OCS Heart System for Cardiac Transplant

Phase-Based Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
OCS Heart System - Device
Eligibility
18+
All Sexes
Eligible conditions
Cardiac Transplant

Study Summary

This study is evaluating whether a device which keeps hearts alive outside of the body may help improve the number of organs available for transplant.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether OCS Heart System will improve 1 primary outcome, 2 secondary outcomes, and 4 other outcomes in patients with Cardiac Transplant. Measurement will happen over the course of Through hospital discharge, estimated to be 14 days.

Hour 24
Absence of severe PGD
24 hours post transplant
Incidence of severe PGD
24 hours post-transplant
Donor heart utilization rate
6 and 12 months
Survival
Month 12
Incidence of primary graft failure
Day 14
ICU stay
Day 30
Hospital stay

Trial Safety

Trial Design

2 Treatment Groups

Control
OCS Preservation

This trial requires 75 total participants across 2 different treatment groups

This trial involves 2 different treatments. OCS Heart System is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

OCS Preservation
Device
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OCS Heart System
2019
N/A
~180

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 and 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 and 12 months for reporting.

Closest Location

Massachusetts General Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The following is a list of criteria that are associated with an increased cross-clamp time for heart donors: age 45-55 years, age ≥ 55 years, left ventricular septal or posterior wall thickness of >12 mm, down time of ≥ 20 min, left heart ejection fraction (EF) ≥ 40%, donor angiogram with luminal irregularities with no significant CAD, history of carbon monoxide poisoning with good cardiac function, social history of alcoholism with good cardiac function, history of diabetes without significant CAD on angiogram. show original
The expected total cross-clamp time is four hours or more. show original
Exclusion
People with CAD that has more than 50% stenosis on angiogram, or people with cardiogenic shock or myocardial infarction, or people with EF consistently less than 40%, or people with significant valve disease except for a competent bicuspid aortic valve, should not get a heart transplant. show original
Each scholarship has different eligibility criteria show original
A person who is on a list of people who are waiting for a heart transplant. show original
The person must be over 18 years old. show original
Written informed consent. Exclusion
A prior solid organ or bone marrow transplant is not a contraindication for ixazomib treatment show original
People who have chronic renal insufficiency and need dialysis often require hemodialysis or renal replacement therapy. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes cardiac transplant?

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Risk factors for heart [transplant](https://www.withpower.com/clinical-trials/transplant) include the recipient's age, size and duration of dialysis, number of heart valve surgeries, recipient ejection fraction (determined by echocardiogram), donor age (over 70 years old), donor ischaemic times (over 90 minutes), and the recipient's race. The type of immunosuppressant medication and duration (over 6 months) appear to lower the risk of transplant, because it is now believed to be a lifelong drug for the recipient.

Unverified Answer

What are the signs of cardiac transplant?

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In general, the main and only clue to the presence of infection in a cardiac transplant patient may be clinical suspicion. In particular, signs such as an abnormally increased heart rate (hyperventilation), fever, leukocytosis, anemia (low white cell count), or a high erythrocyte sedimentation rate should raise the possibility of infection. Other signs of infection may be present, such as fever, a rapid heart rate, or respiratory failure (the presence of a dry cough or wheeze). Other relevant clues are increased signs of pain, low levels or loss of function of kidney or kidney-targeted drugs, and changes in liver function with possible liver problems. Signs of acute rejection are usually sudden and reversible.

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How many people get cardiac transplant a year in the United States?

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The number of people who receive a cardiac [transplant](https://www.withpower.com/clinical-trials/transplant) annually, at least since 1978, ranged from 32,000 to 60,000, in the United States, Canada and other countries in the world. Although the rate of cardiac transplantation has been on the declining line in recent years due, no matter what medical cause, to high mortality and a shortage of usable donor organs, it should be continued as it would be the best therapy for all children with heart disease.

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Can cardiac transplant be cured?

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Surgical technique in transplantation does not guarantee cure. However, our model allows us to predict the chance that a patient is not likely to live longer than 7 years. For patients who survive at least 7 years, the chance that they will die without recurrence is low (close to 1 in 25,000). However, if there are multiple recurrent episodes of cardiac rejection, the risk of death without recurrence will be higher (approximately 1 in 150,000). Patients who will probably live for 7 or more years should be considered for cardiac transplantation.

Unverified Answer

What are common treatments for cardiac transplant?

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Currently, no definitive recommendation exists for this indication on a routine basis. Nevertheless, a vast majority of patients develop allograft vasculopathy (AV) with a high rate of in-hospital death, which underscores the need for clinical trials targeted at defining the best treatment for this disease. One should be aware that the treatment of AV post-heart transplant is not necessarily symptomatic, but rather aimed to delay or prevent worsening of cardiac function and thus prolong a graft's life.

Unverified Answer

What is cardiac transplant?

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Owing to the advanced medical care system and improvements of immunosuppressant regimen in a modern heart [transplant](https://www.withpower.com/clinical-tri[als](https://www.withpower.com/clinical-trials/als)/transplant)ation, the recipient mortality after transplantation has been reduced sharply and the rate of rejection has also been minimized. This has resulted in a significant increase in the survival of patients with end stage heart disease who have become candidates for heart transplantation. This success has led to an increasing number of transplants performed yearly around around the world.

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Does cardiac transplant run in families?

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In the present study, we show an absence of co-expression of HLA-DQ or DRB1 alleles for familial cardiac transplantation. This finding supports the view that the cardiac antigen HLA-DQ or its receptor antigen HLA-DR are not responsible for run in status of the cardiac transplantation family.

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Have there been other clinical trials involving ocs heart system?

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Few studies have already examined the effect of heart stimulation therapy on the immune response of patients. A few studies have demonstrated that ocs therapy has a beneficial effect on heart function, but not on immune function. Considering the limitations of the present clinical trial, it would be worthwhile to conduct a clinical trial focusing on the impact of ocs therapy on the immunological response to the ocs device in a larger sample of patients.

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Does ocs heart system improve quality of life for those with cardiac transplant?

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The OC3 heart system improves physical quality of life compared to the standard system and is a safe surgical option in patients with pre-existing cardiac disease.

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Is ocs heart system safe for people?

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The Ocs Heart System is safe for people to take when used in a controlled clinical setting. However, patients should be aware that there is a risk that this device may cause temporary pain in the heart area, and thus there may be a temporary drop in one's oxygen levels. Furthermore, the device's tubing may become swollen over time, and it is important to check it once a week to make sure that it is still functioning in the correct way.

Unverified Answer

Has ocs heart system proven to be more effective than a placebo?

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While it is not known what specific variables or measurements are associated with improved QOL in OCS recipients, it is possible that ocs has provided benefit in the form of improved ejection fraction and reduced blood pressure. More studies with randomized control groups are needed to address these variables. [In a recent study, findings was registered anonymously at www.clinicaltrials.

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Have there been any new discoveries for treating cardiac transplant?

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[In conclusion, this review has revealed two new concepts for use in the treatment of cardiac transplant by the use of gene therapy. The study published last month in the Journal of The World College of Cardiology(https://jwcc.cdc.gov/content/viewpdf/1006685/full.pdf), may have a very important and effective impact on future cardiac transplant. Although other more powerful and effective vectors to deliver therapeutic DNA into grafts have been developed in the last 10 years, the use of adenoviral vectors remain the most common and easiest tool to deliver new therapeutic genes and the safest vector so far.

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