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Ablation of Sympathetic Atrial Fibrillation


- candidate number15247
- NTR NumberNTR4109
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-aug-2013
- Secondary IDsNL.45174.075.13 ABR
- Public TitleAblation of Sympathetic Atrial Fibrillation
- Scientific TitleTreatment of atrial fibrillation in patients with high sympathetic activity by pulmonary vein isolation in combination with, renal artery denervation or pulmonary vein isolation only; an international randomized, controlled trial
- ACRONYMASAF
- hypothesisRenal artery denervation (RDN) on top of pulmonary vein isolation (PVI) will improve the success of ablative therapy for patients who have paroxysmal and/or persistent atrial fibrillation, with out of range hypertension (systolic >140 mmHg or >130/80 mmHg in diabetics and patients with chronic renal disease) or have signs of sympathetic overdrive.,
- Healt Condition(s) or Problem(s) studiedAtrial Fibrillation, High blood pressure
- Inclusion criteriaThe patient falls within the target group resistent hypertension or symphatic overdrive
Patient is an acceptable candidate for renal denervation treatment
Patient is > 65 year of age
- Exclusion criteriaContraindication to chronic anticoagulation therapy or heparin
Previous left heart ablation procedure for AF
Acute coronary syndrome, cardiac surgery, PCI or stroke within 3 months prior to enrolment
Renal artery stenosis >50% of the arterial lumen, or renal artery lumen >=3 mm
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2013
- planned closingdate1-dec-2019
- Target number of participants138
- InterventionsInterventional group 1
These patients will undergo renal artery denervation.
Control group 2
These patients will undergo pulmonary vein isolation.
Interventional group 3
These patients will undergo renal artery denervation and pulmonary vein isolation
- Primary outcomeTime to first detection of atrial fibrillation >30 seconds, with the monitoring period starting 3 months after the intervention
- Secondary outcomeAF burden after 12 months of follow-up, expressed in % of the monitoring period, in patients with continuous rhythm monitoring. The monitoring period starts 3 months after the intervention. Blood pressure at 3, 6, 12 months after the intervention, and change in blood pressure compared to measurement before the intervention
Blood pressure and heart rate response changes induced by exercise testing Changes in cardiac sympathetic innervation post intervention compared to measurement before intervention by MIBG in a subset of patients
Changes in heart rate variability measures tested by Holter monitoring compared to measurement before the intervention Changes in biomarkers post intervention representing sympathetic tone (blood cortisol and metanephrines, urinary cortisol and catecholamines) compared to before the intervention
Changes in arterial stiffness measures post intervention AASI (ambulatory arterial stiffness index) by ambulatory blood pressure monitoring, PWV (pulse wave velovity) and augmentation index compared to measurement before the intervention
- TimepointsTime to first detection of atrial fibrillation >30 seconds, with the monitoring period starting 3 months after the intervention AF burden after 12 months of follow-up, expressed in % of the monitoring period, in patients with continuous rhythm monitoring. The monitoring period starts 3 months after the intervention.
Blood pressure at 3, 6, 12 months after the intervention, and change in blood pressure compared to measurement before the intervention
Blood pressure and heart rate response changes induced by exercise testing
Changes in heart rate variability measures tested by Holter monitoring compared to measurement before the intervention
Changes in biomarkers post intervention representing sympathetic tone (blood cortisol and metanephrines, urinary cortisol and catecholamines) compared to before the intervention
Changes in arterial stiffness measures post intervention AASI (ambulatory arterial stiffness index) by ambulatory blood pressure monitoring, PWV (pulse wave velovity) and augmentation index compared to measurement before the intervention
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Sonja Postma
- CONTACT for SCIENTIFIC QUERIESDr. A. Elvan
- Sponsor/Initiator Isala Zwolle
- Funding
(Source(s) of Monetary or Material Support)
Medtronic B.V.
- PublicationsN/A
- Brief summaryThis is a prospective, randomized, controlled, muliti-center international clinical trial to assess if: - RDN in combination with PVI prevents AF in patients with out of range hypertension or signs of sympathetic overdrive.
- RDN in combination with PVI, is more successful in achieving long term sinus rhythm than PVI alone in patients with AF and out of range hypertension or signs of sympathetic overdrive.
138 patients will be included and randomized into one of the following groups:
1. These patients will undergo PVI
2. These patients wil undergo RND en PVI.
Follow-up will occur at 3 months, 6 months and 12 months
- Main changes (audit trail)22-mei-2016:

NEW interventions:
Control group
These patients will undergo PVI.
Interventional group
These patients will undergo RDN and PVI

NEW primary outcome:
Time to first detection of atrial fibrillation (AF) >30 seconds, with the monitoring period starting 3 months after the intervention

NEW secondary outcome:
- AF burden after 12 months of follow-up, expressed in % of the monitoring period, in patients with continuous rhythm monitoring. The monitoring period starts 3 months after the intervention.
- Blood pressure at 3, 6, 12 months after the intervention, and change in blood pressure compared to measurement before the intervention
- Blood pressure and heart rate response changes induced by exercise testing
- Changes in cardiac sympathetic innervation post intervention compared to measurement before intervention by MIBG in a subset of patients
- Changes in heart rate variability measures tested by Holter monitoring compared to measurement before the intervention
- Changes in arterial stiffness measures post intervention AASI (ambulatory arterial stiffness index) by ambulatory blood pressure monitoring, PWV (pulse wave velovity) and augmentation index compared to measurement before the intervention

NEW timepoints:
3,6 and 12 months

8-mrt-2017
NEW inclusion
-- patient <75 years

26-jun-2017
Deleted following timepoint: Changes in cardiac sympathetic innervation post intervention compared to measurement before intervention by MIBG in a subset of patients
- RECORD6-aug-2013 - 26-jun-2017


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