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A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF

Evaluating a new catheter and generator for difficult-to-treat PAF.

Recruiting
18-75 years
All
Phase N/A

This study focuses on treating people with Paroxysmal Atrial Fibrillation (PAF), which is when the heart beats irregularly, causing poor blood flow. The treatment uses a special tool called the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter, paired with a TRUPULSE Generator. This system helps isolate the atrial pulmonary veins, which are key in managing the heart's rhythm. People can join the study if they've had at least two PAF episodes in the past six months and have tried but not succeeded with certain heart medications.

Key Points:

  • The study involves several pre- and post-treatment tests and follow-ups.
  • Participants must be able to provide consent and follow study requirements.
  • There are specific conditions that could exclude someone from participating, like certain heart issues or recent heart surgeries.

This study aims to see if this new treatment is safe and works well for people with PAF. Participants should consider their current health and previous treatments before joining.

Study details
    Drug Refractory Paroxysmal Atrial Fibrillation

NCT06144632

Biosense Webster, Inc.

12 October 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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