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Device

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

ULTRA-HFIB Trial 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.Check my eligibility
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.See study design
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.

ULTRA-HFIB Trial 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.

ULTRA-HFIB Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds
Secondary outcome measures
AF burden at 12 months
AF burden at 6 months
Change in office systolic blood pressure change from baseline to 12 months
+3 more

ULTRA-HFIB 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
~810

Find a Location

Who is running the clinical trial?

Vivek ReddyLead Sponsor
20 Previous Clinical Trials
5,196 Total Patients Enrolled
10 Trials studying Atrial Fibrillation
915 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
33 Previous Clinical Trials
12,438 Total Patients Enrolled
18 Trials studying Atrial Fibrillation
5,702 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.

Media Library

Catheter Ablation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04182620 — N/A
Atrial Fibrillation Research Study Groups: Catheter ablation + renal denervation, Catheter ablation only
Atrial Fibrillation Clinical Trial 2023: Catheter Ablation Highlights & Side Effects. Trial Name: NCT04182620 — N/A
Catheter Ablation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04182620 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple healthcare facilities in this city conducting the research project?

"This trial is being administrated at the Cleveland Clinic in Ohio, Mount Sinai Hospital in New york City and University of Arizona - Banner University Medical Center in Phoenix. In addition to these three medical centres, there are 10 other participating sites throughout the US."

Answered by AI

Are participants still being accepted for this medical experiment?

"As indicated by the clinicaltrials.gov database, this medical experiment is presently recruiting participants. It was initially made available on July 8th 2020, and its latest revision was done on April 11th 2022."

Answered by AI

What is the total enrollment for this medical study?

"To fulfill this clinical trial's requirements, 130 individuals who are eligible for participation must be recruited. Currently, recruitment is taking place in Cleveland Clinic located in Cleveland and Mount Sinai Hospital found in New york City."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Pacific Heart Institute
Cleveland Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~7 spots leftby Jun 2024