such as clot formation and graft failure. Researchers are particularly excited about these treatments because they could lead to better long-term outcomes and fewer surgeries for patients, making them a potentially groundbreaking advancement in vascular surgery.
What evidence suggests that this trial's treatments could be effective?
This trial will compare two treatments: CAVGJ and VAVGJ. Studies have shown that mechanical aortic valve replacements (AVRs), like those used in the CAVGJ group, help people live longer, especially if they are under 60. Research indicates that these mechanical valves lead to fewer problems over time compared to bioprosthetic valves. In the VAVGJ group, bioprosthetic valves allow blood to flow smoothly through the heart. However, mechanical valves usually have better long-term results because they are less likely to fail. Overall, both treatments are promising, but mechanical valves generally offer better long-term benefits.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Abbott Valved Graft device
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CAVGJ
- VAVGJ
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
CAVGJ
VAVGJ
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abbott Medical Devices
Lead Sponsor
Dr. Etahn Korngold
Abbott Medical Devices
Chief Medical Officer
Medical training at Harvard Medical School and Massachusetts General Hospital
Robert B. Ford
Abbott Medical Devices
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business
Citations
Long‐Term Outcomes of Patients Undergoing Aortic Root ...
CAVGR with mechanical valves is associated with better long‐term outcomes in comparison with CAVGR with bioprosthetic valves.
A comparison of outcomes in men 11 years after heart- ...
Conclusions: After 11 years, the rates of survival and freedom from all valve-related complications were similar for patients who received mechanical heart ...
New Study Finds Mechanical Valves Offer Superior Long ...
Mechanical aortic valve replacements (AVRs) provide significant long-term survival benefits for patients aged 60 and younger compared to bioprosthetic valves.
Clinical Performance of Mechanical Aortic Valve Prostheses
The National Patient Register was used to collect baseline characteristics and outcomes data. The primary outcome was all-cause mortality.
Twenty-Year Outcomes Following Porcine Versus Bovine ...
Stented porcine and bovine pericardial bioprostheses show comparable long-term survival following AVR, though porcine valves have lower reintervention rates.
6.
accessdata.fda.gov
accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=14019088&pc=LWQMAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS ...
An event of leaking between the connection of the cuff and the artificial vessel was reported.A returned device inspection could not be performed as the device ...
7.
cardiovascular.abbott
cardiovascular.abbott/us/en/hcp/products/structural-heart/surgical-valve-solutions/masters-mechanical-valves.htmlMasters Mitral and Aortic Mechanical Valves
The Masters Series Mechanical Heart Valves are rotatable, bileaflet valves designed for implantation in the aortic or mitral position.
Devices@FDA
Device, SJM MASTERS SERIES AORTIC VALVED GRAFT (MODEL CAVGJ), AND THE SJM MASTERS HP VALVED GRAFT (MODEL VAVGJ). Generic Name, HEART-VALVE, MECHANICAL.
9.
manuals.eifu.abbott
manuals.eifu.abbott/content/dam/av/manuals-eifu/global/AL/en/ARTMT600261317_C.pdfMasters Series™/Masters Series™ HP Mechanical Heart ...
Summary of Safety and Clinical Performance (SSCP). A summary of the safety and clinical performance (SSCP) for this device is available at https://ec.europa ...
Premarket Approval (PMA) - FDA
Device, MECHANICAL HEART VALVE, MASTERS SERIES COATED AORTIC VALVED GRAFT, MODEL CAVGJ-514 00. Generic Name, HEART-VALVE, MECHANICAL.
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