search
Back to results

ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients

Primary Purpose

Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Renal Denervation
Catheter Ablation
Sponsored by
Vivek Reddy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18; Planned for a redo AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as successful pulmonary vein isolation, if needed, as well as bidirectional block of any attempted anatomic lesion sets such as cavotricuspid isthmus line, roofline, mitral line and superior vena cava isolation, must have been completed). Note: the clinical recurrences must primarily be atrial fibrillation, and not atrial flutter/tachycardia (that is, a prospective patient may have a AFL/AT recurrences, but AF must be the dominant recurrent rhythm.) History of hypertension and either: Documented history of SBP≥160 or DBP≥100, or; Receiving ≥1 antihypertensive medication; Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements Exclusion Criteria: Long-standing persistent AF (>12 months); >3 prior atrial fibrillation ablations (lifetime); AF ablation within 3 months of enrollment; extensive scar in left atrium. Individual with valvular AF or AF due to a reversible cause Prior treatment with other devices for hypertension including but not limited to ROX Coupler, Mobius stent, and/or the CVRx barostimulator device. NYHA class IV congestive heart failure; Individual has renal artery anatomy that is ineligible for treatment (as determined by renal angiography); Main renal artery diameter <3mm or >8.0 mm Main renal treatable artery length < 20 mm (length may include proximal branches) Presence of renal artery stenosis of any origin ≥30% Calcification in renal arteries Prior renal denervation procedure Presence of abnormal kidney tumors Renal artery aneurysm Pre-existing renal stent or history of renal artery angioplasty Pre-existing aortic stent or history of aortic aneurysm Fibromuscular disease of the renal arteries Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter Individual has an estimated glomerular filtration rate (eGFR) of less than 40mL/min/1.73m2, using the MDRD calculation; Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation) Individual with known allergy to contrast medium not amendable to treatment. Life expectancy <1 year for any medical condition Individual has experienced a myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit. Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis. Female participants who are pregnant or nursing. Individual has known secondary hypertension. Individual has a single functioning kidney (either congenitally or iatrogenically). Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements. Patients concurrently enrolled in any other investigational drug or device trial that would interfere with the conduction of this protocol.

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Catheter ablation + renal denervation

Catheter ablation only

Arm Description

Catheter ablation + renal denervation

Catheter ablation

Outcomes

Primary Outcome Measures

Freedom from atrial arrhythmias with no AADs
Freedom from atrial arrhythmias (AT/AF/AFL) recurrence ≥ 30 seconds off all antiarrhythmic drug uses (AADs) (after the 90-day blanking period).

Secondary Outcome Measures

Freedom from atrial arrhythmias (AT/AF/AFL) with AADs
Freedom from AT/AF/AFL recurrence ≥ 30 seconds at 12 months (not including a 3-month blanking period) despite taking AADs
Procedure-related adverse events
Number of procedure-related adverse events
Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT)
Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT). Each item scored from 1-7, with total scale from 20-140, Lower score indicates better health outcomes.
Blood pressure
Blood pressure - Systolic and Diastolic
Number of AF episodes
AF burden assessed by the amount of AF episodes detected during Event Monitoring

Full Information

First Posted
August 4, 2023
Last Updated
September 6, 2023
Sponsor
Vivek Reddy
search

1. Study Identification

Unique Protocol Identification Number
NCT05988411
Brief Title
ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients
Official Title
Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation - Redo Ablation Procedures: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vivek Reddy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
This is a prospective, controlled, single-blind, randomized trial. The pilot study will be conducted in up to 20 clinical sites in the United States. Once the clinical sites are up and running (expected to take 6 months), accrual is expected to take an additional 9 months, and all patients will be followed for 12 months post randomization. Patients, the Clinical Events Committee and the ECG core lab will be blinded during the trial. Patients will be unblinded at the 12-month visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial.
Masking
Participant
Masking Description
single-blind
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Catheter ablation + renal denervation
Arm Type
Experimental
Arm Description
Catheter ablation + renal denervation
Arm Title
Catheter ablation only
Arm Type
Active Comparator
Arm Description
Catheter ablation
Intervention Type
Device
Intervention Name(s)
Renal Denervation
Intervention Description
Renal denervation using the Paradise renal denervation system - a dedicated Renal Denervation (RDN) catheter that delivers a circumferential ring of ablative ultrasound energy
Intervention Type
Device
Intervention Name(s)
Catheter Ablation
Intervention Description
Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation.
Primary Outcome Measure Information:
Title
Freedom from atrial arrhythmias with no AADs
Description
Freedom from atrial arrhythmias (AT/AF/AFL) recurrence ≥ 30 seconds off all antiarrhythmic drug uses (AADs) (after the 90-day blanking period).
Time Frame
after 90 days
Secondary Outcome Measure Information:
Title
Freedom from atrial arrhythmias (AT/AF/AFL) with AADs
Description
Freedom from AT/AF/AFL recurrence ≥ 30 seconds at 12 months (not including a 3-month blanking period) despite taking AADs
Time Frame
at 12 months
Title
Procedure-related adverse events
Description
Number of procedure-related adverse events
Time Frame
at 12 months
Title
Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT)
Description
Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT). Each item scored from 1-7, with total scale from 20-140, Lower score indicates better health outcomes.
Time Frame
at 12 months
Title
Blood pressure
Description
Blood pressure - Systolic and Diastolic
Time Frame
at 12 months
Title
Number of AF episodes
Description
AF burden assessed by the amount of AF episodes detected during Event Monitoring
Time Frame
at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18; Planned for a redo AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as successful pulmonary vein isolation, if needed, as well as bidirectional block of any attempted anatomic lesion sets such as cavotricuspid isthmus line, roofline, mitral line and superior vena cava isolation, must have been completed). Note: the clinical recurrences must primarily be atrial fibrillation, and not atrial flutter/tachycardia (that is, a prospective patient may have a AFL/AT recurrences, but AF must be the dominant recurrent rhythm.) History of hypertension and either: Documented history of SBP≥160 or DBP≥100, or; Receiving ≥1 antihypertensive medication; Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements Exclusion Criteria: Long-standing persistent AF (>12 months); >3 prior atrial fibrillation ablations (lifetime); AF ablation within 3 months of enrollment; extensive scar in left atrium. Individual with valvular AF or AF due to a reversible cause Prior treatment with other devices for hypertension including but not limited to ROX Coupler, Mobius stent, and/or the CVRx barostimulator device. NYHA class IV congestive heart failure; Individual has renal artery anatomy that is ineligible for treatment (as determined by renal angiography); Main renal artery diameter <3mm or >8.0 mm Main renal treatable artery length < 20 mm (length may include proximal branches) Presence of renal artery stenosis of any origin ≥30% Calcification in renal arteries Prior renal denervation procedure Presence of abnormal kidney tumors Renal artery aneurysm Pre-existing renal stent or history of renal artery angioplasty Pre-existing aortic stent or history of aortic aneurysm Fibromuscular disease of the renal arteries Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter Individual has an estimated glomerular filtration rate (eGFR) of less than 40mL/min/1.73m2, using the MDRD calculation; Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation) Individual with known allergy to contrast medium not amendable to treatment. Life expectancy <1 year for any medical condition Individual has experienced a myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit. Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis. Female participants who are pregnant or nursing. Individual has known secondary hypertension. Individual has a single functioning kidney (either congenitally or iatrogenically). Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements. Patients concurrently enrolled in any other investigational drug or device trial that would interfere with the conduction of this protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeff Lam, MS
Phone
(212) 824-8929
Email
jeff.lam@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Betsy Ellsworth, MSN ANP
Phone
(212) 824-8902
Email
betsy.ellsworth@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Reddy, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Lam, MS
Phone
212-824-8929
Email
jeff.lam@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Betsy Ellsworth, MSN ANP
Phone
(212) 824-8902
Email
betsy.ellsworth@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Abhishek Maan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients

We'll reach out to this number within 24 hrs