Atrial Fibrillation Reduction by Renal Sympathetic Denervation

Atrial Fibrillation Reduction by Renal Sympathetic Denervation - AFFORD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40581

Enrollment

Registered

2014-06-04

Start date

2014-08-15

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

atrial fibrillation

Interventions

A St. Jude Medical Confirm ICM will be implanted 3 months before the renal denervation to continuously monitor heart rate and rhythm during the entire pre-procedural (baseline) and 3 year follow-up

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. 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 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
To assess whether renal sympathetic denervation will decrease AF burden in patients with symptomatic paroxysmal or persistent AF at 6 months post procedure.	—

Secondary

Measure	Time frame
Primary safety endpoint The occurrence of cardiovascular death, stroke, major access site bleeding, acute kidney injury or renal artery stenosis at 6 months. Secondary endpoints • To evaluate the change in office based and 24h ambulatory blood pressure at 3, 6 and 12 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 volumes and dimensions • Change in left ventricular diastolic function • The occurrence of stroke	—

Measure

Time frame

Primary safety endpoint The occurrence of cardiovascular death, stroke, major access site bleeding, acute kidney injury or renal artery stenosis at 6 months. Secondary endpoints • To evaluate the change in office based and 24h ambulatory blood pressure at 3, 6 and 12 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 volumes and dimensions • Change in left ventricular diastolic function • The occurrence of stroke

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)