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Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation

NCT01952743 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-03-22

No results posted yet for this study

Summary

We propose a pilot study to assess safety and benefit of renal artery ablation at the time of planned atrial fibrillation ablation.

Conditions

Interventions

PROCEDURE

AF ablation with Renal Denervation

Pulmonary vein isolation (PVI) is performed as per operator preference by previously described techniques. Both mapping and ablation are performed under general anesthesia. The use of standard electrophysiology ablation catheter to perform renal artery ablation in hypertensive patients has been previously described. UP to 2 minutes of RF energy (10W with irrigation flow of 17 ml/min) are delivered at each location and up to 6 lesions for each artery on the longitudinal and rotational axis. Renal denervation is performed on both vascular pedicles after clinical AF ablation in patients assigned to the intervention arm.

PROCEDURE

AF ablation alone

Pulmonary vein isolation (PVI) is performed as per operator preference by previously described techniques.

Sponsors & Collaborators

  • Siva Mulpuru

    lead OTHER

Principal Investigators

  • Siva K. Mulpuru, M.D. · Mayo Clinic, Rochester, MN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01952743 on ClinicalTrials.gov