Renal Denervation for Atrial Fibrillation

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Vivek Reddy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Vivek Reddy

Must be taking: Antihypertensives

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

Stay on Your Current Meds

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial. The purpose of the study is to determine the role of adjunctive renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension scheduled for a redo AF ablation procedure for paroxysmal or persistent AF. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves patients with hypertension who are already on antihypertensive medication, it seems likely that you may continue your current medications.

What data supports the effectiveness of the treatment Renal Denervation for Atrial Fibrillation?

Research shows that Pulmonary Vein Isolation (PVI), a key part of catheter ablation, is effective in managing atrial fibrillation by helping restore and maintain a normal heart rhythm. This suggests that the treatment, which includes PVI, may be effective for atrial fibrillation. ^{1 2 3 4 5}

Is renal denervation safe for humans?

Pulmonary vein isolation (PVI), a type of catheter ablation, is generally considered safe, with severe complications occurring in 1-3% of patients. This suggests that similar procedures like renal denervation may also have a comparable safety profile. ^{1 3 5 6 7}

How does the treatment Catheter Ablation for Atrial Fibrillation differ from other treatments for this condition?

Catheter Ablation, specifically Pulmonary Vein Isolation (PVI), is unique because it targets the electrical signals in the heart by isolating the pulmonary veins, which is a cornerstone strategy for rhythm control in atrial fibrillation. Unlike medications, this treatment directly modifies the heart's electrical pathways to restore normal rhythm. ^{1 3 4 5 8}

Research Team

Vivek Reddy, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

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.

Inclusion Criteria

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

I am 18 years old or older.

Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements

Exclusion Criteria

You have used other devices for treating high blood pressure before, such as the ROX Coupler, Mobius stent, or the CVRx barostimulator device.

The main blood vessel in the kidney is less than 20 millimeters long and can be treated.

You are not expected to live for more than 1 year due to a medical condition.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either catheter ablation alone or catheter ablation with renal sympathetic denervation

Expected to take 6 months to set up clinical sites and 9 months for accrual

Follow-up

Participants are monitored for safety and effectiveness after treatment, including freedom from atrial arrhythmias and quality of life assessments

12 months

Treatment Details

Interventions

• Catheter Ablation (Procedure)
• Renal Denervation (Procedure)

Trial Overview 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.

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 Canada for the following indications:

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

Research Locations Nearby Select from list below to view details:

Arrhythmia Research Group Jonesboro, AR

UCSF San Francisco, CA

Los Robles Medical Center Thousand Oaks, CA

Henry Ford Health System Detroit, MI

More Trial Locations

Who Is Running the Clinical Trial?

Vivek Reddy

Lead Sponsor

Trials

23

Patients Recruited

5,700+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial results of using a novel irrigated multielectrode mapping and ablation catheter for pulmonary vein isolation. Shin, DI., Kirmanoglou, K., Eickholt, C., et al.[2016]

In a study of 486 patients with persistent and long-standing persistent atrial fibrillation (AF) treated with cryoballoon ablation, the procedure demonstrated a high acute success rate of 97.6% for pulmonary vein isolation (PVI).

The procedure was found to be safe, with a low complication rate of 4.3%, and showed reasonable mid-term success rates for freedom from AF, with 63.9% of patients remaining event-free at 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary vein isolation cryoablation for patients with persistent and long-standing persistent atrial fibrillation: Clinical outcomes from the real-world multicenter observational project. Tondo, C., Iacopino, S., Pieragnoli, P., et al.[2018]

The STOP Persistent AF trial showed that cryoballoon ablation is a safe and effective treatment for patients with drug-refractory persistent atrial fibrillation, achieving a 54.8% success rate in maintaining freedom from AF, AFL, or AT at 12 months.

With only one primary safety event reported (0.6% rate), the procedure demonstrated a favorable safety profile, alongside significant improvements in quality of life as measured by the AFEQT and SF-12 questionnaires.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial. Su, WW., Reddy, VY., Bhasin, K., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in atrial fibrillation ablation. Kim, JA., Khan, K., Kherallah, R., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of catheter ablation strategies for rhythm control in patients with atrial fibrillation: a meta-analysis. Assasi, N., Xie, F., Blackhouse, G., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications in pulmonary vein isolation in the Netherlands Heart Registration differ with sex and ablation technique. Mol, D., Houterman, S., Balt, JC., et al.[2021]

In a study of 58 patients undergoing pulmonary vein isolation (PVI) for atrial fibrillation, using a circular mapping catheter (CMC) inside the pulmonary vein during laser ablation was found to be feasible and safe, with no major complications reported in this group.

The mapping-guided approach led to a significant reduction in unsuccessfully isolated pulmonary veins after a learning curve, but both mapping-guided and standard techniques showed similar rates of atrial fibrillation-free survival after 16.7 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new circular mapping-guided approach for endoscopic laser balloon pulmonary vein isolation. Gal, P., Smit, JJJ., Adiyaman, A., et al.[2020]

In a study of 67 patients with atrial fibrillation (AF) treated with the PV ablation catheter (PVAC), 48.7% of patients with paroxysmal AF achieved sustained sinus rhythm without anti-arrhythmic drugs after a single procedure, indicating good efficacy for this group.

The procedure was found to be safe, but only 13.3% of patients with persistent AF achieved sustained sinus rhythm without medication, suggesting that PVAC may not be as effective for this type of AF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of multi-electrode duty-cycled radiofrequency ablation in patients with paroxysmal and persistent atrial fibrillation. Koźluk, E., Balsam, P., Peller, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Initial results of using a novel irrigated multielectrode mapping and ablation catheter for pulmonary vein isolation. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Pulmonary vein isolation cryoablation for patients with persistent and long-standing persistent atrial fibrillation: Clinical outcomes from the real-world multicenter observational project. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Innovations in atrial fibrillation ablation. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of catheter ablation strategies for rhythm control in patients with atrial fibrillation: a meta-analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Complications in pulmonary vein isolation in the Netherlands Heart Registration differ with sex and ablation technique. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

A new circular mapping-guided approach for endoscopic laser balloon pulmonary vein isolation. [2020]

8. Poland pubmed.ncbi.nlm.nih.gov

Efficacy of multi-electrode duty-cycled radiofrequency ablation in patients with paroxysmal and persistent atrial fibrillation. [2022]