AfibNCT01952925
Combined Afib Ablation and RA Denervation for the Maintenance of Sinus Rhythm and Management of Resistant Hypertension
A study testing Renal Artery denervation in people with Afib and Hypertension, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Afib, Hypertension
- What is being tested?
- Renal Artery denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2019to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensive patients scheduled for afib ablation
- Patient taking one or more BP medication
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: 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.
- Conditions
- Afib, Hypertension
- Being tested
- Renal Artery denervation
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Artery denervationProcedure or surgery
RA denervation performed as part of afib ablation procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Renal Artery denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in systolic blood pressure when measured at routine 1 and 3 month follow up appointments
Measured: 1 to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startMar 2019 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Why it stopped: unable to obtain IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AfibStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Henrikson, MD, Oregon Health and Science University
- Investigators
- Charles Henrikson, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952925
- Sponsor's protocol ID
- RA-D-9699
- Status last verified
- Feb 2019
- First submitted
- 25 Sep 2013
- Last updated
- 19 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Atrial Fibrillation Ablation and Renal Artery Denervation for the Maintenance of Sinus Rhythm and Management of Resistant Hypertension
- ClinicalTrials.gov ID
- NCT01952925
- Acronym / sponsor ID
- RA-D-9699
- Conditions
- Afib, Hypertension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to obtain IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined afib ablation and RA denervation | Experimental | Procedure: Renal Artery denervationPatients with atrial fibrillation and resistant hypertension will be enrolled and undergo a single procedure consisting of pulmonary vein isolation and renal artery denervation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hypertensive patients scheduled for afib ablation
- Patient taking one or more BP medication
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal Artery denervationRA denervation performed as part of afib ablation procedure | Procedure or surgery | Combined afib ablation and RA denervation |
Primary outcome
change in systolic blood pressure when measured at routine 1 and 3 month follow up appointments
Time frame: 1 to 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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RecruitingPhase 2
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Henrikson, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal Artery denervation in people with Afib and Hypertension, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in systolic blood pressure when measured at routine 1 and 3 month follow up appointments (time frame: 1 to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.