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

N/A

Waitlist Available

Led By Vivek Reddy, MD

Research Sponsored by Vivek Reddy

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18

Planned for a first-ever AF ablation procedure (paroxysmal or persistent) with technically successful AF ablation procedure completed prior to randomization

Must not have

Individual with valvular AF or AF due to a reversible cause

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding a renal sympathetic denervation procedure to standard AF ablation can help prevent AF recurrence.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to catheter insertion such as bleeding or bruising at the site of entry, damage to blood vessels near the kidneys during RDN treatment; however specific side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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I have high blood pressure and am on medication for it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have only one working kidney.

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I have had atrial fibrillation for more than a year.

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I have had a procedure to correct heart rhythm problems before.

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I cannot have AF catheter ablation due to a heart clot or issues with blood thinners.

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I am not pregnant or nursing.

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My kidney function is reduced, with an eGFR below 40.

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I have severe heart failure.

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I have high blood pressure caused by another health condition.

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I have a chronic condition like Crohn's disease or ulcerative colitis.

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My kidney's blood vessels are not suitable for the treatment based on an angiography.

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I have had surgery on the left side of my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds

Secondary study objectives

AF burden at 12 months

AF burden at 6 months

Change in office systolic blood pressure change from baseline to 12 months

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

renal denervation

2011

N/A

~60

Catheter ablation

2016

Completed Phase 4

~1260

0 / 15Eligibility criteria met

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Who is running the clinical trial?

Vivek ReddyLead Sponsor

20 Previous Clinical Trials

5,187 Total Patients Enrolled

10 Trials studying Atrial Fibrillation

906 Patients Enrolled for Atrial Fibrillation

Vivek Reddy, MD3.816 ReviewsPrincipal Investigator - Icahn School of Medicine at Mount Sinai

Icahn School of Medicine at Mount Sinai

34 Previous Clinical Trials

12,984 Total Patients Enrolled

19 Trials studying Atrial Fibrillation

7,550 Patients Enrolled for Atrial Fibrillation

5Patient Review

I had a great experience with Dr. Reddy. Not only did he attend to all of my medical concerns, but he also was able to fix my A Fib. I'm very grateful.