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Atrial Fibrillation improvement by renal denervation


- candidate number22501
- NTR NumberNTR5329
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jul-2015
- Secondary IDsNL 47060.078.13
- Public TitleAtrial Fibrillation improvement by renal denervation
- Scientific TitleAtrial Fibrillation Reduction by Renal Sympathetic Denervation
- ACRONYMAFFORD Study
- hypothesisRationale: 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 unknown.
Objective: The objective of the present pilot study is to assess whether
- Healt Condition(s) or Problem(s) studiedAtrial Fibrillation, Hypertension
- Inclusion criteria1. Age 18 years;
2. Symptomatic paroxysmal or persistent AF;
3. Systolic blood pressure of 140 mmHg or more despite the use of 2 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2014
- planned closingdate12-dec-2015
- Target number of participants20
- InterventionsRenal sympathetic denervation using the St Jude Medical EnligHTN system
- Primary outcomePrimary 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.
- Timepointsbaseline vs. 3, 6, 12, 24 and 36 months postprocedure.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD Joost Daemen
- CONTACT for SCIENTIFIC QUERIESMD, PhD Joost Daemen
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
St Jude Medical inc - Belgium
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD24-jul-2015 - 25-aug-2015


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