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…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Health condition
Atrial fibrillation, hypertension
Research involving
Sponsors and support
Intervention
- Surigical procedure
Outcome measures
Primary outcome
Time to first detection of atrial fibrillation (AF) >30 seconds, with the monitoring period starting 3 months after the intervention.
Secondary outcome
AF burden after 12 months of follow-up, expressed in % of the monitoring period, in patients with continuous rhythm monitoring. The monitoring period starts 3 months after the intervention. Blood pressure at 3, 6, 12 months after the intervention, and change in blood pressure compared to measurement before the intervention
Blood pressure and heart rate response changes induced by exercise testing
Changes in heart rate variability measures tested by Holter monitoring compared to measurement before the intervention
Changes in arterial stiffness measures post intervention AASI (ambulatory arterial stiffness index) by ambulatory blood pressure monitoring, PWV (pulse wave velovity) and augmentation index compared to measurement before the intervention
Background summary
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
Study objective
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.,
Study design
3, 6 and 12 months
Intervention
Control group These patients will undergo PVI Interventional group These patients will undergo RDN and PVI
Gery de Jong
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)43 4262999
g.dejong@diagram-zwolle.nl
Gery de Jong
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)43 4262999
g.dejong@diagram-zwolle.nl
Age
Inclusion criteria
The patient falls within the target group resistent hypertension or symphatic overdrive
Patient is an acceptable candidate for renal denervation treatment
Patient <75 years
Exclusion criteria
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
Design
Recruitment
IPD sharing statement
Postzone P5-P, kamer P5-22
Postbus 9600
2300 RC Leiden
071 526 3241/ 071 526 6963
metc-ldd@lumc.nl
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 | NL3943 |
| NTR-old | NTR4109 |
| CCMO | NL.45174.075.13 |
| ClinicalTrials.gov | NCT02115100 |