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Procedure

Renal Denervation for Atrial Fibrillation

N/A
Recruiting
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
History of hypertension with documented history of SBP≥160 or DBP≥100, or receiving ≥1 antihypertensive medication
Age ≥ 18
Must not have
Extensive scar in left atrium
Pre-existing aortic stent or history of aortic aneurysm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how blocking nerves in the kidneys can help reduce recurrence of an irregular heart rhythm (Atrial Fibrillation) in people with high blood pressure.

Who is the study for?
This trial is for adults over 18 with a history of hypertension and atrial fibrillation, who have had a successful AF ablation before and are scheduled for another. They must be willing to follow the study's rules and attend all follow-ups. People can't join if they've had an AF ablation recently, severe heart failure, certain kidney issues or artery problems, drug/alcohol dependency, other device treatments for hypertension, or inflammatory bowel disease.
What is being tested?
The ULTRA-HFIB-Redo trial is testing whether adding renal sympathetic denervation to the usual catheter ablation treatment helps prevent atrial fibrillation from coming back in patients with high blood pressure. Participants will either receive just the catheter ablation (control) or both procedures (intervention), assigned randomly at a ratio of two intervention participants to one control.
What are the potential side effects?
Possible side effects include discomfort at the site where catheters enter the body, bleeding or bruising there too; damage to blood vessels; adverse reactions to contrast dye used during procedures; worsening kidney function; and risks associated with sedation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have high blood pressure or am on medication for it.
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I am 18 years old or older.
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I am scheduled for another AF ablation after a successful first procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have significant scarring in the left side of my heart.
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I have a stent in my aorta or a history of an aortic aneurysm.
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I have a condition affecting the muscles of my kidney arteries.
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I cannot have the Paradise Catheter due to narrowed arteries in my hip or thigh.
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I have severe heart failure.
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My main renal artery is either less than 3mm or more than 8mm in diameter.
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I have a narrowing of the arteries to my kidneys of 30% or more.
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I have a bulge in the artery that supplies blood to my kidney.
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I have only one working kidney.
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My high blood pressure is caused by another health condition.
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My kidney's blood vessels are not suitable for treatment.
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I have a renal stent or had a procedure to open my kidney arteries.
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I have a long-term inflammatory bowel condition like Crohn's disease or ulcerative colitis.
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I have abnormal tumors in my kidneys.
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I have undergone a kidney nerve ablation procedure.
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My atrial fibrillation is due to a heart valve issue or a temporary cause.
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I cannot have a procedure to treat irregular heartbeats using catheters.
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I have had atrial fibrillation for more than a year.
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I have had more than 3 procedures to correct heart rhythm problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 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
Freedom from atrial arrhythmias with no AADs
Secondary study objectives
Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT)
Blood pressure
Freedom from atrial arrhythmias (AT/AF/AFL) with AADs
+2 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
Catheter Ablation
2016
Completed Phase 4
~3920
Renal Denervation
2013
Completed Early Phase 1
~360

Find a Location

Who is running the clinical trial?

Vivek ReddyLead Sponsor
20 Previous Clinical Trials
5,147 Total Patients Enrolled
10 Trials studying Atrial Fibrillation
866 Patients Enrolled for Atrial Fibrillation
Vivek Reddy, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
35 Previous Clinical Trials
12,770 Total Patients Enrolled
19 Trials studying Atrial Fibrillation
7,316 Patients Enrolled for Atrial Fibrillation

Media Library

Catheter Ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05988411 — N/A
Atrial Fibrillation Research Study Groups: Catheter ablation only, Catheter ablation + renal denervation
Atrial Fibrillation Clinical Trial 2023: Catheter Ablation Highlights & Side Effects. Trial Name: NCT05988411 — N/A
Catheter Ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05988411 — N/A
~167 spots leftby Dec 2027
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