No registrations found.
ID
Source
Brief title
Health condition
- paroxysmal of persistent atrial fibrillation - hypertension
Sponsors and support
Intervention
Outcome measures
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.
Study objective
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
unknown.
Objective: The objective of the present pilot study is to assess whether
Study design
baseline vs. 3, 6, 12, 24 and 36 months postprocedure.
Intervention
Renal sympathetic denervation using the St Jude Medical EnligHTN system
Joost Daemen
office Ad-342, 's Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 703 56 65/+31 6 205 972 54
Email j.daemen@erasmusmc.nl
Joost Daemen
office Ad-342, 's Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 703 56 65/+31 6 205 972 54
Email j.daemen@erasmusmc.nl
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
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5181 |
| NTR-old | NTR5329 |
| CCMO | NL |