Cardiothoracic Surgery: Clinical Studies Open For Enrollment
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Eligibility
- Male or female at least18 years of age
- All heart transplant recipients who are transplanted with an Organ Care System (OCS) perfused donor heart are eligible for this registry.
Enrollment Status: Enrolling
Principal Investigator
David Spielvogel, MD
Study Information
ClinicalTrials.gov | NCT05915299
Contact for Study Screening
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Eligibility
- Female sex (RECHARGE: Women)
- Black race or Hispanic ethnicity (RECHARGE: Minorities)
- Patient is at least 18 years old
- Multivessel or left main CAD is present for which revascularization is intended and for which there is equipoise between CABG and PCI according to local Heart Team assessment.
- Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires
- Exclusion criteria:
- ST-segment elevation MI within 3 days
- Cardiogenic shock
- Prior PCI within 1 year or any prior cardiac surgery
- Planned hybrid revascularization (PCI after CABG or CABG after PCI)
- Planned single vessel revascularization (other than isolated left main disease)
- Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years *NOTE: The one exception is that surgical or interventional left atrial appendage ligation or occlusion may be performed either during or subsequent to the index procedure if clinically indicated
- Pregnancy (women of child-bearing potential must have a negative pregnancy test within 1 week before randomization) or intent to become pregnant within 1 year after randomization
Enrollment Status: Open to enrollment
Study Information
ClinicalTrials.gov | NCT06399705
Principal Investigator
David Spielvogel, MD
Contact for Study Screening
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Eligibility
- Male or female, 18 Years and older
- Ascending Aortic pathologies warranting surgical repair compatible with the treatment requirements of the ASG device meeting any of the following criteria: Aneurysm
- Fusiform aneurysm (≥50mm or documented growth rate >0.5cm/year)
- Saccular aneurysm (no diameter criteria)
- Pseudoaneurysms (>30 days post-surgery, no diameter criteria) Non-aneurysm
- Penetrating Aortic Ulcers (PAUs) (no diameter criteria)
- Pseudoaneurysms, following open surgical repair of a Type A dissection (>30 days post-surgery, no diameter criteria)
- Anatomic compatibility with ASG device based on Gore Imaging Sciences review
- Treatment must be limited to the ascending aorta
- Lesion location is ≥2cm distal to the most distal coronary artery ostia
- Distal extent of the lesion is located ≥2cm proximal to the origin of the Brachiocephalic Artery (BCA)
- Proximal and distal landing zones must be ≥2cm in length
- Landing zones cannot be heavily calcified, or heavily thrombosed
- Landing zone diameter between 27mm – 48mm
- For patients with prior replacement of the ascending aorta and/or aortic arch by an endovascular or surgical graft, there must be at least ≥2 cm overlap of ASG device and previously implanted graft.
- Exclusion criteria:
- De novo Type A dissection
- Requires immediate treatment
- Dissected great vessels requiring treatment
- Anticipated need for coronary or aortic valve intervention within one-year post treatment
- Any aortic valve repair or replacement including transcatheter aortic valve replacement (TAVR) or coronary artery intervention within 30 days prior to treatment
- Complex percutaneous coronary intervention (PCI) or treatment for acute coronary syndrome requiring Dual Anti Platelet Therapy (DAPT) within 30 days prior to treatment
- Open chest surgical repair within 30 days prior to treatment
- Presence of Intramural Hematoma (IMH) in landing zones
- Prosthetic heart valve in the aortic position that precludes safe delivery of the ASG device
- Aortic insufficiency grade 3 or greater
Enrollment Status: Open to enrollment
Study Information
ClinicalTrials.gov | NCT05800743
Principal Investigator
Junichi Shimamura, MD
Contact for Study Screening
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Eligibility
- Male or female, 18 Years to 90 Years
- Participant weighs ≥ 30 kg
- Planned non-emergent sternotomy with CPB procedure for the following surgeries:
- Multi-vessel CABG
- Valve replacement or repair; ascending aorta surgery permitted if combined with aortic valve replacement/repair
- Combined CABG and valve surgery; inclusion of single-vessel CABG when combined with valve replacement/repair is permitted
- Exclusion Criteria
- Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the Investigator
- Single-vessel CABG without valve surgery is planned
- Off-pump surgery is planned (eg, surgery without CPB).
- Recipient of a solid organ or bone marrow transplantation.
- Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization.
- Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05746559
Principal Investigator
Cary Passik, MD
Contact for Study Screening
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Eligibility
Inclusion Criteria Primary Arm:
- De novo Type A aortic dissection (≤30 days from symptom onset to index endovascular procedure) compatible with the treatment requirements of the ASG device.
- Primarily intended to be treated by placement of the ASG device in the ascending aorta. Distal adjunctive procedures not in contact with the ASG device may be performed during the index endovascular procedure at the discretion of the Investigator.
- Anatomic compatibility of the ascending aorta required for implanting the ASG device:
- Proximal Aortic Landing Zone:
- Primary entry tear must be in the ascending aorta and ≥ 2 cm distal to the most distal coronary artery ostium.
- Total aortic diameter between 27mm – 48mm
- Landing zone must be in native aorta and cannot be heavily calcified or thrombosed.
- Distal Aortic Landing Zone:
- Primary entry tear must be in the ascending aorta and ≥ 2 cm proximal to BCA ostium.
- Landing zone must be in native aorta.
- Adequate aortic length
- Proximal Aortic Landing Zone:
- The Aortic Treatment Team (as defined by the protocol) attest endovascular repair is in the best interest of the patient AND considers the patient to be high-risk for open surgical repair by meeting at least one of the following criteria:
- ≥80 years of age
- Body mass index (BMI) ≥ 35 kg/m2
- History of Respiratory Insufficiency (defined by home O2 usage, exertional dyspnea, imaging evidence of COPD, previous evidence of compromised pulmonary function tests (PFT) on spirometry or other factors as determined by the Investigator)
- Prior Cardiac Surgery
- Hostile Chest (VARC-2 Definition)
- Clinical Frailty Scale 3-7
- Clinical malperfusion (head, gut, lower extremity)
- Transfusion is not possible (e.g., Jehovah’s Witness)
- Renal Dialysis prior to aortic dissection
- Chronic renal insufficiency (eGFR<60 without dialysis or other documented history of chronic kidney disease prior to dissection)
- Age ≥18 years at time of informed consent signature.
- Adequate vascular access via transfemoral or retroperitoneal approach.
- Informed Consent Form (ICF) signed by the subject or legally authorized representative.
- Agrees to comply with protocol requirements, including imaging and 5-year follow-up, as the subject’s condition allows.
Exclusion Criteria Primary Arm:
- Mechanical heart valve in the aortic position.
- Aortic insufficiency grade 3 or greater confirmed during TEE pre-implant.
- Indwelling intravascular device that would interfere with or result in contact with planned repair (e.g., contiguous arch graft, LVAD, TAVR device in continuity with aortic tear).
- Known degenerative connective tissue disease (e.g., Marfan’s or Ehler-Danlos Syndrome).
- Participation in investigational drug or medical device study within one year of enrollment unless approved by the Sponsor.
- Known history of drug abuse within one year of treatment which would affect the ability to obtain follow-up.
- Pregnant at time of procedure.
- Active infected aorta, mycotic aneurysm.
- Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication).
- Life expectancy <12 months due to presence of another comorbid condition.
- Known sensitivities or allergies to the device materials (Previous instance of Heparin Induced Thrombocytopenia type 2 [HIT-2], known hypersensitivity to heparin, or a history of a hypercoagulability disorder and/or state should be considered exclusion if treatment plan includes implant of a TBE device).
- Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
- Coronary malperfusion.
- Catastrophic neurological complications in the 30 days prior to the dissection diagnosis (e.g., progressively worsening symptoms, coma, Glasgow Coma Scale <=8).
- Aortic fistula.
- In circulatory shock (e.g., systolic blood pressure <80 mmHg without inotropes, base deficit > -10 mmol/L or -10 mEq/L) at any time prior to the initiation of the index endovascular procedure.
- In extreme hemodynamic compromise requiring cardiopulmonary resuscitation at any time prior to the initiation of the index endovascular procedure.
- Clinical or radiographic signs of bowel infarction, gastrointestinal hemorrhage, or bowel necrosis (as determined by the implanting physician based on imaging observations, peritoneal signs, surgical exploration, elevated serum lactate levels, low pH, and/or acidosis) at any time prior to the initiation of the index endovascular procedure.
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT06827990
Principal Investigator
Junichi Shimamura, MD
Contact for Study Screening
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Eligibility
- Male or Female, Age ≥ 18 years old
- Heart transplant candidate
Part A – DCD Donor Hearts & DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications):
Inclusion Criteria Primary Arm:
- Donor Inclusion Criteria:
- Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room.
- All DCD donors eligible for functional warm ischemic time criteria ≤ 30 minutes. WIT defined as time from when mean systolic blood pressure (SBP) is <50mmHg (sustained for at least 5 minutes) to aortic cross clamp and administration of old cardioplegia in the donor.
- DBD donor hearts with an expected cross clamp of ≥ 4 hours
- DBD donor hearts with any of the following organ quality concerns, regardless of cross clamp time:
- Donor age ≥ 40 years old
- Unknown downtime
- Insignificant CAD
- LVEF ≤ 50%
- Donor Exclusion:
- Moderate to severe aortic incompetence
Part B – DBD Donor Hearts Currently Used with Cold Storage (New Indication):
- Donor Inclusion Criteria:
- Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room.
- Eligible for randomization to OCS or SCS treatment arms.
- DBD donor hearts with an expected cross clamp time of < 4 hours.
- Donor Exclusion:
- Moderate to severe aortic incompetence
- DBD donor with any of the following organ quality concerns:
- Donor age ≥ 40 years old
- Unknown downtime
- Insignificant CAD
- LVEF ≤ 50%
- Exclusion criteria:
- Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT07145515
Principal Investigator
David Spielvogel, MD
Contact for Study Screening