Research Trials

CIS Houma

• ECG Belt (Follow-up)
  • The purpose is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling. The ECG Belt Research System will be used at implant and follow-up to help implanters choose a suitable LV pacing site within the recommended locations for LV lead implantation and optimize pacing vector/timing parameters in line with the EHRA/HRS 2012 expert consensus statement.
• EV ICD (Follow-Up)
  • The Medtronic EV ICD System (defibrillator and lead) is indicated for the automated treatment of patients who have experienced, or are at significant risk of developing, life threatening ventricular tachyarrhythmias. The main purpose of the EV ICD Pivotal study is to demonstrate safety and efficacy of the EV ICD System.
• Catalyst (Active/Enrolling)
  • The objective of this trial is to evaluate the safety and effectiveness of the Amulet device compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy.
• CSPOT (Enrolling)
  • Compare the electrical synchronization response of CSPOT pacing configuration to CSP-only and traditional CRT (See section 10.7.1) in patients undergoing a CRT implant, using the SDAT ECG-belt metric.

CIS Houma

• Performance II (Active/Enrolling)
  • To evaluate the safety and effectiveness of the Neuroguard IEP System in subjects for the treatment of carotid artery stenosis at elevated risk for adverse events following carotid endarterectomy

CIS Houma

• Horizon (Follow-Up)
  • This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
• Victorion II (Active/Enrolling)
  • The primary objective of this study is to demonstrate the superiority of inclisiran compared to placebo in reducing the risk of 3P-MACE (composite of CV death, non-fatal MI and non-fatal ischemic stroke) in participants with established ASCVD and a LDL-C >1.8 mmol/L (70 mg/dL)

CIS Opelousas

• Horizon (Follow-Up)
  • This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
• Victorion II (Active/Enrolling)
  • The primary objective of this study is to demonstrate the superiority of inclisiran compared to placebo in reducing the risk of 3P-MACE (composite of CV death, non-fatal MI and non-fatal ischemic stroke) in participants with established ASCVD and a LDL-C >1.8 mmol/L (70 mg/dL)

CIS Lafayette General

• Victorion II (Active/Enrolling)
  • The primary objective of this study is to demonstrate the superiority of inclisiran compared to placebo in reducing the risk of 3P-MACE (composite of CV death, non-fatal MI and non-fatal ischemic stroke) in participants with established ASCVD and a LDL-C >1.8 mmol/L (70 mg/dL)

None at this time.

CIS Houma

• Aegis II (Active/Enrolling)
  • CSL112 is indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in acute coronary syndrome. (ACS) patients diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and exclusive of unstable angina, including those managed with percutaneous coronary intervention or medically managed.
• CADFEM (Active/Enrolling)
  • This trial is a prospective, multicenter, non-randomized, non-blinded, study to collect and store resting phase signals and subject meta data that will be used to develop, optimize and test machine-learned algorithms in future studies conducted by Analytics 4 Life.

CIS Lafayette General

• Aegis II (Active/Enrolling)
  • CSL112 is indicated to reduce the risk of cardiovascular (CV) death,myocardial infarction (MI), and stroke in acute coronary syndrome. (ACS) patients diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and exclusive of unstable angina, including those managed with percutaneous coronary intervention or medically managed.
• CADFEM (Active/Enrolling)
  • This trial is a prospective, multicenter, non-randomized, non-blinded, study to collect and store resting phase signals and subject meta data that will be used to develop, optimize and test machine-learned algorithms in future studies conducted by Analytics 4 Life.
• ECLIPSE (Active/Enrolling)
  • To evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES). This is a prospective, randomized one to one (1:1), multi-center trial designed to evaluate vessel preparation with Orbital Atherectomy (OA) compared to conventional balloon angioplasty technique prior to stent implantation for the treatment of severely calcified coronary artery lesions.

CIS Baton Rouge

• ECLIPSE (Active/Enrolling)
  • To evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES). This is a prospective, randomized one to one (1:1), multi-center trial designed to evaluate vessel preparation with Orbital Atherectomy (OA) compared to conventional balloon angioplasty technique prior to stent implantation for the treatment of severely calcified coronary artery lesions.

CIS Lafayette General Medical Center

• CordiO HearO (Enrolling)
  • To determine the sensitivity and Unexplained Priority Notification Rate (UPNR) of Cordio Hear OTM in detecting impending episodes of heart failure decompensation requiring intervention.

CIS Houma

• Alive (Active/Enrolling)
  • The purpose of the study is to demonstrate the safety and effectiveness of the BioVentrix Revivent TC System for the treatment of LV antero-septal aneurysms/scars in patients with symptomatic heart failure.
• Beat HF (Follow-up)
  • The BAROSTIM NEO - Baroreflex Activation Therapy for Heart Failure is a prospective, randomized trial in subjects with reduced ejection fraction heart failure. Subjects will be randomized in a 1:1 ratio to receive Barostim Activation Therapy with an implanted BAROSTIM NEO System in addition to medical management or to receive medical management alone (no device implant).
• Reduce LAP HF II (Follow-up)
  • The primary objective of this randomized controlled clinical trial is to evaluate the clinical efficacy and safety of the IASD System II in symptomatic heart failure patients with an LV ejection fraction ≥40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT).
• CorCinch HFrEF (Active/Enrolling)
  • The objective of this trial is to evaluate the safety and performance of the AccuCinch system in patients with HFrEF.
• Rebalance (Active/Enrolling)
  • The objective of this clinical evaluation is to assess the safety and initial effectiveness of catheter-based unilateral ablation of the right greater splanchnic nerve (GSN) in subjects having heart failure with preserved ejection fraction (HFpEF).
• Victor (Active/Enrolling)
  • To evaluate the efficacy of vericiguat compared with placebo on reducing the risk of cardiovascular death or heart failure hospitalization. Also to evaluate the efficacy of vericiguat compared with placebo on reducing the risk of cardiovascular death.
• CordiO HearO (Enrolling)
  • To determine the sensitivity and Unexplained Priority Notification Rate (UPNR) of Cordio Hear OTM in detecting impending episodes of heart failure decompensation requiring intervention.

CIS Lafayette General

• Victor (Active/Enrolling)
  • To evaluate the efficacy of vericiguat compared with placebo on reducing the risk of cardiovascular death or heart failure hospitalization. Also to evaluate the efficacy of vericiguat compared with placebo on reducing the risk of cardiovascular death.

CIS Opelousas

• Victor (Active/Enrolling)
  • To evaluate the efficacy of vericiguat compared with placebo on reducing the risk of cardiovascular death or heart failure hospitalization. Also to evaluate the efficacy of vericiguat compared with placebo on reducing the risk of cardiovascular death.

CIS Houma

• Target BP I (Active/Enrolling)
  • To obtain an assessment of the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine System Kit (also referred to as Peregrine Kit) in uncontrolled hypertensive subjects when used in combination with antihypertensive medications.

CIS Lafayette General Medical Center

• Elegance (Pending)
  • Collection of Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.

CIS Houma

• Ranger II (Follow-up)
  • To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA).
• SAVAL (Follow-up)
  • To demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs percutaneous transluminal angioplasty (PTA).
• The Chocolate Touch Study (Follow-up)
  • To show sufficient safety and effectiveness of the Chocolate Touch® for use in superficial femoral or popliteal arteries with the intention of obtaining regulatory approval to market this device in the US.
• Illuminate BTK (Follow-up)
  • The purpose of this study is to demonstrate the safety and effectiveness of the Stellarex™ 0.014” OTW drug-coated angioplasty balloon (Stellarex balloon) for treatment of lesions in the popliteal or infra-popliteal arteries compared to a plain old balloon angioplasty (POBA) catheter. In addition, reference data on Subjects enrolled in the Vessel Preparation Registry will be obtained for the treatment of non-crossable and/or failed pre-dilatation lesions in the popliteal or infrapopliteal arteries.
• STAND (Active/Enrolling)
  • To evaluate the safety and effectiveness of using the MicroStent® Peripheral Vascular Stent System, hereafter referred to as the MicroStent® System, for the treatment of infrapopliteal lesions in subjects with peripheral arterial disease.
• Life BTK (Follow-Up)
  • To evaluate the safety and efficacy of the ESPRIT BTK, compared to PTA, in the planned treatment of diseased infrapopliteal lesions in patients with critical limb ischemia with up to two de novo or restenotic (prior PTA) lesions in separate vessels.
• MIMICS-3d-USA Study (Follow-Up)
  • This study evaluates safety, effectiveness, and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention.
• Elegance (Enrolling)
  • Collection of Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.
• IGuideU (Enrolling)
  • The primary objective of this study is to determine whether the interrogation of the deep venous system (iliac-common femoral veins) for deep venous obstruction (DVO) by multiplanar venography (MPV) plus intravascular ultrasound (IVUS), with subsequent interventional treatment determined and guided by IVUS (interrogation group), results in improved clinical outcomes when compared to deferred interrogation of the deep venous system (deferredinterrogation group).
• Dexterity AFP (Enrolling)
  • Limit the rate of clinically relevant loss of primary patency in the target fem-pop vein segment at 6 months following the procedure.
• Dexterity SCI (Enrolling)
  • Limit the rate of clinically relevant loss of primary patency at 6 months following the procedure. Limit the incidence of composite major adverse events (MAE) at 30 days following treatment of an obstruction in the femoropopliteal segment.

CIS Lafayette General

• Elegance (Pending)
  • Collection of Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.
• Bolt (Pending)
  • The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment.

CIS Houma

• Cardiac Implants (Enrolling)
  • The primary objective is to evaluate the safety and performance of delivery & implantation of the annuloplasty ring and adjustment of the ring approximately 90 days following implantation. The secondary objectives are to evaluate the long-term safety of the device and the effects of the device on echocardiographic, functional and quality of life parameters.
• Empower (Enrolling)
  • The primary objective of the study is to evaluate the safety of deploying and implanting the Carillon device in the coronary sinus/great cardiac vein in patients with functional mitral regurgitation.
• COREVALVE (Follow-up)
  • Expanded Use - To evaluate the safety and efficacy of the Medtronic CoreValve® System for the treatment of symptomatic severe aortic stenosis in subjects with significant comorbidities in whom the risk of surgical aortic valve replacement has a predicted operative mortality or serious, irreversible morbidity risk of ≥50% at 30 days.
• SURTAVI (Follow-up)
  • The purpose of this study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.
• CoreValve Low Risk (Follow-up)
  • Demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is non-inferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.
• AltaValve (Active/Enrolling)
  • To assess safety and performance of the AltaValve for the treatment of severe MR in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.
• Triluminate (Active/Enrolling)
  • The objective of this trial is to evaluate the safety and effectiveness of the TripClipTM device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR) who have been determined by the site's local heart team to be at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.
• EXPAND TAVR (Pending)
  • The primary safety objective is to demonstrate that the composite rate of all-cause mortality, all stroke, life-threatening or fatal bleeding (BARC Type 3 or 4), acute kidney injury (VARC 3 - Stage IV), hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention at 30 days in the device arm is less than the performance goal.

CIS Houma

• Thermography (Enrolling)
  • To explore the efficacy of Thermography, as an adjunct tool, for the assessment of insufficient valves in patients with chronic venous insufficiency.

CIS Opelousas

• Flash (Follow-Up)
  • The primary study objective is to evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice.
• Clout (Follow-Up)
  • The primary objective of this study is to evaluate real world patient outcomes after treatment of acute and non‐acute lower extremity deep venous thrombosis (DVT) with the ClotTriever Thrombectomy System.