We hypothesize that identification and localization of the sympathetic nerve bundles using 3D navigation systems and selective pacing manoeuvres will allow a functional approach to denervate the kidneys and improve the success rate of this…
ID
Bron
Verkorte titel
Aandoening
Patients with refractory hypertension and patients with combined hypertension and paroxysmal or persistent atrial fibrillation.
Patients who are accepted for renal denervation or combined pulmonary vein isolation and renal denervation according to routine clinical practice are eligible for this study.
Patiënten met refractaire hypertensie en patiënten met gecombineerde hypertensie en paroxysmale of aanhoudende atrim fibrileren.
Patiënten die worden geaccepteerd voor renale denervatie of gecombineerde longaderisolatie met renale denervatie volgens routine klinische praktijk en in aanmerking komen voor deze studie.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Main study parameter will be the arterial blood pressure response to renal nerve stimulation (RNS) prior to renal denervation (RDN) and absence of blood pressure rise in response to pacing in the renal artery after renal denervation (RDN).
Achtergrond van het onderzoek
Study design: Investigator initiated, single centre, feasibility study
Main objectives are twofold:
1. To investigate the feasibility of RNS in patients with therapy resistant hypertension, which is assessing the functional distribution of renal nerves using 3D imaging and differential pacing modalities.
2. To investigate the blood pressure responses and cardiac excitable properties to RNS, and subsequently perform a RDN procedure, guided by 3D mapping by two different techniques e.g. RNS-checked RDN and RNS-guided RDN procedures.
Study population: 40 patients (18 - 80 yr old)
Doel van het onderzoek
We hypothesize that identification and localization of the sympathetic nerve bundles using 3D navigation systems and selective pacing manoeuvres will allow a functional
approach to denervate the kidneys and improve the success rate of this procedure in patients with hypertension.
- We hypothesize that the renal nerve stimulation (RNS)-guided renal denervation (RDN) procedure will show better blood pressure data during follow up, since the completeness has been assessed in contrast to the RNS-checked RDN procedure.
Onderzoeksopzet
3,6,12 months outcome
Onderzoeksproduct en/of interventie
-RNS-checked RDN
- RNS-guided RDN
Publiek
Sonja Postma
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262999
s.postma@diagram-zwolle.nl
Wetenschappelijk
Sonja Postma
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262999
s.postma@diagram-zwolle.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Patients with refractory hypertension and patients with combined hypertension and paroxysmal or persistent atrial fibrillation.
- Age 18-80 years
- Glomerularfiltrationrate >45 mL/min
- No history of renal artery stenosis
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Type 1 diabetes mellitus
- Contraindication to chronic anticoagulation therapy or heparin.
- Primary pulmonary hypertension.
- Known secondary cause of hypertension
- Renal artery stenosis >50% of the arterial lumen, or renal artery lumen ¡Ü3 mm.
- Dual or triple ipsilateral renal artery ostia.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4239 |
| NTR-old | NTR4384 |
| CCMO | NL47172.075.13 |
| OMON | NL-OMON41331 |