Back to resultsComparison of Redo PVI With vs. Without Renal Denervation for Recurrent AF After Initial PVI
Primary Purpose
Atrial Fibrillation, Arterial Hypertension
Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Redo PVI
PVI + RDN
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Prior PVI ablation procedure for paroxysmal AF within past 2 years
- Recurrent symptomatic paroxysmal AF despite prior PVI
- History of essential hypertension requiring at least 2 chronic antihypertensive medications
Exclusion Criteria:
- Persistent AF after prior ablation
- Congestive heart failure (NYHA III-IV functional class)
- Left ventricle ejection fraction < 35%
- Left atrial diameter >55 mm
- An estimated glomerular filtration rate (eGFR) < 45mL/min/1.73m2, using the MDRD calculation
Renal arteries unsuitable for RDN:
- Inability to access renal vasculature
- Main renal arteries < 4 mm in diameter or < 20 mm in length.
- Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
- A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment
- Multiple main renal arteries to either kidney
- Unwillingness to participate
Sites / Locations
- University of Rochester
- State Research Institute of Circulation PathologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Redo PVI
PVI + RDN
Arm Description
Therapeutic anticoagulation will be required for at least 3 weeks prior to ablation. An MRA will be performed to define cardiac and PV anatomy. Standard ablation technique will be employed. After gaining venous access, double transseptal puncture will be performed to permit left atrial access, guided by intracardiac ultrasound. A circular mapping catheter will be placed in each PV and any reconnections will be ablated by delivery of RF energy. Confirmation of re-isolation of all PVs will be performed at the conclusion of the procedure.
All patients who are randomized to Group II will undergo redo PVI exactly as described above. At the conclusion of PVI, RDN will be performed. Real-time 3-dimensional aorta-renal artery maps will be constructed with the use of the same navigation system and catheter used for PVI after femoral artery access. Both mapping and ablation will performed under the same modified sedation. RF ablations of 8 to 10 watts will be applied discretely from the first distal main renal artery bifurcation all the way back to the ostium, for 2 min, and up to 6 lesions (separated by ≥ 5 mm). Lesions will be made both longitudinally and rotationally within each renal artery. To confirm renal denervation, high-frequency stimulation (HFS) will be used before the initial and after each RF delivery within the renal artery. RDN will be considered to have been achieved when the sudden increase of blood pressure (≥ 15 mm Hg from invasive arterial monitoring) is absent.
Outcomes
Primary Outcome Measures
The absence of AF
The absence of AF at one year as assessed by prolonged ambulatory ECG monitoring post-ablation after 3 month blanking period has expired following the repeat ablation procedure.
Secondary Outcome Measures
Systolic and diastolic blood pressures
procedural duration and complications
LV mass on echocardiogram
Full Information
NCT ID
NCT01959997
First Posted
October 7, 2013
Last Updated
September 21, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT01959997
Brief Title
Comparison of Redo PVI With vs. Without Renal Denervation for Recurrent AF After Initial PVI
Official Title
Randomized Comparison of Redo Pulmonary Vein Isolation With vs. Without Renal Denervation for Recurrent Atrial Fibrillation After Initial Pulmonary Vein Isolation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
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 objective of this study is to compare the elimination of atrial fibrillation in patients with recurrent atrial fibrillation despite prior pulmonary vein isolation (PVI) when undergoing repeat PVI (control) vs repeat PVI plus renal denervation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Redo PVI
Arm Type
Active Comparator
Arm Description
Therapeutic anticoagulation will be required for at least 3 weeks prior to ablation. An MRA will be performed to define cardiac and PV anatomy. Standard ablation technique will be employed. After gaining venous access, double transseptal puncture will be performed to permit left atrial access, guided by intracardiac ultrasound. A circular mapping catheter will be placed in each PV and any reconnections will be ablated by delivery of RF energy. Confirmation of re-isolation of all PVs will be performed at the conclusion of the procedure.
Arm Title
PVI + RDN
Arm Type
Active Comparator
Arm Description
All patients who are randomized to Group II will undergo redo PVI exactly as described above.
At the conclusion of PVI, RDN will be performed. Real-time 3-dimensional aorta-renal artery maps will be constructed with the use of the same navigation system and catheter used for PVI after femoral artery access. Both mapping and ablation will performed under the same modified sedation. RF ablations of 8 to 10 watts will be applied discretely from the first distal main renal artery bifurcation all the way back to the ostium, for 2 min, and up to 6 lesions (separated by ≥ 5 mm). Lesions will be made both longitudinally and rotationally within each renal artery. To confirm renal denervation, high-frequency stimulation (HFS) will be used before the initial and after each RF delivery within the renal artery. RDN will be considered to have been achieved when the sudden increase of blood pressure (≥ 15 mm Hg from invasive arterial monitoring) is absent.
Intervention Type
Procedure
Intervention Name(s)
Redo PVI
Intervention Type
Procedure
Intervention Name(s)
PVI + RDN
Primary Outcome Measure Information:
Title
The absence of AF
Description
The absence of AF at one year as assessed by prolonged ambulatory ECG monitoring post-ablation after 3 month blanking period has expired following the repeat ablation procedure.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Systolic and diastolic blood pressures
Time Frame
1 year
Title
procedural duration and complications
Time Frame
1 year
Title
LV mass on echocardiogram
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Prior PVI ablation procedure for paroxysmal AF within past 2 years
Recurrent symptomatic paroxysmal AF despite prior PVI
History of essential hypertension requiring at least 2 chronic antihypertensive medications
Exclusion Criteria:
Persistent AF after prior ablation
Congestive heart failure (NYHA III-IV functional class)
Left ventricle ejection fraction < 35%
Left atrial diameter >55 mm
An estimated glomerular filtration rate (eGFR) < 45mL/min/1.73m2, using the MDRD calculation
Renal arteries unsuitable for RDN:
Inability to access renal vasculature
Main renal arteries < 4 mm in diameter or < 20 mm in length.
Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment
Multiple main renal arteries to either kidney
Unwillingness to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evgeny Pokushalov, MD, PhD
Phone
+79139254858
Email
e.pokushalov@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan S. Steinberg, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
Phone
+79139254858
Email
e.pokushalov@gmail.com
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Comparison of Redo PVI With vs. Without Renal Denervation for Recurrent AF After Initial PVI
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