Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation (ERADICATE--AF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Meshalkin Research Institute of Pathology of Circulation
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01873352
First received: June 5, 2013
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

The objective of this trial is to determine the role of renal sympathetic denervation in the prevention of atrial fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.


Condition Intervention Phase
Atrial Fibrillation
Hypertension
Procedure: catheter ablation
Procedure: renal sympathetic denervation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluate Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation (ERADICATE--AF) Trial

Resource links provided by NLM:


Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:
  • AAD-free freedom from AF recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Freedom from AF recurrence (not-including the pre-defined 3 month blanking period) despite taking AADs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Blood pressure control between the two groups as compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Blood pressure control between the two groups as compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Differences in plasma norepinephrine and BNP measurements [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Differences in plasma norepinephrine and BNP measurements [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Differences in measures of LV hypertrophy/compliance (LV wall thickness, mitral inflow parameters) and LA size [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Procedure adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Major adverse cardiac events (defined as a composite of: death, stroke, CHF hospitalization, clinically diagnosed thromboembolic events other than stroke and hemorrhage requiring transfusion) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Serious adverse events throughout follow-up [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Total number of anti-hypertensive medications at study end, compared between the two treatment arms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CA+RD
Catheter ablation of atrial fibrillation plus renal sympathetic denervation
Procedure: catheter ablation
Patient anesthesia will be administered according to standard EP lab protocol. Arterial and venous access will be achieved through cannulation of the right and/or left femoral arteries and veins as per the usual practice of the EP lab. Full systemic anticoagulation will be instituted as per standard hospital procedures to a target ACT of approximately 300 seconds or greater. Intravascular ultrasound may be used to assist in the positioning of study catheters during the procedure. The AF ablation procedure will be performed using a cryoballoon ablation catheter. Complete pulmonary vein isolation will be the goal of the ablation procedure and PV isolation must be confirmed by a multielectrode mapping catheter within each PV. Pulmonary vein isolation is the only intervention. A cavo-tricuspid isthmus line may be placed in patients with either a history of ECG-determined typical flutter or induced typical flutter during the procedure.
Procedure: renal sympathetic denervation
Right or left femoral artery access. Real-time 3D aorta-renal artery maps constructed with the use of a navigation system and ablation catheter. Mapping and ablation performed after PVI and under identical sedation protocol used for AF ablation. RF delivery of 6 watts to be applied discretely from the first distal main renal artery bifurcation all the way back to the ostium; RF duration of each delivery 1.5 mins; lesions delivered at multiple sites based on multipolar catheter position within renal artery. Use of specifically designed RF delivery system for renal artery denervation is mandatory (RDN). To confirm renal denervation, high-frequency stimulation (HFS) will be applied before the initial and after each RF delivery within the renal artery. Rectangular electrical stimuli will be delivered at the ostium of the targeted renal artery at a frequency of 20 Hz, with an amplitude 15 V and pulse duration of 10 ms for 10 secs.
Active Comparator: CA (control)
Catheter ablation of atrial fibrillation (control group)
Procedure: catheter ablation
Patient anesthesia will be administered according to standard EP lab protocol. Arterial and venous access will be achieved through cannulation of the right and/or left femoral arteries and veins as per the usual practice of the EP lab. Full systemic anticoagulation will be instituted as per standard hospital procedures to a target ACT of approximately 300 seconds or greater. Intravascular ultrasound may be used to assist in the positioning of study catheters during the procedure. The AF ablation procedure will be performed using a cryoballoon ablation catheter. Complete pulmonary vein isolation will be the goal of the ablation procedure and PV isolation must be confirmed by a multielectrode mapping catheter within each PV. Pulmonary vein isolation is the only intervention. A cavo-tricuspid isthmus line may be placed in patients with either a history of ECG-determined typical flutter or induced typical flutter during the procedure.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years of age
  • History of PAF and plans for a guideline-supported catheter ablation procedure. Paroxysmal AF is defined as AF with duration of 30 secs to 7 days.
  • History of significant hypertension (defined as SBP ≥130 mm Hg and/or DBP ≥80 mmHg) and receiving treatment with at least one anti-hypertensive medication
  • Renal vasculature accessible as determined by pre-procedural renal MRA
  • Willingness to comply with all post-procedural follow-up requirements and to sign informed consent

Exclusion Criteria:

  • Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
  • Prior left atrial ablation for an atrial arrhythmia
  • NYHA class IV congestive heart failure
  • Pers or longstanding Pers AF (duration > 7 days)
  • Renal artery anatomy that is ineligible for treatment
  • An estimated glomerular filtration rate (eGFR) < 45mL/min/1.73m2, using the MDRD calculation
  • Life expectancy <1 year for any medical condition
  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: NCT01873352

Locations
United States, New York
The Valley Health System and Columbia University College of Physicians & Surgeons Recruiting
New York, New York, United States
Contact: Jonathan Steinberg, MD       jss7@columbia.edu   
Principal Investigator: Jonathan Steinberg, MD         
Sub-Investigator: Suneet Mittal, MD         
Russian Federation
State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Evgeny Pokushalov, MD, PhD, FESC    +79139254858    e.pokushalov@gmail.com   
Principal Investigator: Evgeny Pokushalov, MD, PhD         
Sub-Investigator: Alexander Romanov, MD, PhD         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Evgeny Pokushalov, MD, PhD State Research Institute of Circulation Pathology
Principal Investigator: Jonathan S. Steinberg, MD The Valley Health System and Columbia University College of Physicians & Surgeons
  More Information

Additional Information:
No publications provided

Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01873352     History of Changes
Other Study ID Numbers: RADCA01
Study First Received: June 5, 2013
Last Updated: December 6, 2013
Health Authority: Russia: Ethics Committee

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

ClinicalTrials.gov processed this record on October 01, 2014