Clinical Research Trials

Assert-IQ™

This is a prospective, real-world post-market study to collect and evaluate data regarding the performance of the enhanced atrial fibrillation detection algorithm of the Assert-IQ Implantable Cardiac Monitor (ICM) device. The patient population will be subjects who are diagnosed with symptomatic, drug-refractory paroxysmal or persistent AF, and are scheduled to receive an Assert-IQ ICM device. The inserted Assert-IQ ICM will be compared to that of a simultaneous Holter monitor worn by the subjects over a minimum 72-hour and up to 7 days period in the first month after ICM implantation.

Companion AI

In this study, patients indicated for an AFib ablation can take part in this trial’s objective to observe the medium-to-long-term safety and performance outcomes after ablation utilizing the VX1 and all future models or version of Volta Medical created software.

Restart

Patients that are scheduled for a redo AFib ablation with a documented episode of Afib may qualify. This study involves an electrogram (EGM)–based approach following different operators as they redo ablations and recording that data for future improved outcomes.

SmartPulse AF

For those with paroxysmal AFib scheduled for an ablation, this is a prospective clinical evaluation of the PF/RF ablation system (THERMOCOOL SMARTTOUCH™ SF (STSF) Catheter and TRUPULSE™ Generator) to demonstrate safety and effectiveness of the system for the treatment of drug refractory Paroxysmal Atrial Fibrillation (PAF) comparing to corresponding performance goals.

ADVANCE LAA

The ADVANCE LAA study is intended to characterize real-world outcomes of patients receiving the commercially available Amulet™ device with their LAAO procedure. The Amulet device is used to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients.

Catalyst

Patients with AFib can be screened for the Catalyst study which compares left atrial appendage occlusion therapies: the Amplatzer™ Amulet™ as compared to a commercial novel oral anticoagulant (NOAC). This randomized study investigates the Amulet device’s ability to reduce risk for ischemic stroke and systemic embolism as an alternative to oral anticoagulants.

Conformal

Patients with AFib can be screened for a new left atrial appendage (LAA) closure device called CLAAS^® available from Conformal Medical, Inc. The CLAAS device has a spongy edging that helps conform to your left atrial appendage. Patients are randomly selected to receive either a CLAAS device or the current LAA device (either WATCMAN™ or Amulet™).

HEAL–IST

This study is for patients with inappropriate sinus tachycardia (IST) and an intolerance to rate control medications/antiarrhythmic drugs (AADs). The goal is to evaluate the safety and effectiveness of a hybrid sinus node ablation procedure for the treatment of systematic drug-refractory/drug-intolerant IST.

IST Registry

For those who have been diagnosed with IST/POTS and have a planned ablation, the IST Registry is an observational collection of data for outcomes of IST and POTS treatment. Participants can take part retrospectively or prospectively for trial data collection.

Information on the HEAL-IST Clinical Trial

What is the purpose of this trial?

The purpose of this trial is to learn more about the safety and effectiveness of the AtriCure ISOLATOR Synergy Surgical Ablation System in patients who have been diagnosed with IST and continue to experience symptoms of IST when previous treatments, including medications, have not worked.

The ISOLATOR Synergy Ablation System is currently cleared by the United States Food and Drug Administration (FDA) for the indication of ablating cardiac tissue during surgery.

Caution: The use of the ISOLATOR Synergy Ablation System for the treatment of inappropriate sinus tachycardia (IST) is investigational.

Eligibility – Participation

Your doctor will help you determine whether you are eligible. Ask your doctor about the trial and whether it is the right treatment for you.

If successful, this treatment may reduce your IST-related symptoms. Potential effects may include reduction of average heart rate, improvement in heart rate variability, and improvement in overall quality of life.

To learn more about this trial and clinical trials in general, please visit Clinical trials.

If you are interested in learning more about HEAL-IST trial, please email Brooke Butler.

VT Pass

This study’s goal is to confirm the long–term safety and effectiveness of the FlexAbility™ Ablation Catheter, the FlexAbilty SE (Sensor Enabled), for providers to use before antiarrhythmic medications or implantable cardioverter defibrillators (ICDs) due to their limited efficacy or shock required methods. All devices used in this study are FDA-approved with the FlexAbility SE and cardiac mapping system.

Aim Higher

Patients with symptomatic heart failure, with an ejection fraction (EF) between 40–60% may have the opportunity to participate in the Aim Higher study. This study uses the Optimizer^® Smart Mini System which was approved by the FDA for commercial use for the treatment of patients with systolic heart failure and left ventricular EF between 25–45%.

TAP-CHF

The purpose of TAP-CHF is to evaluate safety and efficacy of catheter ablation vs. AAC therapy in Phase 1 for patients with persistent or recurrent heart failure. Phase 2 involves eval of optimized HF therapy with and without CardioMEMS for HF therapy optimization in Phase 1 patients with AF and class 3 HF despite rhythm control treatment.