Combined Afib Ablation and RA Denervation for the Maintenance of Sinus Rhythm and Management of Resistant Hypertension

February 17, 2019 updated by: Charles Henrikson, MD, Oregon Health and Science University

Combined Atrial Fibrillation Ablation and Renal Artery Denervation for the Maintenance of Sinus Rhythm and Management of Resistant Hypertension

The purpose of this study is to perform renal artery denervation at the same time as atrial fibrillation ablation. RA denervation may reduce blood pressure, increase the chances of a successful atrial fibrillation ablation, and decrease the number of medications required to control blood pressure.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hypertensive patients scheduled for afib ablation
  • Patient taking one or more BP medication

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined afib ablation and RA denervation
Patients with atrial fibrillation and resistant hypertension will be enrolled and undergo a single procedure consisting of pulmonary vein isolation and renal artery denervation.
Procedure: Renal Artery denervation
RA denervation performed as part of afib ablation procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in systolic blood pressure when measured at routine 1 and 3 month follow up appointments
Time Frame: 1 to 3 months
1 to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Charles Henrikson, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

September 27, 2013

First Posted (Estimate)

September 30, 2013

Study Record Updates

Last Update Posted (Actual)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 17, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA-D-9699

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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