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…
ID
Bron
Verkorte titel
Aandoening
- paroxysmal of persistent atrial fibrillation - hypertension
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary efficacy endpoint<br>
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.
<br><br>
Primary safety endpoint<br>
The occurrence of cardiovascular death, stroke, major access site bleeding, acute
kidney injury or renal artery stenosis at 6 months.
Doel van het onderzoek
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
Onderzoeksopzet
baseline vs. 3, 6, 12, 24 and 36 months postprocedure.
Onderzoeksproduct en/of interventie
Renal sympathetic denervation using the St Jude Medical EnligHTN system
Algemeen / deelnemers
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
Wetenschappers
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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);
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5181 |
| NTR-old | NTR5329 |
| CCMO | NL |