|- candidate number||22501|
|- NTR Number||NTR5329|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-jul-2015|
|- Secondary IDs||NL 47060.078.13|
|- Public Title||Atrial Fibrillation improvement by renal denervation|
|- Scientific Title||Atrial Fibrillation Reduction by Renal
|- ACRONYM||AFFORD Study|
|- hypothesis||Rationale: Hypertension is the most common cardiovascular condition responsible for the
development and maintenance of atrial fibrillation (AF). Treating drug-resistant hypertension
with renal denervation has been reported to control blood pressure, but any effect on AF is
Objective: The objective of the present pilot study is to assess whether
|- Healt Condition(s) or Problem(s) studied||Atrial Fibrillation, Hypertension|
|- 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
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||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);
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jul-2014|
|- planned closingdate||12-dec-2015|
|- Target number of participants||20|
|- Interventions||Renal sympathetic denervation using the St Jude Medical EnligHTN system|
|- Primary outcome||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 outcome||• 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.
|- Timepoints||baseline vs. 3, 6, 12, 24 and 36 months postprocedure.|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD Joost Daemen|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD Joost Daemen|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|St Jude Medical inc - Belgium|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||24-jul-2015 - 25-aug-2015|