NCT01952925

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
5.4 years until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

Same day

First QC Date

September 25, 2013

Last Update Submit

February 17, 2019

Conditions

AfibHypertension

Outcome Measures

Primary Outcomes (1)

  • change in systolic blood pressure when measured at routine 1 and 3 month follow up appointments

    1 to 3 months

Study Arms (1)

Combined afib ablation and RA denervation

EXPERIMENTAL

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

Interventions

Renal Artery denervationPROCEDURE

RA denervation performed as part of afib ablation procedure

Combined afib ablation and RA denervation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Atrial FibrillationHypertension

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Study Officials

  • Charles Henrikson, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Knight Cardiovascular Institute

Study Record Dates

First Submitted

September 25, 2013

First Posted

September 30, 2013

Study Start

March 1, 2019

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

February 19, 2019

Record last verified: 2019-02

Locations

US(1)