Is NCT07187115 recruiting in Oakland, CA?

Yes, NCT07187115 is currently recruiting participants at its Oakland, CA location. This atrial fibrillation (af) clinical trial is actively enrolling qualified participants.

How do I join the atrial fibrillation (af) clinical trial in Oakland?

To join this clinical trial in Oakland, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Oakland clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Atrial Fibrillation (AF) Clinical Trial in Oakland, CA

About This Atrial Fibrillation (AF) Study in Oakland

The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources) and to demonstrate its non-inferiority in effectiveness compared to PFA of Pulmonary Veins and LA Posterior Wall (PVI+ PWA) in the treatment of de novo symptomatic drug-refractory persistent atrial fibrillation (PersAF).

Sponsor: Boston Scientific Corporation

Who Can Participate

Inclusion Criteria

≥ 18 years of age, or older if required by local law

Have symptomatic drug-refractory1, persistent AF2, confirmed by both:

Documentation, such as physician note, of persistent continuous AF for \> 7 days and ≤ 365 days and the arrhythmia symptoms

Documentation, within 180 days of enrollment date of either:

A 24-hour continuous ECG recording confirming continuous AF or

Two (2) ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days apart

Willing and capable of providing informed consent

Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center

Willing to receive LUX-Dx™ insertable cardiac monitor (ICM) during the study or already has a LUX-Dx™ ICM that was inserted ≤ 6 months (i.e., within 180 days) of consent, and willing to comply to the LUX-Dx Latitude Clarity transmission instructions

Exclusion Criteria

Any of the following atrial conditions:

Left atrial anteroposterior diameter ≥ 5.5 cm, or if1 LA diameter not available, non-indexed volume \>100 ml (physician note or imaging)

Any prior left atrial ablation

Any prior atrial surgery

Current atrial myxoma

Current left atrial thrombus

Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)

Any of the following cardiovascular conditions:

History of sustained ventricular tachycardia or any ventricular fibrillation

Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data, per Investigator's discretion

AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes

Cardiac devices and implants:

Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices

Implantable loop recorder, other than LUX-Dx

Interatrial baffle, patent foramen ovale or atrial septal defect closure device or patch

Any left atrial appendage closure or occlusion device

Presence of any of the following valvular conditions:

Any prosthetic heart valve, stenotic valves, ring or repair

Moderate to severe mitral valve stenosis

More than moderate mitral regurgitation

Hypertrophic or amyloid cardiomyopathy

Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access

Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 months

Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.

Any of the following conditions at Baseline:

Heart failure associated with NYHA Class III or IV

Most recent documented LVEF \< 40% within the previous 12 months

Body Mass Index (BMI) \> 45.0

Known coagulopathy or bleeding disorder

Contraindication to, or unwillingness to use systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation

Women who are confirmed to be pregnant or lactating at the time of the ablation procedure

Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen

Active malignancy (other than squamous cell carcinoma)

Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration

Known active systemic infection

Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (\>30 pauses per hour) as per the guidelines

Predicted life expectancy less than one year per investigator medical judgement

Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility

Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure

Uncontrolled hypertension (SBP \> 160 mmHg or DBP \> 95 mmHg on two (2) BP measurements at baseline assessment not attributable to white coat syndrome per Investigator opinion

CHA2DS2-VASc score ≥ 5

Known allergic drug reaction to nitroglycerin (excluding hypotension)

Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device

Any of the following congenital conditions:

Congenital heart disease with any clinically significant residual anatomic or conduction abnormality

History of known congenital methemoglobinemia

History of known G6PD deficiency

Any of the following conditions in the medical history:

Solid organ or hematologic transplant, or currently being evaluated for a transplant

Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis

Any documented history of Prinzmetal Angina or severe non-revascularizable coronary disease

Renal insufficiency if an estimated glomerular filtration rate (eGFR) is \< 30 mL / min / 1.73 m2, or with any history of renal dialysis or renal transplant

Any other general health condition that, in the investigator's medical opinion, would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.

Any of the following events less than or equal to 90 days of the consent date:

Myocardial infarction (MI), unstable angina or coronary intervention

Any cardiac surgery

Heart failure hospitalization

Pericarditis or symptomatic pericardial effusion

Gastrointestinal bleeding

Stroke, TIA, or intracranial bleeding

Any active non-neurologic thrombus and/or thromboembolic event

Carotid stenting or endarterectomy

Uncontrolled diabetes mellitus or a recorded HbA1c \> 8.0%

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 Oakland?

Yes, this clinical trial (NCT07187115) has an active research site in Oakland, CA 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.

Atrial Fibrillation (AF) Treatment Options in Oakland, CA

If you're searching for atrial fibrillation (af) treatment options in Oakland, CA, this clinical trial (NCT07187115) 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 Oakland research site is actively enrolling participants for this clinical trial. You'll receive care from experienced atrial fibrillation (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 atrial fibrillation (af) clinical trials near you to find additional studies recruiting in your area.

Atrial Fibrillation (AF) Clinical Trial in Oakland, CA

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