Atrial Fibrillation improvement by renal denervation

Atrial Fibrillation Reduction by Renal Sympathetic Denervation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26212

Enrollment

Registered

2015-07-24

Start date

2014-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Renal sympathetic denervation using the St Jude Medical EnligHTN system

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age ¡Ý18 years; 2. Symptomatic paroxysmal or persistent AF; 3. Systolic blood pressure of 140 mmHg or more despite the use of ¡Ý2 antihypertensive drugs; 4. A glomerular filtration rate of 45ml/min/1.73m2 or more; 5. Written informed consent; 6. The patient agrees to the follow-up including the implantation of the ICM.

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. Renal artery abnormalities; 3. First episode of AF; 4. Long-term persistent or permanent AF 5. The patient has other medical illness (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than one year);

Design outcomes

Primary

Measure	Time frame
Primary efficacy endpoint To assess whether renal sympathetic denervation will decrease AF burden (min/day) in patients with symptomatic paroxysmal or persistent AF at 6 months post procedure. Primary safety endpoint The occurrence of cardiovascular death, stroke, major access site bleeding, acute kidney injury or renal artery stenosis at 6 months.	—

Secondary

Measure	Time frame
• To evaluate the change in office based and 24h ambulatory blood pressure at baseline vs. 3, 6 and 12, 24 and 36 months post procedure. • To assess quality of live using the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire pre- and 3, 6 and 12 months post procedure. • Newly acquired renal artery stenosis and/or repeat renal artery intervention. • Need for electrical cardioversion • Change in left ventricular and atrial volumes and dimensions at baseline vs. 3, 6, 12, 24 and 36 months post-procedure. • Change in left ventricular diastolic function at baseline vs. 3, 6, 12, 24 and 36 months post-procedure. • The occurrence of stroke at baseline vs. 3, 6, 12, 24 and 36 months postprocedure.	—

Measure

Time frame

• To evaluate the change in office based and 24h ambulatory blood pressure at baseline vs. 3, 6 and 12, 24 and 36 months post procedure. • To assess quality of live using the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire pre- and 3, 6 and 12 months post procedure. • Newly acquired renal artery stenosis and/or repeat renal artery intervention. • Need for electrical cardioversion • Change in left ventricular and atrial volumes and dimensions at baseline vs. 3, 6, 12, 24 and 36 months post-procedure. • Change in left ventricular diastolic function at baseline vs. 3, 6, 12, 24 and 36 months post-procedure. • The occurrence of stroke at baseline vs. 3, 6, 12, 24 and 36 months postprocedure.

—

Contacts

Public ContactJoost Daemen

P.O. Box 2040, 3000 CA Rotterdam, The Netherlands, internal postal address Ba-593

Email j.daemen@erasmusmc.nl+31 10 703 56 65/+31 6 205 972 54

Outcome results