Combined Treatment of Arterial Hypertension and Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01897545
First received: July 3, 2013
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

The purpose of this study is the comparative evaluation of systolic blood pressure (SBP) lowering, atrial fibrillation (AF) recurrence and clinical data in patients with paroxysmal/persistent AF and resistant/non-resistant hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.


Condition Intervention Phase
Arterial Hypertension
Atrial Fibrillation
Procedure: Circumferential PV isolation
Procedure: PV isolation+renal denervation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Renal Denervation in Improving Outcomes of Catheter Ablation in Patients With Atrial Fibrillation and Arterial Hypertension

Resource links provided by NLM:


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

Primary Outcome Measures:
  • recurrence of > 30 secs of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a single ablation procedure on no antiarrhythmic drug [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • office blood pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • safety data before and at 3, 6, 9, and 12 months after procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: April 2012
Study Completion Date: June 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PV isolation Procedure: Circumferential PV isolation
The left atrium (LA) and pulmonary veins (PVs) are explored through a transeptal approach. Real-time 3D LA maps are reconstructed by using a nonfluoroscopic navigation system. The ipsilateral left and right PVs are encircled in one lesion line by circumferential PV isolation. Radiofrequency energy is delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and is reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion is ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s. The endpoint of circumferential PV isolation is PV isolation. Additional ablation lines are created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs. After the end of the procedure the implantable loop recorder is implanted in the parasternal area of the chest.
Active Comparator: PV isolation+renal denervation Procedure: PV isolation+renal denervation

The procedure of AF ablation is the same like in the circumferential PV isolation.

After AF ablation procedure, the angiogram of both renal arteries is performed via femoral access. After that the treatment catheter is introduced into each renal artery and is applied discrete, radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. After the procedure the control arterial angiogram should be done.


Detailed Description:

On the basis of the eligibility criteria, patients is assigned by the enrolling physician to one of two strata. The first stratum includes patients with moderate drug-resistant hypertension, defined by the Joint National Committee VII and ESH/ESC guidelines as office BP ≥ 140/90 mm Hg and <160/100 mm Hg. The second stratum includes patients with drug-resistant hypertension, defined by office BP ≥ 160/100 mm Hg.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic drug-refractory AF (with history of failure of ≥2 class I or III antiarrhythmic drugs) in patients referred for catheter ablation of AF
  • PAF with ≥1 monthly episodes or PersAF in patients who had already undergone ≥3 electrical cardioversions. PAF was defined as episodes lasting less than 7 days with spontaneous termination. PersAF was defined as lasting more than 7 days before being terminated pharmacologically or by electrical cardioversion.
  • Office-based systolic blood pressure of ≥140/90 mm Hg, despite treatment with 3 antihypertensive drugs (including 1 diuretic)
  • A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula

Exclusion Criteria:

  • Secondary causes of hypertension
  • Severe renal artery stenosis or dual renal arteries
  • Congestive heart failure with NYHA II-IV symptoms
  • Left ventricular ejection fraction <35%
  • Transverse left atrial diameter > 60 mm on transthoracic echocardiography

    1. Previous AF ablation procedure
    2. Treatment with amiodarone
  • Previous renal artery stenting or angioplasty
  • Type 1 diabetes mellitus
  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: NCT01897545

Locations
United States, New York
The Valley Health System
New York, New York, United States
Greece
Athens Euroclinic
Athens, Greece, 11528
Russian Federation
State Research Institute of Circulation Pathology
Novosibirsk, Russian Federation, 630055
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
  More Information

No publications provided by Meshalkin Research Institute of Pathology of Circulation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01897545     History of Changes
Other Study ID Numbers: RDAFA-030
Study First Received: July 3, 2013
Last Updated: October 8, 2013
Health Authority: Russia: Ethics Committee

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Arterial hypertension
Atrial Fibrillation
Percutaneous renal denervation

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

ClinicalTrials.gov processed this record on August 19, 2014