Atrial FibrillationSymplicity AFNCT02064764
Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
A study testing Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter and Arctic Front Advance™ Cardiac Cryoablation System in people with Atrial Fibrillation and Hypertension, run by Medtronic Vascular at 10 sites in 2 countries.
Trial summary
The purpose of this clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a paroxysmal and persistent atrial fibrillation population with hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Hypertension
- What is being tested?
- Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter and Arctic Front Advance™ Cardiac Cryoablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Feb 2015to 19 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Drug refractory recurrent symptomatic paroxysmal or persistent atrial fibrillation
- Office-based systolic blood pressure of ≥140 mm Hg based despite treatment with 1 or more antihypertensive medications
- Age 18 years to 80 years old.
Who cannot join
- Renal artery anatomy that is ineligible for treatment including: Lacks at least one renal artery for each kidney with ≥3 mm diameter and minimum treatable length per the Spyral Instructions for Use, Renal artery stenosis (>50%) or renal artery aneurysm in either renal artery, A history of prior renal artery intervention including balloon angioplasty or stenting, Renal artery which contain calcification which does not allow at least four radio frequency ablations to be delivered , Diffuse fibromuscular dysplasia (FMD) or FMD which does not allow at least four radio frequency ablations to be delivered; FMD defined as visible beading of the artery on angiography , Unilateral kidney.
- Estimated Glomerular Filtration Rate of <30 mL/min/1.73m2.
- Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to angiography).
- Currently enrolled or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent studies is allowed when documented pre-approval is obtained from the Medtronic study manager.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
The Ohio State University
Columbus, Ohio, 43210
Doylestown Hospital
Doylestown, Pennsylvania, 18901
UPHS-Marquette
Marquette, Michigan, 49855
NYU Langone Medical Center
New York, New York, 10016
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mercy Medical Group-Cardiology
Sacramento, California, 95819
Virginia Mason Medical Center
Seattle, Washington, 98101
Swedish Medical Center Cherry Hill
Seattle, Washington, 98122-5711
About this study
The purpose of this clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a paroxysmal and persistent atrial fibrillation population with hypertension. To assess safety, the study will measure the occurrence of a composite safety endpoint and, to assess effectiveness, the study will measure freedom of chronic treatment failure through a minimum of six months of follow-up.
- Conditions
- Atrial Fibrillation, Hypertension
- Being tested
- Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter, Arctic Front Advance™ Cardiac Cryoablation System
- 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.
Symplicity Spyral™ Multi-Electrode Renal Denervation CatheterDevice
Arctic Front Advance™ Cardiac Cryoablation SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation only | Active comparator | Pulmonary vein isolation Receives: Device: Arctic Front Advance™ Cardiac Cryoablation System |
| Cryoablation and renal nerve denervation | Experimental | Pulmonary vein isolation plus renal nerve denervation Receives: Device: Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter; Device: Arctic Front Advance™ Cardiac Cryoablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects in Each Arm That Experience Safety Composite Events
Characterize the rate of safety composite events, (End stage renal disease, Death, Significant Embolic Event, Renal Artery Perforation or Dissection Requiring Intervention, Vascular Complications, Hospitalization for Hypertensive Crisis, New Renal Artery Stenosis, Cardiac Damage, Pulmonary Vein Stenosis, Atrio-Esophageal Fistula, Arrhythmia, Persistent Phrenic Nerve Palsy), within each of the two study arms and also characterize the difference in the rates between study arms. Each event in the composite has its own time frame, either one month or six months post procedure.
Measured: Up to one or six months post procedure depending on the event
Proportion of Patients With Chronic Treatment Success
Chronic treatment success is freedom from chronic treatment failure. Chronic treatment failure is defined as the occurrence of either a documented episode of AF lasting 2 or more minutes (as measured by an implantable loop recorder) or an intervention for AF.
Measured: Minimum of six months
Secondary outcomes (6)
Change in Office Systolic and Diastolic Blood Pressure at 6 Months From Baseline
Compare the difference of office systolic and diastolic blood pressure at 6 months and baseline between study arms.
Measured: 6 months
Difference in Heart Rate at 6 Months and Baseline
Compare the difference in heart rate using the 6 month follow-up measurement and baseline visit measurement. These values will then be compared between study arms.
Measured: 6 months
Procedural Measures
Elapsed fluoroscopy time and cryocatheter procedure time between study arms. Renal Denervation Procedure Time and Total Procedural Time will be reported only for the Cryoablation and Renal Denervation group.
Measured: Procedure
Proportion of Participants With Symptoms at 6 Months Between Study Arms
The endpoints for this objective are presence of the following arrhythmic symptoms as recorded at the 6-month visit through discussion with the patient at the time of the visit:
- Dizziness
- Palpitations
- Rapid heart beat
- Dyspnea
- Fatigue
- Syncope
- Other
Measured: 6 months
Rate of Chronic Treatment Success (Primary Effectiveness Endpoint) for Subjects Off of Class I and III Anti-arrhythmic Drugs Following the Blanking Period.
Compare the rate of chronic treatment success (primary effectiveness endpoint) between study arms for subjects off of Class I and III anti-arrhythmic drugs following the blanking period.
Measured: 6 months
Percent of Time in AF Burden Over All Follow-up Occurring After the Blanking Period
Compare the Percent of time in AF burden over all follow-up occurring after the blanking period between study arms.
Measured: 91 days after the cryoablation procedure date until the last Reveal LINQ device data date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startFeb 2015
- Primary completion19 Apr 2021
- Study completion19 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry Chinitz, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064764
- Sponsor's protocol ID
- Symplicity AF
- Acronym
- Symplicity AF
- Status last verified
- Jan 2024
- First submitted
- 13 Feb 2014
- Last updated
- 23 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Younis A, Steinberg JS. Renal Denervation for Patients With Atrial Fibrillation. Curr Cardiol Rep. 2021 Jul 16;23(9):126. doi: 10.1007/s11886-021-01558-4.
PubMed 34269911
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02064764
- Acronym / sponsor ID
- Symplicity AF / Symplicity AF
- Conditions
- Atrial Fibrillation, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- 19 Apr 2021 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Posted 23 Feb 2024
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 clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a paroxysmal and persistent atrial fibrillation population with hypertension. To assess safety, the study will measure the occurrence of a composite safety endpoint and, to assess effectiveness, the study will measure freedom of chronic treatment failure through a minimum of six months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoablation only | Active comparator | Device: Arctic Front Advance™ Cardiac Cryoablation SystemPulmonary vein isolation |
| Cryoablation and renal nerve denervation | Experimental | Device: Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter, Device: Arctic Front Advance™ Cardiac Cryoablation SystemPulmonary vein isolation plus renal nerve denervation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Drug refractory recurrent symptomatic paroxysmal or persistent atrial fibrillation
- Office-based systolic blood pressure of ≥140 mm Hg based despite treatment with 1 or more antihypertensive medications
- Age 18 years to 80 years old.
Key exclusion criteria (4 listed)
- Renal artery anatomy that is ineligible for treatment including: Lacks at least one renal artery for each kidney with ≥3 mm diameter and minimum treatable length per the Spyral Instructions for Use, Renal artery stenosis (>50%) or renal artery aneurysm in either renal artery, A history of prior renal artery intervention including balloon angioplasty or stenting, Renal artery which contain calcification which does not allow at least four radio frequency ablations to be delivered , Diffuse fibromuscular dysplasia (FMD) or FMD which does not allow at least four radio frequency ablations to be delivered; FMD defined as visible beading of the artery on angiography , Unilateral kidney.
- Estimated Glomerular Filtration Rate of <30 mL/min/1.73m2.
- Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to angiography).
- Currently enrolled or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent studies is allowed when documented pre-approval is obtained from the Medtronic study manager.
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 |
|---|---|---|
| Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter | Device | Cryoablation and renal nerve denervation |
| Arctic Front Advance™ Cardiac Cryoablation System | Device | Cryoablation and renal nerve denervation, Cryoablation only |
Primary outcome
Proportion of Subjects in Each Arm That Experience Safety Composite Events
Time frame: Up to one or six months post procedure depending on the event
Characterize the rate of safety composite events, (End stage renal disease, Death, Significant Embolic Event, Renal Artery Perforation or Dissection Requiring Intervention, Vascular Complications, Hospitalization for Hypertensive Crisis, New Renal Artery Stenosis, Cardiac Damage, Pulmonary Vein Stenosis, Atrio-Esophageal Fistula, Arrhythmia, Persistent Phrenic Nerve Palsy), within each of the two study arms and also characterize the difference in the rates between study arms. Each event in the composite has its own time frame, either one month or six months post procedure.
Proportion of Patients With Chronic Treatment Success
Time frame: Minimum of six months
Chronic treatment success is freedom from chronic treatment failure. Chronic treatment failure is defined as the occurrence of either a documented episode of AF lasting 2 or more minutes (as measured by an implantable loop recorder) or an intervention for AF.
6 secondary outcomes
Change in Office Systolic and Diastolic Blood Pressure at 6 Months From Baseline
Time frame: 6 months
Difference in Heart Rate at 6 Months and Baseline
Time frame: 6 months
Procedural Measures
Time frame: Procedure
Proportion of Participants With Symptoms at 6 Months Between Study Arms
Time frame: 6 months
Rate of Chronic Treatment Success (Primary Effectiveness Endpoint) for Subjects Off of Class I and III Anti-arrhythmic Drugs Following the Blanking Period.
Time frame: 6 months
Percent of Time in AF Burden Over All Follow-up Occurring After the Blanking Period
Time frame: 91 days after the cryoablation procedure date until the last Reveal LINQ device data date.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34269911Younis A, Steinberg JS. Renal Denervation for Patients With Atrial Fibrillation. Curr Cardiol Rep. 2021 Jul 16;23(9):126. doi: 10.1007/s11886-021-01558-4.
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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.
Larry Chinitz, MD principal investigator
NYU Langone Health
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter and Arctic Front Advance™ Cardiac Cryoablation System in people with Atrial Fibrillation and Hypertension, run by Medtronic Vascular at 10 sites in 2 countries.
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 4 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: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Germany. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Subjects in Each Arm That Experience Safety Composite Events (time frame: Up to one or six months post procedure depending on the event). 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?
On the ClinicalTrials.gov record for NCT02064764, which also lists 1 linked publication.
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 23 Feb 2024.