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

NCT02115100 | Completed DMC

• 1 other identifier: 9206
• Study Type: interventional
• Target: 145
• Locations: 2 countries
• Sites: 8

Brief Summary

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.

Conditions

Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Out of Range Hypertension; Signs of Sympathetic Overdrive

Keywords

Paroxysmal atrial fibrillation; Persistent atrial fibrillation; Out of range hypertension; Signs of sympathetic overdrive

Outcome Measures

Primary Outcomes (1)

• Time to first detection of atrial fibrillation > 30 seconds, with the monitoring period starting 3 months after the intervention.

  3 months

Secondary Outcomes (7)

• A-fib burden during follow-up, expressed in % of the monitoring period, in patients with continuous rhythm monitoring.

  12 months

• Blood pressure after intervention, and change in blood pressure compared to measurement before the intervention

  3/6/12 months

• Blood pressure and heart rate response changes induced by exercise testing

  12 months

• Changes in cardiac sympathetic innervation post-intervention compared to measurement before intervention by MIBG in a subset of patients

  12 months

• Changes in heart rate variability measures tested by Holter monitoring compared to measurements before the intervention

  12 months

Study Arms (2)

pulmonary vein+renal artery denervation

ACTIVE COMPARATOR

Procedure: pulmonary vein and renal artery denervation

Procedure: procedure

Pulmonary vein isolation

ACTIVE COMPARATOR

Procedure: Pulmonary vein isolation

Procedure: procedure

Interventions

procedure PROCEDURE

Renal ablation+pulmonary vein isolation OR pulmonary vein isolation only

Also known as: Renal ablation+pulmonary vein isolation OR pulmonary vein isolation only

Pulmonary vein isolation; pulmonary vein+renal artery denervation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Diagram B.V.: lead

Study Sites (8)

Isala hospital

Zwolle, Overijssel, 8313AB, Netherlands

Location

MUMC

Maastricht, Netherlands

Location

Radboudumc

Nijmegen, Netherlands

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Hospital Fundación Jimenez Díaz

Madrid, Spain

Location

Hospital Puerta de Hierro

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Location

Related Publications (1)

• Younis A, Steinberg JS. Renal Denervation for Patients With Atrial Fibrillation. Curr Cardiol Rep. 2021 Jul 16;23(9):126. doi: 10.1007/s11886-021-01558-4.

  PMID: 34269911 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Methods

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Arif Elvan, MD, PhD

  Maatschap Cardiologie Isala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 15, 2014
• Study Start: March 18, 2014
• Primary Completion: January 19, 2022
• Study Completion: January 19, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Locations

NL (3); ES (5)