Cardiovascular Surgery

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis

   Rochester, Minn.

   The purpose of this study is to determine the prevalence of TTR-CA in a community-based cohort of moderate and severe aortic stenosis patients using 99mTc-PYP single-photon positive emission computed tomography with computed tomography (SPECT/CT).

2. A Study to Evaluate Wellness Coaching for Caregivers of Thoracic Transplant Candidates

   Rochester, Minn.

   The purpose of this study is to examine the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

   Hypotheses:  Caregivers will have traits and behaviors pre-transplant that will predict caregiver readiness, quality of life, and transplant recipient outcomes. Specifically, thoracic pre-transplant caregivers report stress, symptoms of anxiety or depression, and perceive high caregiver burden. These factors may be amenable to pre-transplant intervention to improve overall patient and caregiver outcomes.

   Aims, purpose, or objectives:  We will conduct a pilot trial to test whether caregivers of heart and lung transplant candidates who receive wellness coaching will experience improvement in caregiver-related distress. We will also explore the relationship between caregiving and factors such as uncertainty, resilience, stress level, and affect.

3. A Study to Evaluate Aortic Dilatation in Patients with Conotruncal Abnormalities

   Rochester, Minn.

   The purpose of this study is to assess operative and postoperative outcomes after aortic valve surgery, evaluate for changes in ascending aorta diameter by comparing pre-operative CT imaging to measurements on follow-up imaging, and examine late outcomes and functional status during the follow-up period with specific focus on mortality, need for re-operation and incidence of aortic dissection.

4. Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

   Rochester, Minn.

   The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.

5. A Study of Sexual Dysfunction in Patients with Hypertrophic Obstructive Cardiomyopathy Undergoing Septal Myectomy

   Rochester, Minn.

   The purpose of this study is to determine how many patients suffer from sexual function problems and ascertain if they are improved or modified by cardiac surgical intervention.

6. Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

   Rochester, Minn.

   Prospective, non-randomized, , multicenter study with two independent arms: * Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. * Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only * Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis. Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional subjects implanted in Continued Access (Primary Study arm)

7. A Study to Evaluate Perceptions of Midline Sternotomy Scar in Children and Young Adults

   Rochester, Minn.

   The purpose of this study is to evaluate how children and young adults perceive their midline sternotomy scars (in terms of appearance, associated symptoms, consciousness, satisfaction with appearance/symptoms, and impact on quality of life)? 

8. MediCool Protocol

   Rochester, Minn.

   The purpose of this study is to assess termination of atrial fibrillation (AF) following delivery of cold treatment to the oblique sinus using an experimental cooling module.

    

9. A Study to Evaluate Noninvasive Ultrasound Elastography of Kidney and Lung in Assessment of Volume Status in ICU Patients

   Rochester, Minn.

   The primary purpose of this study is to assess the feasibility of performing lung and kidney and lung ultrasound elastography among patients with critical illness from different etiologies that could be associated with volume overload.

10. Umbilical Cord Blood Collection and Processing for Severe Congenital Heart Disease

    Rochester, Minn.

    Congenital heart disease (CHD) is an abnormal formation that occurs during the development of a baby’s heart, heart valves and/or large vessels such as the aorta artery. CHD is the most common cause of major congenital defects accounting for almost 30% of all defects (Van der Linde D, JACC 2011). While the statistics vary among studies, the best birth prevalence estimate is 8 per 1000 live births (Bernier PL 2010). In the USA, CHD affects 1% of all births per year (Krasuki & Bashore 2016), with an estimated 40,000 babies born with any type of heart defect every year (Benjamin Emelia 2018).  Twenty-five percentof these are affected by a severe congenital heart defect (https://www.cdc.gov/ncbddd/heartdefects/data.html#References). Children with CHD who survive after the surgical procedures can develop heart failure and require a heart transplant at any time in their lives. Infants born with CHD need immediate medical attention and multiple follow-ups throughout their lives. Besides the social and economic impact of CHD on the individual and family lives, CHD treatment places a significant financial burden on the healthcare system. Simeone et al, (2014) reported that the cost of CHD hospitalization in the US was approximately $5.6 billion in 2019, accounting for 15.1% of the total cost for all pediatric hospitalizations in that year.

    The important improvements in CHD diagnosis and surgical treatment in the last decades has led to an increased survival of newborns affected with heart defects. A large number of CHD can be diagnosed during pregnancy, and the patients can present a broad range of symptoms. Forms of CHD are usually classified based on their severity, from mild to severe. One of the mildest forms of CHD is atrial septal defect, which can be undetectable until adulthood (Hoffman & Kaplan, 2002) and VSD (Penny DJ, 2011). On the other hand, severe CHD that requires multiple palliative surgeries includes single ventricle defects, such as hypoplastic left heart syndrome (HLHS) and tricuspid atresia.

    The survival of infants with CHD will depend on the severity of the defect and the time of diagnosis and treatment received. The one-year survival of newborns with severe or critical CHD (generally any type of surgery/procedures in their first year of life) is estimated to be 75%.

    Stem cell therapy has emerged as a new paradigm of treatment in the field of CHD with promising results. Cardiac regeneration has been the focus of acquired, adult heart disease for many years. However, congenital heart disease with structural abnormalities may also be a good target for other research studies. In fact, the pediatric heart is naturally growing and may be amendable to regenerative strategies. Furthermore, the initial pre-clinical and clinical studies have demonstrated that the delivery of stem cells into the heart of patients with CHD is feasible and safe. Moreover, the cell therapy approach, along with the standard surgical palliation, seems to offer benefits over surgical treatment alone. Even though the number of cell therapy clinical trials for CHD has increased in the last decade, more long-term follow-up studies are needed in this population setting in order to define the role of stem cell therapy in the clinical practice. Therefore, confirming our ability to produce autologous cells (cells from the patient's own body) from patients with severe CHD is an important step towards the long-term goal of being able to discover innovative cell-based protocols.