Renal Denervation + AF Ablation for Atrial Fibrillation

(ULTRA-HFIB Trial)

Recruiting at 16 trial locations

Overseen By Jeff Lam, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vivek Reddy

Must be taking: Antihypertensives

Disqualifiers: Long-standing AF, NYHA Class IV, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 90 days

160 Participants Needed

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).

Research Team

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

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 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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Catheter ablation + renal denervation Experimental Treatment 2 Interventions

Catheter ablation + renal denervation

Group II: Catheter ablation only Active Control 1 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

Who Is Running the Clinical Trial?

Vivek Reddy

Lead Sponsor

Trials

23

Recruited

5,700+