Prospective Multi-Site Safety and Effectiveness Study of the Boston Scientific Cardiac Cryoablation System for Drug Refractory, Recurrent Symptomatic Paroxysmal Atrial Fibrillation

New Cryoablation System for Irregular Heartbeat Tested

NCT: NCT06170606 · Status: RECRUITING · Phase: N/A · Sponsor: Boston Scientific Corporation · Started: 2024-06-28 · Est. Completion: 2029-05

Plain English Summary

POLARx Post Approval Study (POLARx PAS) is a Not Applicable clinical trial sponsored by Boston Scientific Corporation studying Paroxysmal Atrial Fibrillation. This study tests a new cryoablation system (Boston Scientific Cardiac Cryoablation System) to treat a common heart rhythm problem. It is for adults with paroxysmal atrial fibrillation (AF) whose symptoms are not controlled by medication. Participants will undergo a procedure using the system, followed by regular check-ups for a year. Alternatives include other types of ablation procedures or continued medication management. The trial aims to enroll 200 participants.

Official Summary

To collect clinical data on safety, effectiveness and procedural success of Boston Scientific's Cardiac Cryoablation System (includes all BSC commercially available POLARx/POLARx Fit catheters) when used to perform pulmonary vein isolation (PVI) in the ablation treatment of de novo Atrial Fibrillation (AF).

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with paroxysmal atrial fibrillation (AF) that hasn't responded well to medications. Individuals must be willing and able to give consent and attend all study appointments. Cannot have had a previous ablation procedure in the left atrium. Cannot have severe valve disease, artificial heart valves, or stents in the pulmonary veins. This trial is studying Paroxysmal Atrial Fibrillation, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how safe the procedure is by tracking serious complications and how effective it is by checking if the irregular heartbeat is controlled after one year. The specific primary outcome measures are: Percentage of Participants With Freedom From Primary Safety Events at 12 Months Post-procedure (Acute and Chronic Events) Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models (12 Months); Percentage of Participants With Freedom From Treatment Failure at 12 Months Post-procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models (12 Months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is important because it evaluates a new cryoablation system that could offer a more effective treatment option for patients with drug-resistant atrial fibrillation, addressing a gap in curr This research targets Paroxysmal Atrial Fibrillation, where improved treatment options are needed.

Investor Insight

This study is a post-approval study for a commercialized device, indicating a market-ready product with potential for widespread adoption if safety and effectiveness are confirmed.

Is This Trial Right for Me?

Ask your doctor about the specific risks and benefits of this cryoablation system compared to other treatments. Participation involves a procedure to isolate pulmonary veins in the heart and follow-up visits for one year. You will need to attend scheduled appointments for monitoring and assessments. This trial is currently recruiting participants. The trial is being conducted at 11 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Subjects indicated for drug refractory, recurrent symptomatic PAF treatment with the Cryoablation System, per physician's medical judgement, and as per standard of care
* Subjects who are willing and capable of providing informed consent;
* Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center;

Exclusion Criteria:

* Any known contraindication to an AF ablation or anticoagulation, including those listed in the IFU as legally approved conditions;
* Any prior LA ablation;
* Known or pre-existing severe PV Stenosis;
* Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings);
* Presence of any pulmonary vein stents;
* Subjects with active systemic infection;
* Subject is unable or not willing to complete follow-up visits and examination for the duration of the study;- Subjects with life expectancy ≤ 1 year per investigator's medical judgement;
* Women of childbearing potential who are, or plan to become, pregnant during the time of the study (assessment per investigator's discretion);

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06170606?

NCT06170606 is a Not Applicable INTERVENTIONAL study titled "POLARx Post Approval Study (POLARx PAS)." It is currently recruiting and is sponsored by Boston Scientific Corporation. The trial targets enrollment of 200 participants.

What conditions does NCT06170606 study?

This trial investigates treatments for Paroxysmal Atrial Fibrillation. The primary condition under study is Paroxysmal Atrial Fibrillation.

What treatments are being tested in NCT06170606?

The interventions being studied include: Boston Scientific Cardiac Cryoablation System (DEVICE). The Boston Scientific Cardiac Cryoablation System is intended for ablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF).The main devices and components of the system consists of the following: * POLARx™ or POLARx™ FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories

What does Not Applicable mean for NCT06170606?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT06170606?

This trial is currently "Recruiting." It started on 2024-06-28. The estimated completion date is 2029-05.

Who is sponsoring NCT06170606?

NCT06170606 is sponsored by Boston Scientific Corporation. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06170606?

The trial aims to enroll 200 participants. The trial is currently recruiting and accepting new participants.

How is NCT06170606 designed?

This is a interventional study, uses na allocation, follows a single_group design, employs none masking.

What are the primary outcomes being measured in NCT06170606?

The primary outcome measures are: Percentage of Participants With Freedom From Primary Safety Events at 12 Months Post-procedure (Acute and Chronic Events) Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models (12 Months); Percentage of Participants With Freedom From Treatment Failure at 12 Months Post-procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models (12 Months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06170606 being conducted?

This trial is being conducted at 11 sites, including Gilbert, Arizona; Phoenix, Arizona; Tucson, Arizona; Torrance, California and 7 more sites (United States).

Where can I find official information about NCT06170606?

The official record for NCT06170606 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06170606. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06170606 testing in simple terms?

This study tests a new cryoablation system (Boston Scientific Cardiac Cryoablation System) to treat a common heart rhythm problem. It is for adults with paroxysmal atrial fibrillation (AF) whose symptoms are not controlled by medication.

Why is this trial significant?

This trial is important because it evaluates a new cryoablation system that could offer a more effective treatment option for patients with drug-resistant atrial fibrillation, addressing a gap in curr

What are the potential risks of participating in NCT06170606?

Potential risks include bleeding, blood clots, stroke, or damage to the esophagus. Common side effects may include temporary chest pain, shortness of breath, or bruising at the insertion site. There is a risk of the procedure not being successful in controlling the irregular heartbeat. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06170606?

Ask your doctor about the specific risks and benefits of this cryoablation system compared to other treatments. Participation involves a procedure to isolate pulmonary veins in the heart and follow-up visits for one year. You will need to attend scheduled appointments for monitoring and assessments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06170606 signal from an investment perspective?

This study is a post-approval study for a commercialized device, indicating a market-ready product with potential for widespread adoption if safety and effectiveness are confirmed. This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will undergo a procedure using the system, followed by regular check-ups for a year. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.