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Treatment of atrial fibrillation in patients with high sympathetic activity by pulmonary vein isolation in combination with renal denervation or pulmonary vein isolation only; an international randomized, controlled trial.

Treatment of atrial fibrillation in patients with high sympathetic activity by pulmonary vein isolation in combination with renal denervation or pulmonary vein isolation only; an international randomized, controlled trial. - ASAF trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47122
Enrollment
100
Registered
2013-08-26
Start date
2014-03-18
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Hypertensie en signalen van sympathische overactiviteit Atrial fibrillation hypertension

Interventions

The study population consists of patients with paroxysmal or persistent AF with out of range hypertension or signs of sympathetic overdrive. Patients will be randomized into two groups: Group 1: RDN

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The patient falls within the target group resistent hypertension or sympathic overdrive Patient is an acceptable candidate for renal denervation treatment Patient is

Exclusion criteria

Exclusion criteria: Contraindication 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

Design outcomes

Primary

MeasureTime frame
Time to first detection of atrial fibrillation >30 seconds, with the monitoring period starting 3 months after the intervention.

Secondary

MeasureTime frame
- 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 arterial stiffness measures post intervention AASI (ambulatory arterial stiffness index) by ambulatory blood pressure monitoring, PWV (pulse wave velocity) and augmentation index compared to measurement before the intervention

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)