Trial record 2 of 435 for:    Open Studies | "Atrial Fibrillation"

Treatment of Atrial Fibrillation in Patients by Pulmonary Vein Isolation, Renal Artery Denervation or Both. (ASAF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Diagram B.V.
Sponsor:
Information provided by (Responsible Party):
Diagram B.V.
ClinicalTrials.gov Identifier:
NCT02115100
First received: April 10, 2014
Last updated: April 15, 2014
Last verified: April 2014
  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 three groups.

group 1 : patients will undergo renal artery denervation/ group 2 : Patients will undergo pulmonary vein isolation/ group 3: Patients will undergo pulmonary vein isolation and renal artery denervation.


Condition Intervention
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Hypertension
Procedure: procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Atrial Fibrillation in Patients With High Sympathetic Activity by Pulmonary Vein Isolation, Renal Artery Denervation or Both; a Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Diagram B.V.:

Primary Outcome Measures:
  • Time to first detection of atrial fibrillation > 30 seconds, with the monitoring period starting 3 months after the intervention. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A-fib burden during follow-up, expressed in % of the monitoring period, in patients with continuous rhythm monitoring. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The monitoring starts after 3 months

  • Blood pressure after intervention, and change in blood pressure compared to measurement before the intervention [ Time Frame: 3/6/12 months ] [ Designated as safety issue: No ]
  • Blood pressure and heart rate response changes induced by exercise testing [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in cardiac sympathetic innervation post-intervention compared to measurement before intervention by MIBG in a subset of patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in heart rate variability measures tested by Holter monitoring compared to measurements before the intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in biomarkers post intervention representing sympathetic tone compared to before the intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in arterial stiffness measures post intervention ambulatory arterial stiffness index by ambulatory blood pressure monitoring, pulse wave velocity and augmentation index compared to measurement before the intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1
Study Start Date: April 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pulmonary vein+renal artery denervation
Procedure: pulmonary vein and renal artery denervation
Procedure: procedure
Renal ablation+pulmonair vein isolation/ Renal ablation / Pulmonair vein isolation
Other Names:
  • Renal ablation+pulmonair vein isolation
  • Renal ablation
  • Pulmonair vein isolation
Active Comparator: Pulmonary vein isolation
Procedure: Pulmonary vein isolation
Procedure: procedure
Renal ablation+pulmonair vein isolation/ Renal ablation / Pulmonair vein isolation
Other Names:
  • Renal ablation+pulmonair vein isolation
  • Renal ablation
  • Pulmonair vein isolation
Active Comparator: Renal artery denervation
Procedure: Renal artery denervation
Procedure: procedure
Renal ablation+pulmonair vein isolation/ Renal ablation / Pulmonair vein isolation
Other Names:
  • Renal ablation+pulmonair vein isolation
  • Renal ablation
  • Pulmonair vein isolation

Detailed Description:

The target group of patients are subjects ages <65 years, with paroxysmal or persistent atrial fibrillation, who have out of range hypertension (systolic >140 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: RDN (84 patients) Second arm: PVI (84 patients) Third arm: RDN+PVI (84 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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02115100

Contacts
Contact: Arif Evan, Md,Phd 031384244273 a.elvan@isala.nl
Contact: Mark de Jong 031384244273 ma.de.jong2@isala.nl

Locations
Belgium
Cliniques Universitaires Saint-Luc Not yet recruiting
Brussels, Belgium
Contact: Alexandre Persu, MC,PhD         
Principal Investigator: Alexandre persu, MD.PhD         
Netherlands
Isala Recruiting
Zwolle, Overijssel, Netherlands, 8011JW
Contact: Arif Elvan, MD,PhD    031384244273    a.elvan@isala.nl   
Contact: Mark de Jong    031384244273    ma.de.jong2@isala.nl   
Principal Investigator: Arif Elvan, MD.PhD         
Spain
Medical Advantage Not yet recruiting
Barcelona, Spain
Contact: Josef Brugada, MD.PhD    +34932275703    jbrugada@clinic.ub.es   
Contact: LLuis Mont, MD,PhD       LMONT@clinic.ub.es   
Principal Investigator: Josep Brugada, MD,PhD         
Sponsors and Collaborators
Diagram B.V.
Investigators
Principal Investigator: Arif Elvan, MD, PhD Maatschap Cardiologie Isala
  More Information

No publications provided

Responsible Party: Diagram B.V.
ClinicalTrials.gov Identifier: NCT02115100     History of Changes
Other Study ID Numbers: 9206
Study First Received: April 10, 2014
Last Updated: April 15, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Diagram B.V.:
paroxysmal atrial fibrillation
persistent atrial fibrillation
hypertension

Additional relevant MeSH terms:
Atrial Fibrillation
Hypertension
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014