Comparison of Redo PVI With vs. Without Renal Denervation for Recurrent AF After Initial PVI

NCT01959997 | Unknown Phase 2 DMC

• 1 other identifier: RD_REDO_032
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Atrial Fibrillation; Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (3)

• Systolic and diastolic blood pressures

  1 year

• procedural duration and complications

  1 year

• LV mass on echocardiogram

  1 year

Study Arms (2)

Redo PVI

ACTIVE COMPARATOR

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.

Procedure: Redo PVI

PVI + RDN

ACTIVE COMPARATOR

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.

Procedure: PVI + RDN

Interventions

Redo PVI PROCEDURE

Redo PVI

PVI + RDN PROCEDURE

PVI + RDN

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (2)

University of Rochester

Rochester, New York, United States

ACTIVE NOT RECRUITING

State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Jonathan S. Steinberg, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evgeny Pokushalov, MD, PhD

CONTACT

+79139254858; e.pokushalov@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 10, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

US (1); RU (1)