160 Participants Needed

Renal Denervation + AF Ablation for Atrial Fibrillation

(ULTRA-HFIB Trial)

Recruiting at 16 trial locations
SC
BE
CS
MK
JL
Overseen ByJeff Lam, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vivek Reddy
Must be taking: Antihypertensives
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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).

Who Is on the Research Team?

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

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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 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.
I have high blood pressure and am on medication for it.
See 1 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.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo AF ablation with or without renal sympathetic denervation

90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Catheter Ablation
  • Renal Denervation
Trial Overview 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.
How Is the Trial Designed?
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:
  • Symptomatic paroxysmal or persistent atrial fibrillation
  • Heart failure with reduced left ventricular fraction
🇺🇸
Approved in United States as Pulmonary Vein Isolation (PVI) for:
  • Symptomatic paroxysmal or persistent atrial fibrillation
  • Heart failure with reduced left ventricular fraction
🇨🇦
Approved in Canada as Pulmonary Vein Isolation (PVI) for:
  • Symptomatic paroxysmal or persistent atrial fibrillation
  • Heart failure with reduced left ventricular fraction

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vivek Reddy

Lead Sponsor

Trials
23
Recruited
5,700+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security