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Combined Treatment of Arterial Hypertension and Atrial Fibrillation

Primary Purpose

Arterial Hypertension, Atrial Fibrillation

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Circumferential PV isolation

PV isolation+renal denervation

About this trial

This is an interventional treatment trial for Arterial Hypertension focused on measuring Arterial hypertension, Atrial Fibrillation, Percutaneous renal denervation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Valley Health System
Athens Euroclinic
State Research Institute of Circulation Pathology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

PV isolation

PV isolation+renal denervation

Arm Description

Outcomes

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

Secondary Outcome Measures

office blood pressure

safety data before and at 3, 6, 9, and 12 months after procedure

Full Information

NCT ID

NCT01897545

First Posted

July 3, 2013

Last Updated

October 8, 2013

Sponsor

Meshalkin Research Institute of Pathology of Circulation

1. Study Identification

Unique Protocol Identification Number

NCT01897545

Brief Title

Combined Treatment of Arterial Hypertension and Atrial Fibrillation

Official Title

The Role of Renal Denervation in Improving Outcomes of Catheter Ablation in Patients With Atrial Fibrillation and Arterial Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arterial Hypertension, Atrial Fibrillation

Keywords

Arterial hypertension, Atrial Fibrillation, Percutaneous renal denervation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PV isolation

Arm Type

Active Comparator

Arm Title

PV isolation+renal denervation

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Circumferential PV isolation

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

PV isolation+renal denervation

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

office blood pressure

Time Frame

1 year

Title

safety data before and at 3, 6, 9, and 12 months after procedure

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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 Previous AF ablation procedure Treatment with amiodarone Previous renal artery stenting or angioplasty Type 1 diabetes mellitus

Facility Information:

Facility Name

The Valley Health System

City

New York

State/Province

New York

Country

United States

Facility Name

Athens Euroclinic

City

Athens

ZIP/Postal Code

11528

Country

Greece

Facility Name

State Research Institute of Circulation Pathology

City

Novosibirsk

ZIP/Postal Code

630055

Country

Russian Federation

12. IPD Sharing Statement

Citations:

PubMed Identifier

24691452

Citation

Pokushalov E, Romanov A, Katritsis DG, Artyomenko S, Bayramova S, Losik D, Baranova V, Karaskov A, Steinberg JS. Renal denervation for improving outcomes of catheter ablation in patients with atrial fibrillation and hypertension: early experience. Heart Rhythm. 2014 Jul;11(7):1131-8. doi: 10.1016/j.hrthm.2014.03.055. Epub 2014 Mar 29.

Results Reference

derived

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Combined Treatment of Arterial Hypertension and Atrial Fibrillation

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