Heart and Vascular
Clinical Trials

Heart and vascular clinical trials

Our structural heart clinical trials — ENROLLING

• AlIGN (JenaValve)

  This study involves the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart, which is intended to help treat symptomatic severe aortic regurgitation. 
  
  Visit ClinicalTrials.gov | NCT04415047

• APOLLO

  Multi-center, global, prospective, non-randomized, interventional, pre-market trial for Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in Patients with Severe Symptomatic Mitral Regurgitation.
  
  Visit ClinicalTrials.gov | NCT03242642

• ARISE II

  Evaluation of the GORE® Ascending Stent Graft in the Treatment of Lesions of the Ascending Aorta.
  
  Visit ClinicalTrials.gov | NCT05800743

• ARTIST

  A Study to evaluate Safety and Effectiveness of the JenaValve Trilogy™ Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients with Aortic Regurgitation.
  
  Visit ClinicalTrials.gov | NCT06608823

• ENVISION

  ENVISION is a prospective, multi-center study to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.
  
  Visit ClinicalTrials.gov | NCT06445608

• PICANTE

  Evaluates the outcomes of the KARDION CORY P4 Systems, a mechanical circulatory support device that provides assistance to the heart in patients with coronary artery disease, especially those experiencing cardiogenic shock (a condition where the heart suddenly can't pump enough blood) in subjects who require hemodynamic support during a high-risk PCI procedure.
  
  Visit ClinicalTrials.gov | NCT06445608

• Prevail Global

  A Randomized Controlled Study to evaluate the clinical safety and efficacy of the investigational Prevail DCB, a paclitaxel coated balloon, in treating patients undergoing coronary angioplasty.
  
  Visit ClinicalTrials.gov | NCT06535854

• RESTORE

  Evaluates valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
  
  Visit ClinicalTrials.gov | NCT06777368

• TANDEM-II EFS

  Multi-center, prospective and pre-market study to evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System that combines repair and replacement to provide the right solution for the right heart, a minimally invasive solution for severe Tricuspid Regurgitation.
  
  Visit ClinicalTrials.gov | NCT05913908

• TRICAV-I

  This is a prospective multicenter clinical investigation designed to evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve System for improving outcomes in symptomatic subjects with severe Tricuspid Regurgitation deemed by the local Heart Team to be at high risk for tricuspid valve surgery.
  
  Visit ClinicalTrials.gov | NCT06137807

• TTVR

  Multi-center, prospective, gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve to treat tricuspid regurgitation.
  
  Visit ClinicalTrials.gov | NCT04433065

• TWIST EFS (TMVR)

  This is a multi-center, First-In-Human, prospective early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system in patients with Clinically significant, symptomatic mitral regurgitation and High risk for open-heart surgery.
  
  Visit ClinicalTrials.gov | NCT04919980

Our structural heart clinical trials — COMING SOON

• ARISE III

  Prospective, multicenter, non-randomized, single-arm study to evaluate the safety and effectiveness of the GORE® Ascending Stent Graft device for the treatment of de novo Type A aortic dissections in patients considered to be high-risk for open surgical repair.
  
  Visit ClinicalTrials.gov | NCT06827990

• Laplace EFS

  Early Feasibility (EFS), prospective, single-arm, multi-center study to evaluate safety and technical feasibility of the Laplace Laplace Transcatheter Tricuspid Valve Replacement TTVR System in the treatment of severe, symptomatic tricuspid regurgitation patients.
  
  Visit ClinicalTrials.gov | NNCT06183684

• MOCA-II

  A prospective, multicenter, international single-arm, pivotal clinical study designed to validate the performance of the Controlled Flow Infusion System (CoFI) in detecting Microvascular obstruction (MVO) in STEMI subjects.
  
  Visit ClinicalTrials.gov | NCT06909578

• SHIELD

  A Prospective, Randomized, Multicenter, Single-Blind Trial to Assess the Safety and Effectiveness of the EnCompass F2 Cerebral Protection System vs. Standard of Care (unprotected or Sentinel® Cerebral Protection System) during Transfemoral Transcatheter Aortic Valve Replacement .
  
  Visit ClinicalTrials.gov | NCT06689839

Electrophysiology and Heart Failure clinical trials — ENROLLING

• AIM Higher

  Prospective, multi-center, randomized, quadruple-blind, sham-controlled, two-part embedded trial of the safety and efficacy of CCM therapy delivered via the OPTIMIZER Smart Mini System in subjects with heart failure and a reduced Left ventricular ejection fraction.
  
  Visit ClinicalTrials.gov | NCT05064709

• Disrupt-AF

  The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation.
  
  Visit ClinicalTrials.gov | NCT06335082

• IMPRoVED AF

  This is a post-market, prospective, multi-center, randomized-controlled clinical study designed to compare clinical outcomes following use of forward-solution computational 12-lead ECG mapping system (vMap®) fin patients indicated to undergo ablation procedures for persistent and recurrent Atrial Fibrillation.
  
  Visit ClinicalTrials.gov | NCT06935591

• ULTRA-HFIB-Redo Pilot

  This is a Prospective, controlled, single-blind, randomized clinical trial to determine the role of adjunctive renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension scheduled for a redo AF ablation procedure for paroxysmal or persistent AF.
  
  Visit ClinicalTrials.gov | NCT05988411

Electrophysiology and Heart Failure clinical trials — COMING SOON

• COHERENT-AF

  Evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System for the treatment of atrial fibrillation.
  
  Visit ClinicalTrials.gov | NCT06784466

• PROSPECT

  Evaluate the safety and effectiveness of the FARAPULSE Pulse Field Ablation System for the treatment of symptomatic atrial fibrillation and/ or atrial flutter.
  
  Visit ClinicalTrials.gov | NCT06765356

• REACT-AF

  A multicenter prospective, randomized, trial comparing continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.
  
  Visit ClinicalTrials.gov | NCT05836987

• Sphere-Per-AF-PAS

  The study evaluates the long-term effectiveness and safety of the Sphere-9 Catheter and Affera Ablation System in a post-approval setting for the treatment of drug refractory, recurrent, symptomatic, persistent Atrial Fibrillation.
  
  Visit ClinicalTrials.gov | NCT06858306

Endovascular Trials — ENROLLING

• POWER PAD2

  POWER PAD 2 is a prospective, single-arm, multicenter, non-randomized clinical study designed to demonstrate the safety and effectiveness of the Amplitude Vascular Systems (AVS) Pulse Intravascular Lithotripsy™ (Pulse IVL™) System for treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease.
  
  Visit ClinicalTrials.gov | NCT06457685

• StAAAble

  This is a prospective, randomized, controlled, multi-center, clinical trial to demonstrate efficacy of the Nectero EAST System comprised of a dual-balloon delivery catheter and stabilizer mixture for stabilization of abdominal aortic aneurysms.
  
  Visit ClinicalTrials.gov | NCT06001918

Endovascular Trials — COMING SOON

• AcoArt Litos BTK Global

  Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of AcoArt LitosTM Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon versus Non-Coated Standard Balloon Angioplasty for the Treatment of Infrapopliteal Obstructions in Patients with Chronic Limb-Threatening Ischemia.
  
  Visit ClinicalTrials.gov | NCT06330493

• Celect Platinum

  This prospective, observational, post-market study to collect data on the Celect Platinum Vena Cava Filter Sets and the Günther Tulip Vena Cava Filter Retrieval Set to confirm continued safety and performance of the devices.
  
  Visit ClinicalTrials.gov | NCT05881798

• TRUST

  This is a prospective, multi-center, pivotal study to demonstrate the safety and effectiveness of the Laguna Thrombectomy System a medical device designed for the non-surgical removal of emboli or thrombi from the peripheral vasculature for the treatment of pulmonary embolism.
  
  Visit ClinicalTrials.gov | NCT06041594

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