Renal artery denervation (RDN) on top of pulmonary vein isolation (PVI) will improve the success of ablative therapy for patients who have paroxysmal and/or persistent atrial fibrillation, with out of range hypertension (systolic >140…
ID
Bron
Verkorte titel
Aandoening
- Hartritmestoornissen
Aandoening
Atrial fibrillation, hypertension
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
- Chirurgische ingreep
Uitkomstmaten
Primaire uitkomstmaten
Time to first detection of atrial fibrillation (AF) >30 seconds, with the monitoring period starting 3 months after the intervention.
Achtergrond van het onderzoek
This is a prospective, randomized, controlled,
muliti-center international clinical trial to assess if:
- RDN in combination with PVI prevents AF in
patients with out of range hypertension or signs of
sympathetic overdrive.
- RDN in combination with PVI, is more successful
in achieving long term sinus rhythm than PVI alone
in patients with AF and out of range hypertension or
signs of sympathetic overdrive.
138 patients will be included and randomized
into one of the following groups:
1. These patients will undergo PVI
2. These patients wil undergo RND en PVI.
Follow-up will occur at 3 months, 6 months and 12
months
Doel van het onderzoek
Renal artery denervation (RDN) on top of
pulmonary vein isolation (PVI) will improve the
success of ablative therapy for patients who have
paroxysmal and/or persistent atrial fibrillation, with
out of range hypertension (systolic >140 mmHg or
>130/80 mmHg in diabetics and patients with
chronic renal disease) or have signs of sympathetic
overdrive.,
Onderzoeksopzet
3, 6 and 12 months
Onderzoeksproduct en/of interventie
Control group
These patients will undergo PVI
Interventional group
These patients will undergo RDN and PVI
Publiek
Gery de Jong
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)43 4262999
g.dejong@diagram-zwolle.nl
Wetenschappelijk
Gery de Jong
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)43 4262999
g.dejong@diagram-zwolle.nl
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
The patient falls within the target group resistent hypertension or symphatic overdrive
Patient is an acceptable candidate for renal denervation treatment
Patient <75 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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 >=3 mm
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Postzone P5-P, kamer P5-22
Postbus 9600
2300 RC Leiden
071 526 3241/ 071 526 6963
metc-ldd@lumc.nl
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3943 |
| NTR-old | NTR4109 |
| CCMO | NL.45174.075.13 |
| ClinicalTrials.gov | NCT02115100 |