Atrial FibrillationNCT01952743
Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation
A study testing AF ablation with Renal Denervation and AF ablation alone in people with Atrial Fibrillation and Hypertension, run by Siva Mulpuru at 1 site in United States.
Trial summary
We propose a pilot study to assess safety and benefit of renal artery ablation at the time of planned atrial fibrillation ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Hypertension
- What is being tested?
- AF ablation with Renal Denervation and AF ablation alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Oct 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paroxysmal and Persistent Atrial Fibrillation refractory eligible for AF ablation as per HRS/ECAS/EHRA consensus statement.[23] Paroxysmal AF is defined as two or more episodes of AF lasting less than 7 days in duration during the last 6 months before enrollment. Persistent AF is defined as AF lasting more than 7 days or requiring cardioversion for termination.
- Hypertension (>140/80 mm Hg) on treatment with at least 1 hypertensive medication.
- GFR >60ml/dl using Cockcroft- Gault equation
Who cannot join
- Secondary causes of hypertension
- Severe renal artery stenosis or dual renal arteries
- Congestive heart failure with NYHA class III or IV status
- EF< 35%
- LA Diameter >6 cm
- Previous AF ablation
Show all 10Show fewer
- Previous renal artery stent or angioplasty
- Severe contrast allergy
- Inability to give informed consent
- Solitary kidney
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concomitant Renal Denervation Therapy in Hypertensive Patients Undergoing Atrial Fibrillation Ablation - A Feasibility Study
We propose a pilot study to assess safety and benefit of renal artery ablation at the time of planned atrial fibrillation ablation.
Read the detailed description
Symptomatic atrial fibrillation (AF) refractory to anti-arrhythmic drugs is commonly treated with ablation therapy. Pulmonary vein isolation along with additional substrate medication is commonly performed during ablation procedures is associated with 60-80% success rate for maintenance of sinus rhythm. After AF ablation hypertension (HTN) is a strong predictor for recurrence of atrial fibrillation. Drug resistant hypertension can be effectively treated with catheter based renal denervation therapy. Our primary hypothesis is concomitant renal denervation therapy along with AF ablation is associated with improvement in success rates of AF ablation along with adequate control of blood pressure. The specific objectives of this study are to prospectively compare success rates, time to AF recurrence, AF burden and blood pressure controls in patients randomized to concomitant renal denervation arm when compared to patients with AF ablation alone.
- Conditions
- Atrial Fibrillation, Hypertension
- Being tested
- AF ablation with Renal Denervation, AF ablation alone
- Keywords
- Atrial Fibrillation, Hypertension, Renal 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.
AF ablation with Renal DenervationProcedure or surgery
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.
AF ablation aloneProcedure or surgery
Pulmonary vein isolation (PVI) is performed as per operator preference by previously described techniques.
| Study group | Role | What they receive |
|---|---|---|
| AF Ablation alone | Active comparator | Clinical AF ablation performed as deemed appropriate by operator Receives: Procedure: AF ablation alone |
| AF ablation with Renal Denervation | Experimental | Renal denervation performed using the same ablation catheter after clinical AF ablation Receives: Procedure: AF ablation with Renal Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation (AF) Time to recurrence and Burden
After 3 months of blanking period, time to recurrence of atrial arrhythmia lasting more than 30 seconds is measured during follow up. (Atrial fibrillation)AF burden is assessed on a 7 day duration event monitor. Electrocardiogram (EKG) or Event monitor strips will be evaluated by independent board certified physicians.
Measured: 1 year
Hypertension control
BP is obtained as per Joint National Committee (JNC 7) standards at 3, 6 and 12 month visits of follow up. Information regarding titration of antihypertensives or reduction in the number of medications to adequately control blood pressure is collected.
Measured: 1 year
Secondary outcomes (4)
Glomerular Filtration Rate (GFR) at 3, 6 and 12 months
Measured: 1 year
Renal artery complications by Crosssectional Imaging (Magnetic Resonance Imaging or computed tomography
Measured: 3months
Quality of life scores (MAFSI- Mayo Atrial Fibrillation Symptom Index)
Measured: 1 year
Change in left atrial volume parameters
Measured: 1 year
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 startSep 2013
- Primary completionOct 2014
- Study completionOct 2015
Why it stopped: Lack of efficacy with renal denervation in multicenter trials
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siva Mulpuru
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Siva Mulpuru, Mayo Clinic
- Investigators
- Siva K. Mulpuru, M.D., Principal investigator, Mayo Clinic, Rochester, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952743
- Sponsor's protocol ID
- 12-009062
- Status last verified
- Mar 2017
- First submitted
- 23 Sep 2013
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Renal Denervation Therapy in Hypertensive Patients Undergoing Atrial Fibrillation Ablation - A Feasibility Study
- ClinicalTrials.gov ID
- NCT01952743
- Acronym / sponsor ID
- 12-009062
- Conditions
- Atrial Fibrillation, Hypertension
- Keywords
- Atrial Fibrillation, Hypertension, Renal Denervation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy with renal denervation in multicenter trials
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Siva MulpuruUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2015 (actual)
- 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.
We propose a pilot study to assess safety and benefit of renal artery ablation at the time of planned atrial fibrillation ablation.
Detailed description
Symptomatic atrial fibrillation (AF) refractory to anti-arrhythmic drugs is commonly treated with ablation therapy. Pulmonary vein isolation along with additional substrate medication is commonly performed during ablation procedures is associated with 60-80% success rate for maintenance of sinus rhythm. After AF ablation hypertension (HTN) is a strong predictor for recurrence of atrial fibrillation. Drug resistant hypertension can be effectively treated with catheter based renal denervation therapy. Our primary hypothesis is concomitant renal denervation therapy along with AF ablation is associated with improvement in success rates of AF ablation along with adequate control of blood pressure. The specific objectives of this study are to prospectively compare success rates, time to AF recurrence, AF burden and blood pressure controls in patients randomized to concomitant renal denervation arm when compared to patients with AF ablation alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF Ablation alone | Active comparator | Procedure: AF ablation aloneClinical AF ablation performed as deemed appropriate by operator |
| AF ablation with Renal Denervation | Experimental | Procedure: AF ablation with Renal DenervationRenal denervation performed using the same ablation catheter after clinical AF ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Paroxysmal and Persistent Atrial Fibrillation refractory eligible for AF ablation as per HRS/ECAS/EHRA consensus statement.[23] Paroxysmal AF is defined as two or more episodes of AF lasting less than 7 days in duration during the last 6 months before enrollment. Persistent AF is defined as AF lasting more than 7 days or requiring cardioversion for termination.
- Hypertension (>140/80 mm Hg) on treatment with at least 1 hypertensive medication.
- GFR >60ml/dl using Cockcroft- Gault equation
Key exclusion criteria (10 listed)
- Secondary causes of hypertension
- Severe renal artery stenosis or dual renal arteries
- Congestive heart failure with NYHA class III or IV status
- EF< 35%
- LA Diameter >6 cm
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 |
|---|---|---|
| AF ablation with Renal DenervationPulmonary 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 or surgery | AF ablation with Renal Denervation |
| AF ablation alonePulmonary vein isolation (PVI) is performed as per operator preference by previously described techniques. | Procedure or surgery | AF Ablation alone |
Primary outcome
Atrial fibrillation (AF) Time to recurrence and Burden
Time frame: 1 year
After 3 months of blanking period, time to recurrence of atrial arrhythmia lasting more than 30 seconds is measured during follow up. (Atrial fibrillation)AF burden is assessed on a 7 day duration event monitor. Electrocardiogram (EKG) or Event monitor strips will be evaluated by independent board certified physicians.
Hypertension control
Time frame: 1 year
BP is obtained as per Joint National Committee (JNC 7) standards at 3, 6 and 12 month visits of follow up. Information regarding titration of antihypertensives or reduction in the number of medications to adequately control blood pressure is collected.
4 secondary outcomes
Glomerular Filtration Rate (GFR) at 3, 6 and 12 months
Time frame: 1 year
Renal artery complications by Crosssectional Imaging (Magnetic Resonance Imaging or computed tomography
Time frame: 3months
Quality of life scores (MAFSI- Mayo Atrial Fibrillation Symptom Index)
Time frame: 1 year
Change in left atrial volume parameters
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Lack of efficacy with renal denervation in multicenter trials). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Siva K. Mulpuru, M.D. principal investigator
Mayo Clinic, Rochester, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF ablation with Renal Denervation and AF ablation alone in people with Atrial Fibrillation and Hypertension, run by Siva Mulpuru 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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 22 Mar 2017. 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 stopped early (reason given: Lack of efficacy with renal denervation in multicenter trials). Results are not available in the source record.
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?
Atrial fibrillation (AF) Time to recurrence and Burden (time frame: 1 year). The study lists 2 primary outcomes in all. 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 22 Mar 2017.