Status:
TERMINATED
Renal Nerve Denervation After Pulmonary Vein Isolation for Persistent Atrial Fibrillation
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 cryoa...
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 ba...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
September 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03246568
Start Date
September 17 2018
End Date
August 31 2020
Last Update
October 26 2021
Active Locations (1)
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1
The Chinese University of Hong Kong
Hong Kong, Hong Kong