Is NCT05988411 recruiting in Charleston, SC?

Yes, NCT05988411 is currently recruiting participants at its Charleston, SC location. This paroxysmal atrial fibrillation clinical trial is actively enrolling qualified participants.

Is participation in this Charleston 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.

Paroxysmal Atrial Fibrillation Clinical Trial in Charleston, SC

Q: How do I join the paroxysmal atrial fibrillation clinical trial in Charleston?

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

About This Paroxysmal Atrial Fibrillation Study in Charleston

This is a Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial. The purpose of the study is to determine the role of adjunctive renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension scheduled for a redo AF ablation procedure for paroxysmal or persistent AF. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).

Sponsor: Vivek Reddy

Who Can Participate

Inclusion Criteria

Planned for a redo AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as successful pulmonary vein isolation, if needed, as well as bidirectional block of any attempted anatomic lesion sets such as cavotricuspid isthmus line, roofline, mitral line and superior vena cava isolation, must have been completed). Note: the clinical recurrences must primarily be atrial fibrillation, and not atrial flutter/tachycardia (that is, a prospective patient may have a AFL/AT recurrences, but AF must be the dominant recurrent rhythm.)

History of hypertension and either:

Documented history of SBP≥160 or DBP≥100, or;

Receiving ≥1 antihypertensive medication;

Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements

Exclusion Criteria

Long-standing persistent AF (\>12 months); \>3 prior atrial fibrillation ablations (lifetime); AF ablation within 3 months of enrollment; extensive scar in left atrium.

Individual with valvular AF or AF due to a reversible cause

Prior treatment with other devices for hypertension including but not limited to ROX Coupler, Mobius stent, and/or the CVRx barostimulator device.

NYHA class IV congestive heart failure;

Individual has renal artery anatomy that is ineligible for treatment (as determined by renal angiography);

Main renal artery diameter \<3mm or \>8.0 mm

Main renal treatable artery length \< 20 mm (length may include proximal branches)

Presence of renal artery stenosis of any origin ≥30%

Calcification in renal arteries

Prior renal denervation procedure

Presence of abnormal kidney tumors

Renal artery aneurysm

Pre-existing renal stent or history of renal artery angioplasty

Pre-existing aortic stent or history of aortic aneurysm

Fibromuscular disease of the renal arteries

Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter

Individual has an estimated glomerular filtration rate (eGFR) of less than 40mL/min/1.73m2, using the MDRD calculation;

Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)

Individual with known allergy to contrast medium not amendable to treatment.

Life expectancy \<1 year for any medical condition

Individual has experienced a myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit.

Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis.

Female participants who are pregnant or nursing.

Individual has known secondary hypertension.

Individual has a single functioning kidney (either congenitally or iatrogenically).

Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.

Patients concurrently enrolled in any other investigational drug or device trial that would interfere with the conduction of this protocol.

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 Charleston?

Yes, this clinical trial (NCT05988411) has an active research site in Charleston, SC 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 Atrial Fibrillation Treatment Options in Charleston, SC

If you're searching for paroxysmal atrial fibrillation treatment options in Charleston, SC, this clinical trial (NCT05988411) 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 Charleston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced paroxysmal atrial fibrillation 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 atrial fibrillation clinical trials near you to find additional studies recruiting in your area.

Paroxysmal Atrial Fibrillation Clinical Trial in Charleston, SC

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