Fall River, MANCT07308847Now EnrollingIRB Ready

Paroxysmal AF Clinical Trial in Fall River, MA

Access cutting-edge paroxysmal af treatment through this clinical trial at a research site in Fall River. Study-provided care at no cost to qualified participants.

Sponsored by Medtronic Cardiac Ablation Solutions

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Expert Care in Fall River

Access paroxysmal af specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related paroxysmal af treatment provided free

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Check if you qualify for this paroxysmal af clinical trial in Fall River, MA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Fall River

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Fall River site if eligible
  4. 4Begin participation

About This Paroxysmal AF Study in Fall River

The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.

Sponsor: Medtronic Cardiac Ablation Solutions

Who Can Participate

Inclusion Criteria

A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or with intervention within 7 days of onset, documented by the following:
a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and
at least 1 electrocardiographically documented episode within 12 months prior to enrollment
Adults who are ≥18 and ≤80 years of age on the day of enrollment.
Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.

Exclusion Criteria

Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration \> 7 days
AF that required three (3) or more distinct cardioversions in the preceding 12 months.
LA anteroposterior \> 5.0 cm (by MRI, CT, or TTE)
Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices
Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
Presence of any pulmonary vein stents
Known pre-existing pulmonary vein stenosis
Pre-existing hemidiaphragmatic paralysis
Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy
Moderate to severe aortic or mitral valve stenosis
Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR)
Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date
Unstable angina
NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 40% measure by acceptable cardiac testing (e.g. TTE), or planned transplant or left ventricular assist device (LVAD)
Severe lung disease, primary pulmonary hypertension, or any lung disease with abnormal blood gases or requiring supplemental oxygen
Rheumatic heart disease
Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder
Contraindication to or unwillingness to use systemic anticoagulation
Documented left atrial thrombus on imaging
Active systemic infection or sepsis
Hypertrophic cardiomyopathy
Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date
Carotid stenting or endarterectomy
History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed
Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
Known allergies or hypersensitivities to adhesives
Body mass index \> 40 kg/m2
Atrial myxoma
Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
Renal insufficiency with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2, or any history of renal failure requiring dialysis or renal transplant
Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
Known drug or alcohol dependency
Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results.
Treatment with Amiodarone within the 3 months prior to enrollment
Amyloid heart disease (cardiac amyloidosis)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Fall River?

Yes, this clinical trial (NCT07308847) has an active research site in Fall River, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Paroxysmal AF Treatment Options in Fall River, MA

If you're searching for paroxysmal af treatment options in Fall River, MA, this clinical trial (NCT07308847) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Fall River research site is actively enrolling participants for this clinical trial. You'll receive care from experienced paroxysmal af specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all paroxysmal af clinical trials near you to find additional studies recruiting in your area.

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