RECRUITING

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

Conditions

Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Ultrasound-Based Renal Sympathetic Denervation As Adjunctive Upstream Therapy During Atrial Fibrillation - Redo Ablation Procedures: a Pilot Study

Quick Facts

Study Start:2023-12-07

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05988411

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Jeff Lam, MS

CONTACT

(212) 824-8929

jeff.lam@mountsinai.org

Betsy Ellsworth, MSN ANP

CONTACT

(212) 824-8902

betsy.ellsworth@mountsinai.org

Principal Investigator

Vivek Reddy, MD

PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Study Locations (Sites)

Arrhythmia Research Group

Jonesboro, Arkansas, 72401

United States

UCSF

San Francisco, California, 94143

United States

Los Robles Medical Center

Thousand Oaks, California, 91360

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Trident Medical Center

Charleston, South Carolina, 29406

United States

Christus

Tyler, Texas, 75702

United States

Virginia Commonwealth University

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: Vivek Reddy

Vivek Reddy, MD, PRINCIPAL_INVESTIGATOR, MOUNT SINAI HOSPITAL

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-07

Study Completion Date2027-12

Study Record Updates

Study Start Date2023-12-07

Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation