Renal Denervation + AF Ablation for Atrial Fibrillation
(ULTRA-HFIB Trial)

Recruiting in Palo Alto (17 mi)

+16 other locations

Vivek Reddy, MD - Physician's Channel ...

Overseen byVivek Reddy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vivek Reddy

Stay on Your Current Meds

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of Atrial Fibrillation (AF) recurrence in patients scheduled for an AF ablation procedure. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).

Eligibility Criteria

This trial is for adults over 18 with a history of high blood pressure and planned first-ever AF ablation procedure. They must be willing to follow the study plan and have controlled hypertension, either Stage III or on medication. Excluded are those with long-term persistent AF, severe heart failure, poor kidney function, known allergies to contrast media not treatable, pregnant or nursing women, single functioning kidney individuals, drug/alcohol dependency issues, concurrent enrollment in conflicting trials.

Inclusion Criteria

I am 18 years old or older.

I have a history of high blood pressure.

I am scheduled for my first AF ablation procedure and it must be completed successfully before I can join.

+2 more

Exclusion Criteria

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

I do not have a current drug or alcohol problem and can follow study instructions.

My AFib is caused by a heart valve issue or a temporary condition.

+15 more

Participant Groups

The ULTRA-HFIB Pilot aims to see if adding renal denervation (RDN) to standard atrial fibrillation (AF) ablation helps prevent AF from coming back. Participants will be randomly assigned to just get an AF ablation or both an AF ablation and RDN.

2Treatment groups

Experimental Treatment

Active Control

Group I: Catheter ablation + renal denervationExperimental Treatment2 Interventions

Catheter ablation + renal denervation

Group II: Catheter ablation onlyActive Control1 Intervention

Catheter ablation

Catheter Ablation is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Pulmonary Vein Isolation (PVI) for: