Treatment of Atrial Fibrillation in Patients by Pulmonary Vein Isolation in Combination With Renal Denervation or Pulmonary Vein Isolation Only

Study Purpose

Prospective, randomized, controlled, multicenter, international clinical trial. The study population consist of patients with paroxysmal or persistent atrial fibrillation with out range hypertension or signs of sympathetic overdrive. Patient will be randomized into one of the following two groups. group 1 : patients will undergo pulmonary vein isolation, group 2: Patients will undergo pulmonary vein isolation and renal artery denervation.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. The patient is willing and able to comply with the protocol and has provided written informed consent. 2. The patient falls within the target group resistant hypertension or sympathetic overdrive. 3. Patient is an acceptable candidate for renal denervation treatment. 4. Patient is < 65 year of age.

Exclusion Criteria:

1. Documented left atrial diameter on trans thoracic echocardiography (PLAX > 4.5 cm). 2. Contraindication to chronic anticoagulation therapy or heparin. 3. Previous left heart ablation procedure for AF (atrial fibrillation). 4. Acute coronary syndrome, cardiac surgery, PCI (percutaneous coronary intervention)or stroke within 3 months prior to enrollment. 5. Untreated hypothyroidism or hyperthyroidism. 6. More than grade 1/3 valvular regurgitation and/or significant valve stenosis (modest or severe). 7. LVEF (Left ventricular function) <45% and/or grade 3/4 diastolic dysfunction. 8. Enrollment in another investigational drug or device study. 9. Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age. 10. Mental or physical inability to participate in the study. 11. Planned cardiovascular intervention. 12. Life expectancy ≤ 12 months. 13. Renal artery stenosis >50% of the arterial lumen, or renal artery lumen. ≤3 mm. 14. Dual or triple ipsilateral renal artery ostia. 15. Obvious secondary cause of hypertension.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02115100
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Diagram B.V.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Arif Elvan, MD, PhD
Principal Investigator Affiliation	Maatschap Cardiologie Isala
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Netherlands, Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Out of Range Hypertension, Signs of Sympathetic Overdrive

Additional Details

The target group of patients are subjects ages <65 years, with paroxysmal or persistent atrial fibrillation, who have out of range hypertension (systolic >140 mmHg or >130/80 mmHg in diabetics and patients with chronic renal disease) or signs of sympathetic overdrive. Patients should use at least 2 anti-hypertensive's or should be intolerant for antihypertensive medication. Atrial fibrillation terminology: If atrial fibrillation recurs more than once but terminates spontaneously within seven days, the term paroxysmal AF is used. This is also used when the episode is less than 48 hours in duration and is terminated with electrical or pharmacological cardioversion. Persistent AF is defined as recurrent AF that is sustained for more than seven days. A patient that is electrically or pharmacologically cardioverted after more than two days is also diagnosed with persistent AF. After the exclusion of apparent secondary causes of hypertension, patients will be randomized to one of the following interventional treatments: First arm: PVI (69 patients) Second arm: PVI + RDN (69 patients) The patient will be treated under conscious sedation or general anesthesia. The control group will consist of patients who undergo PVI alone. The study will be a randomized, controlled trial. The follow up period will be up to one year after the interventional therapy. Patients will be treated clinically and will have regular follow-up at the outpatient clinic of the hospital at which they were treated. If patients receive continuous loop recorders for cardiac rhythm monitoring, this data will be used for the study. The other patients will undergo Holter ECG monitoring at regular intervals during follow-up (at 3, 6 and 12 months after the interventional treatment). During follow-up, the first 3 months after the interventional treatment will be a blanking period, as is common in the ablative therapy of AF (ablations points need to heal, and paroxysms of AF in this period are not associated with therapy failure).

Arms & Interventions

Arms

Active Comparator: pulmonary vein+renal artery denervation

Procedure: pulmonary vein and renal artery denervation

Active Comparator: Pulmonary vein isolation

Procedure: Pulmonary vein isolation

Interventions

Procedure: - procedure

Renal ablation+pulmonary vein isolation OR pulmonary vein isolation only

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