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Treatment Group for Atrial Fibrillation (SMARTPULSE PAF Trial)

N/A
Recruiting
Research Sponsored by Biosense Webster, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 12 months post ablation procedure
Awards & highlights

SMARTPULSE PAF Trial Summary

The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow.

Eligible Conditions
  • Atrial Fibrillation

SMARTPULSE PAF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 12 months post ablation procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12 months post ablation procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Primary Adverse Events (PAEs)
Percentage of Participants with Freedom from Documented (Symptomatic and Asymptomatic) Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes and Other Failure Modes
Secondary outcome measures
Change From Baseline in Quality-of-Life (QOL) Improvement

SMARTPULSE PAF Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment2 Interventions
Participants with drug refractory, symptomatic paroxysmal atrial fibrillation will receive PFA /radiofrequency (RF) ablation using THERMOCOOL STSF catheter in conjunction with the TRUPULSE generator per the hospital's standard protocol (at discretion of investigator).

Find a Location

Who is running the clinical trial?

Biosense Webster, Inc.Lead Sponsor
122 Previous Clinical Trials
36,337 Total Patients Enrolled
81 Trials studying Atrial Fibrillation
28,254 Patients Enrolled for Atrial Fibrillation
Biosense Webster Inc. Clinical TrialStudy DirectorBiosense Webster, Inc.
1 Previous Clinical Trials
362 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
362 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
CirculationJournal
In-hospital Complications Associated with Catheter Ablation of Atrial Fibrillation in the United States Between 2000 and 2010
Deshmukh, Abhishek, Nileshkumar J. Patel, Sadip Pant, Neeraj Shah, Ankit Chothani, Kathan Mehta, Peeyush Grover, et al.. 2013. “In-hospital Complications Associated with Catheter Ablation of Atrial Fibrillation in the United States Between 2000 and 2010”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.113.003862.
JamaJournal
Comparison of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation in Patients with Paroxysmal Atrial Fibrillation
Wilber, David J., Carlo Pappone, Petr Neuzil, Angelo De Paola, Frank Marchlinski, Andrea Natale, Laurent Macle, et al.. 2010. “Comparison of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation in Patients with Paroxysmal Atrial Fibrillation”. Jama. American Medical Association (AMA). doi:10.1001/jama.2009.2029.
clinicaltrials.govStudy
A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF
2023. "A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06144632.
All > Pflugerville Tx > Greensboro
~167 spots leftby Apr 2025
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