Renal Nerve Denervation After Pulmonary Vein Isolation for Persistent Atrial Fibrillation

NCT03246568 | Terminated

• 1 other identifier: CUHK-CARD-2017-RND
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Ablation; Renal Denervation; Cryoballoon

Outcome Measures

Primary Outcomes (1)

• Freedom from documented AF episodes post PVI by implantable loop recorder by implantable loop recorder.

  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.

  2 to 18 months after procedure

Secondary Outcomes (9)

• Freedom from documented atrial arrhythmia episodes post PVI by implantable loop recorder.

  2 to 18 months after procedure

• Freedom from symptomatic AF episodes post PVI by implantable loop recorder.

  2 to 18 months after procedure

• Freedom from symptomatic atrial arrhythmia episodes post PVI by implantable loop recorder.

  2 to 18 months after procedure

• Freedom from documented AF episodes post PVI by hand-held smartphone device.

  2 to 18 months after procedure

• The mean blood pressure as measured by 24-hour ambulatory blood pressure monitoring.

  18 months

Study Arms (2)

Pulmonary vein isolation alone

ACTIVE COMPARATOR

PVI by cryo-balloon ablation without linear ablation

Procedure: Pulmonary vein isolation

Renal nerve denervation

EXPERIMENTAL

PVI by cryo-balloon ablation without linear ablation plus bilateral RND using a multi-electrode renal denervation catheter.

Procedure: Renal Nerve Denervation; Procedure: Pulmonary vein isolation

Interventions

Renal Nerve Denervation PROCEDURE

Bilateral renal denervation using a multi-polar radiofrequency ablation catheter (Symplicity™ Spyral Cather, Medtronic) in the right and left main, branch, and accessory renal arteries in vessels ranging in diameter between 3 and 8 mm.

Also known as: Renal artery sympathetic nerve denervation, RND

Renal nerve denervation

Pulmonary vein isolation PROCEDURE

PVI by cryo-balloon ablation without linear ablation

Also known as: PVI

Pulmonary vein isolation alone; Renal nerve denervation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age is 18 years or greater;
• Patients undergoing a first-time ablation procedure for AF;
• Patients with persistent AF;
• Persistent AF will be defined as a sustained episode lasting \> 7 days and less than 3 years.
• Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication;
• Symptomatic patients are those who have been aware of their AF at any time within the last 5 years prior to enrollment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
• At least one episode of persistent AF must have been documented by ECG, Holter, loop recorder, telemetry, trans telephonic monitoring (TTM), or implantable device within last 2 years of enrollment in this investigation.

You may not qualify if:

• Patients with paroxysmal AF;
• Paroxysmal AF will be defined as a sustained episode lasting \< 7 days.
• Patients with long-standing persistent AF;
• Long-standing persistent AF will be defined as a sustained episode lasting more than 3 years;
• Patients for whom cardioversion or sinus rhythm will never be attempted/pursued;
• Patients with AF felt to be secondary to an obvious reversible cause;
• Patients with contraindications to systemic anticoagulation with heparin or warfarin or a direct thrombin inhibitor;
• Patients with left atrial size ≥ 60 mm (2D echocardiography, parasternal long axis view);
• Patients with more than 50% renal artery stenosis identified by duplex ultrasound or renal angiogram;
• Patients in whom a renal stent has been in place for less than3 months;
• Patients with prior renal artery stent placement, the artery segment beyond the stent margins must be able to accommodate treatments;
• Patients with the treatment zone for denervation in the renal artery have areas of atheroma, severe fibromuscular dysplasia, calcification, and aneurysm that cannot be avoided;
• Patients with renal dysfunction as demonstrated by an estimated glomerular filtration rate less than 45 mL/min per 1.73 m2 are excluded from both studies;
• Pregnant women;
• Participation in another interventional study;

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bryan Ping Yen YAN

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Research on the Basis of Earlier Theory Renal artery sympathetic denervation (RND) by catheter ablation has been shown in a preliminary study to improve outcome of electrical isolation of the pulmonary vein (PVI) in patients with paroxysmal and/or persistent AF with concomitant refractory hypertension and the same group later showed renal sympathetic denervation improved outcome of PVI in the cohort of paroxysmal and/or persistent AF patients with 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. Early data from clinical trials without sham controls was promising - demonstrating large blood pressure reductions in patients with treatment-resistant hypertension.

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 11, 2017
• Study Start: September 17, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)