Combined Afib Ablation and RA Denervation for the Mainten... | NCT01952925

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

NCT01952925

Sponsor

Oregon Health and Science University

Status

Withdrawn

Last Update Posted

Feb 19, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Afib
Hypertension

Interventions

Renal Artery denervation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

unable to obtain IRB approval

Expanded Access Info

Start Date

Mar 2019Estimated

Primary Completion Date

Mar 2019Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Sep 25, 2013

First Submission Date that Met QC Criteria

Sep 27, 2013

First Posted Date

Sep 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2019

Last Update Posted Date

Feb 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Charles Henrikson, MD, Associate Professor, Knight Cardiovascular Institute, Oregon Health and Science UniversityPrincipal Investigator

Lead Sponsor

Oregon Health and Science UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Renal Artery denervation	Procedure	RA denervation performed as part of afib ablation procedure	Combined afib ablation and RA denervation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles Henrikson, MD	Oregon Health and Science University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oregon Health & Science University		Portland	Oregon	97239	United States

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D006973	Hypertension

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided