Combined Treatment of Resistant 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:
NCT01117025
First received: April 30, 2010
Last updated: July 8, 2013
Last verified: July 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 hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.


Condition Intervention Phase
Hypertension, Resistant to Conventional Therapy
Atrial Fibrillation
Procedure: Circumferential PV isolation
Procedure: Circumferential PVI+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 Refractory Symptomatic Atrial Fibrillation and Resistant Hypertension

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Freedom of AF or other atrial arrhythmias [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Systolic blood pressure lowering [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: April 2010
Study Completion Date: April 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Circumferential PVI 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: Circumferential PVI+renal denervation Procedure: Circumferential PVI+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.


  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 ≥160 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:

  • Previous atrial fibrillation ablation
  • Type 1 of diabetes mellitus
  • Structural heart disease
  • Secondary cause of atrial hypertension
  • Severe renal artery stenosis or renal arteries abnormalities
  • Previous operations on renal arteries
  • Pregnancy
  • Previous heart, kidney, liver, or lung transplantation
  • Unwillingness of participant
  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: NCT01117025

Locations
United States, New York
The Valley Health System
New York, New York, United States
Russian Federation
State Research Institute of Circulation Pathology
Novosibirsk, Russian Federation, 630055
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Evgeny A Pokushalov, MD, PhD State Research Institute of Circulation Pathology
  More Information

Publications:
Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01117025     History of Changes
Other Study ID Numbers: RDAFA-029, RU MC 001
Study First Received: April 30, 2010
Last Updated: July 8, 2013
Health Authority: Russia: Ethics Committee

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Resistant 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 July 23, 2014