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Atrial FibrillationNCT03246568

Renal Nerve Denervation After Pulmonary Vein Isolation for Persistent Atrial Fibrillation

A study testing Renal Nerve Denervation and Pulmonary vein isolation in people with Atrial Fibrillation, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Renal Nerve Denervation and Pulmonary vein isolation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteHong Kong
Study dates
17 Sep 2018to 31 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 17Show fewer
  • 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;
  • Patient with contraindication to left ventricle catheterization by a retrograde aortic approach (eg mechanical aortic valve, severe aortic stenosis and aortic dissection).
  • Patient with systolic blood pressure <100mmHg.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The Chinese University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Renal Artery Sympathetic Denervation by Catheter Ablation After Pulmonary Vein Isolation for Persistent Atrial Fibrillation

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.

Read the 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.
Being tested
Renal Nerve Denervation, Pulmonary vein isolation
Keywords
Ablation, Renal Denervation, Cryoballoon
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Renal Nerve DenervationProcedure or surgery

    Also called Renal artery sympathetic nerve denervation, RND

    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.

  • Pulmonary vein isolationProcedure or surgery

    Also called PVI

    PVI by cryo-balloon ablation without linear ablation

Study groups in NCT03246568
Study groupRoleWhat they receive
Pulmonary vein isolation aloneActive comparatorPVI by cryo-balloon ablation without linear ablation
Receives: Procedure: Pulmonary vein isolation
Renal nerve denervationExperimentalPVI by cryo-balloon ablation without linear ablation plus bilateral RND using a multi-electrode renal denervation catheter.
Receives: Procedure: Renal Nerve Denervation; Procedure: Pulmonary vein isolation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 to 18 months after procedure

Secondary outcomes (9)

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

    Freedom from documented atrial arrhythmia episodes post PVI as defined by longer than 30 seconds of atrial arrhythmia recorded by implantable loop recorder 2 to 18 months after procedure with or without antiarrhythmic medication.

    Measured: 2 to 18 months after procedure

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

    Freedom from symptomatic 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.

    Measured: 2 to 18 months after procedure

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

    Freedom from symptomatic atrial arrhythmia episodes post PVI as defined by longer than 30 seconds of atrial arrhythmia recorded by implantable loop recorder 2 to 18 months after procedure with or without antiarrhythmic medication.

    Measured: 2 to 18 months after procedure

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

    Freedom from documented AF episodes post PVI as defined by 30 seconds of AF recorded by hand-held smartphone device (i.e. Cardiio Rhythm iPhone AF-detection system or AliveCor single-lead ECG device) 2 to 18 months after procedure with or without antiarrhythmic medication.

    Measured: 2 to 18 months after procedure

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

    The mean blood pressure as measured by 24-hour ambulatory blood pressure before and after ablation up to 36 months.

    Measured: 18 months

  6. Incidence of peri-procedural complications.

    Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, phrenic nerve palsy, esophageal injury and death.

    Measured: 18 months

  7. Procedure duration

    Procedure duration

    Measured: duing procedure

  8. Fluoroscopy time during procedure

    Fluoroscopy time during procedure

    Measured: dueing procedure

  9. Number of repeat procedures

    Number of repeat procedures

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2017
  2. Study start17 Sep 2018
  3. Primary completion31 Aug 2020
  4. Study completion31 Aug 2020

Why it stopped: no funding to purchase study device

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03246568
Sponsor's protocol ID
CUHK-CARD-2017-RND
Status last verified
Oct 2021
First submitted
9 Aug 2017
Last updated
26 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Renal Nerve Denervation and Pulmonary vein isolation in people with Atrial Fibrillation, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: no funding to purchase study device). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from documented AF episodes post PVI by implantable loop recorder by implantable loop recorder. (time frame: 2 to 18 months after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03246568.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021; AzTrials last refreshed its copy on 1 Nov 2026.

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