Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-07 @ 9:02 AM
Study NCT ID:
NCT03246568
Status:
TERMINATED
Last Update Posted:
2021-10-26
First Post:
2017-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Nerve Denervation After Pulmonary Vein Isolation for Persistent Atrial Fibrillation
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
Official Title:
Renal Artery Sympathetic Denervation by Catheter Ablation After Pulmonary Vein Isolation for Persistent Atrial Fibrillation
Status:
TERMINATED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no funding to purchase study device
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Atrial fibrillation (AF) is the most common arrhythmia and it is associated with significant morbidity and mortality. Electrical isolation of the pulmonary vein (PVI) by radiofrequency energy or cryoablation has been shown to be an effective treatment of AF by reducing morbidity, improving quality of life and functional capacity.
Renal artery sympathetic denervation (RND) by catheter ablation has been shown in a preliminary study to improve outcome of PVI in patients with paroxysmal and/or persistent AF with concomitant refractory or moderate hypertension. In patients with renal impairment, RND also conferred benefit in reducing AF recurrence after PVI. The initial indication for catheter-based RND is for blood pressure control in patients with resistant hypertension. However, a recent study failed to show significant difference in blood pressure reduction by RND. Therefore, the effect of RND on AF suppression may be independent of blood pressure control. Possible mechanisms of RND on AF may include risk factors modification and anti-arrhythmic effect.
Renal artery sympathetic denervation (RND) by catheter ablation has been shown in a preliminary study to improve outcome of PVI in patients with paroxysmal and/or persistent AF with concomitant refractory or moderate hypertension. In patients with renal impairment, RND also conferred benefit in reducing AF recurrence after PVI. The initial indication for catheter-based RND is for blood pressure control in patients with resistant hypertension. However, a recent study failed to show significant difference in blood pressure reduction by RND. Therefore, the effect of RND on AF suppression may be independent of blood pressure control. Possible mechanisms of RND on AF may include risk factors modification and anti-arrhythmic effect.
Detailed Description:
This prospective randomized study aimed to evaluate the effect of RDN added to PVI for persistent AF. Study will be performed in accordance with Declaration of Helsinki.
Study Hypothesis: Catheter based RDN can prevent recurrence of AF in patient with persistent AF undergoing PVI by mechanism not related to hypertension control.
Primary outcome measure: Freedom from documented AF episodes post PVI as defined by longer than 30 seconds of AF recorded by implantable loop recorder 2 to 18 months after procedure with or without antiarrhythmic medication.
Sample Size:
This is an exploratory study, the sample size calculation will not be applied and arbitrary assign 20 subjects to each arm will be adopted.
Randomization Arms:
Patients are randomized in 1:1 fraction to one of the following arms:
1. PVI by cryo-balloon ablation without linear ablation;
2. PVI by cryo-balloon ablation without linear ablation plus bilateral RND using a multi-electrode renal denervation catheter.
Study Hypothesis: Catheter based RDN can prevent recurrence of AF in patient with persistent AF undergoing PVI by mechanism not related to hypertension control.
Primary outcome measure: Freedom from documented AF episodes post PVI as defined by longer than 30 seconds of AF recorded by implantable loop recorder 2 to 18 months after procedure with or without antiarrhythmic medication.
Sample Size:
This is an exploratory study, the sample size calculation will not be applied and arbitrary assign 20 subjects to each arm will be adopted.
Randomization Arms:
Patients are randomized in 1:1 fraction to one of the following arms:
1. PVI by cryo-balloon ablation without linear ablation;
2. PVI by cryo-balloon ablation without linear ablation plus bilateral RND using a multi-electrode renal denervation catheter.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: