Paroxysmal Atrial FibrillationASAFNCT02115100
Treatment of Atrial Fibrillation in Patients by Pulmonary Vein Isolation in Combination With Renal Denervation or Pulmonary Vein Isolation Only
A study testing procedure in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Diagram B.V. at 8 sites in 2 countries.
Trial summary
Prospective, randomized, controlled, multicenter, international clinical trial. The study population consist of patients with paroxysmal or persistent atrial fibrillation with out range hypertension or signs of sympathetic overdrive. Patient will be randomized into one of the following two groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Out of Range Hypertension
- What is being tested?
- procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 18 Mar 2014to 19 Jan 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is willing and able to comply with the protocol and has provided written informed consent.
- The patient falls within the target group resistant hypertension or sympathetic overdrive
- Patient is an acceptable candidate for renal denervation treatment
- Patient is < 65 year of age
Who cannot join
- Documented left atrial diameter on trans thoracic echocardiography (PLAX > 4.5 cm).
- Contraindication to chronic anticoagulation therapy or heparin.
- Previous left heart ablation procedure for AF (atrial fibrillation).
- Acute coronary syndrome, cardiac surgery, PCI (percutaneous coronary intervention)or stroke within 3 months prior to enrollment.
- Untreated hypothyroidism or hyperthyroidism.
- More than grade 1/3 valvular regurgitation and/or significant valve stenosis (modest or severe).
Show all 16Show fewer
- LVEF (Left ventricular function) <45% and/or grade 3/4 diastolic dysfunction.
- Enrollment in another investigational drug or device study.
- Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age.
- Mental or physical inability to participate in the study.
- Planned cardiovascular intervention.
- Life expectancy ≤ 12 months.
- Renal artery stenosis >50% of the arterial lumen, or renal artery lumen
- ≤3 mm.
- Dual or triple ipsilateral renal artery ostia.
- Obvious secondary cause of hypertension.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Spain5 sites
Hospital Clinic de Barcelona
Barcelona
Hospital Fundación Jimenez Díaz
Madrid
Hospital Puerta de Hierro
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Virgen de la Victoria
Málaga
Netherlands3 sites
MUMC
Maastricht
Radboudumc
Nijmegen
Isala hospital
Zwolle, Overijssel, 8313AB
About this study
Official title: Treatment of Atrial Fibrillation in Patients With High Sympathetic Activity by Pulmonary Vein Isolation in Combination With Renal Denervation or Pulmonary Vein Isolation Only; an International Randomized, Controlled Trial
Prospective, randomized, controlled, multicenter, international clinical trial. The study population consist of patients with paroxysmal or persistent atrial fibrillation with out range hypertension or signs of sympathetic overdrive. Patient will be randomized into one of the following two groups.
group 1 : patients will undergo pulmonary vein isolation, group 2: Patients will undergo pulmonary vein isolation and renal artery denervation.
Read the detailed description
The target group of patients are subjects ages <65 years, with paroxysmal or persistent atrial fibrillation, who have out of range hypertension (systolic >140 mmHg or >130/80 mmHg in diabetics and patients with chronic renal disease) or signs of sympathetic overdrive. Patients should use at least 2 anti-hypertensive's or should be intolerant for antihypertensive medication.
Atrial fibrillation terminology: If atrial fibrillation recurs more than once but terminates spontaneously within seven days, the term paroxysmal AF is used. This is also used when the episode is less than 48 hours in duration and is terminated with electrical or pharmacological cardioversion. Persistent AF is defined as recurrent AF that is sustained for more than seven days. A patient that is electrically or pharmacologically cardioverted after more than two days is also diagnosed with persistent AF.
After the exclusion of apparent secondary causes of hypertension, patients will be randomized to one of the following interventional treatments:
First arm: PVI (69 patients) Second arm: PVI + RDN (69 patients)
The patient will be treated under conscious sedation or general anesthesia. The control group will consist of patients who undergo PVI alone. The study will be a randomized, controlled trial. The follow up period will be up to one year after the interventional therapy. Patients will be treated clinically and will have regular follow-up at the outpatient clinic of the hospital at which they were treated. If patients receive continuous loop recorders for cardiac rhythm monitoring, this data will be used for the study. The other patients will undergo Holter ECG monitoring at regular intervals during follow-up (at 3, 6 and 12 months after the interventional treatment). During follow-up, the first 3 months after the interventional treatment will be a blanking period, as is common in the ablative therapy of AF (ablations points need to heal, and paroxysms of AF in this period are not associated with therapy failure).
- Conditions
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Out of Range Hypertension, Signs of Sympathetic Overdrive
- Being tested
- procedure
- Keywords
- Paroxysmal atrial fibrillation, Persistent atrial fibrillation, Out of range hypertension, Signs of sympathetic overdrive
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procedureProcedure or surgery
Also called Renal ablation+pulmonary vein isolation OR pulmonary vein isolation only
Renal ablation+pulmonary vein isolation OR pulmonary vein isolation only
| Study group | Role | What they receive |
|---|---|---|
| pulmonary vein+renal artery denervation | Active comparator | Procedure: pulmonary vein and renal artery denervation Receives: Procedure: procedure |
| Pulmonary vein isolation | Active comparator | Procedure: Pulmonary vein isolation Receives: Procedure: procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first detection of atrial fibrillation > 30 seconds, with the monitoring period starting 3 months after the intervention.
Measured: 3 months
Secondary outcomes (7)
A-fib burden during follow-up, expressed in % of the monitoring period, in patients with continuous rhythm monitoring.
The monitoring starts after 3 months
Measured: 12 months
Blood pressure after intervention, and change in blood pressure compared to measurement before the intervention
Measured: 3/6/12 months
Blood pressure and heart rate response changes induced by exercise testing
Measured: 12 months
Changes in cardiac sympathetic innervation post-intervention compared to measurement before intervention by MIBG in a subset of patients
Measured: 12 months
Changes in heart rate variability measures tested by Holter monitoring compared to measurements before the intervention
Measured: 12 months
Changes in biomarkers post intervention representing sympathetic tone compared to before the intervention
Measured: 12 months
Changes in arterial stiffness measures post intervention ambulatory arterial stiffness index by ambulatory blood pressure monitoring, pulse wave velocity and augmentation index compared to measurement before the intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study start18 Mar 2014
- Primary completion19 Jan 2022
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diagram B.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arif Elvan, MD, PhD, Principal investigator, Maatschap Cardiologie Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115100
- Sponsor's protocol ID
- 9206
- Acronym
- ASAF
- Status last verified
- Jul 2022
- First submitted
- 10 Apr 2014
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- 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 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Atrial Fibrillation in Patients With High Sympathetic Activity by Pulmonary Vein Isolation in Combination With Renal Denervation or Pulmonary Vein Isolation Only; an International Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02115100
- Acronym / sponsor ID
- ASAF / 9206
- Conditions
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Out of Range Hypertension, Signs of Sympathetic Overdrive
- Keywords
- Paroxysmal atrial fibrillation, Persistent atrial fibrillation, Out of range hypertension, Signs of sympathetic overdrive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Diagram B.V.University, hospital or other
- Study start
- 18 Mar 2014 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 15 Apr 2014 (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.
Prospective, randomized, controlled, multicenter, international clinical trial. The study population consist of patients with paroxysmal or persistent atrial fibrillation with out range hypertension or signs of sympathetic overdrive. Patient will be randomized into one of the following two groups.
group 1 : patients will undergo pulmonary vein isolation, group 2: Patients will undergo pulmonary vein isolation and renal artery denervation.
Detailed description
The target group of patients are subjects ages <65 years, with paroxysmal or persistent atrial fibrillation, who have out of range hypertension (systolic >140 mmHg or >130/80 mmHg in diabetics and patients with chronic renal disease) or signs of sympathetic overdrive. Patients should use at least 2 anti-hypertensive's or should be intolerant for antihypertensive medication.
Atrial fibrillation terminology: If atrial fibrillation recurs more than once but terminates spontaneously within seven days, the term paroxysmal AF is used. This is also used when the episode is less than 48 hours in duration and is terminated with electrical or pharmacological cardioversion. Persistent AF is defined as recurrent AF that is sustained for more than seven days. A patient that is electrically or pharmacologically cardioverted after more than two days is also diagnosed with persistent AF.
After the exclusion of apparent secondary causes of hypertension, patients will be randomized to one of the following interventional treatments:
First arm: PVI (69 patients) Second arm: PVI + RDN (69 patients)
The patient will be treated under conscious sedation or general anesthesia. The control group will consist of patients who undergo PVI alone. The study will be a randomized, controlled trial. The follow up period will be up to one year after the interventional therapy. Patients will be treated clinically and will have regular follow-up at the outpatient clinic of the hospital at which they were treated. If patients receive continuous loop recorders for cardiac rhythm monitoring, this data will be used for the study. The other patients will undergo Holter ECG monitoring at regular intervals during follow-up (at 3, 6 and 12 months after the interventional treatment). During follow-up, the first 3 months after the interventional treatment will be a blanking period, as is common in the ablative therapy of AF (ablations points need to heal, and paroxysms of AF in this period are not associated with therapy failure).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulmonary vein+renal artery denervation | Active comparator | Procedure: procedureProcedure: pulmonary vein and renal artery denervation |
| Pulmonary vein isolation | Active comparator | Procedure: procedureProcedure: Pulmonary vein isolation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient is willing and able to comply with the protocol and has provided written informed consent.
- The patient falls within the target group resistant hypertension or sympathetic overdrive
- Patient is an acceptable candidate for renal denervation treatment
- Patient is < 65 year of age
Key exclusion criteria (16 listed)
- Documented left atrial diameter on trans thoracic echocardiography (PLAX > 4.5 cm).
- Contraindication to chronic anticoagulation therapy or heparin.
- Previous left heart ablation procedure for AF (atrial fibrillation).
- Acute coronary syndrome, cardiac surgery, PCI (percutaneous coronary intervention)or stroke within 3 months prior to enrollment.
- Untreated hypothyroidism or hyperthyroidism.
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 |
|---|---|---|
| procedureAlso: Renal ablation+pulmonary vein isolation OR pulmonary vein isolation onlyRenal ablation+pulmonary vein isolation OR pulmonary vein isolation only | Procedure or surgery | Pulmonary vein isolation, pulmonary vein+renal artery denervation |
Primary outcome
Time to first detection of atrial fibrillation > 30 seconds, with the monitoring period starting 3 months after the intervention.
Time frame: 3 months
7 secondary outcomes
A-fib burden during follow-up, expressed in % of the monitoring period, in patients with continuous rhythm monitoring.
Time frame: 12 months
Blood pressure after intervention, and change in blood pressure compared to measurement before the intervention
Time frame: 3/6/12 months
Blood pressure and heart rate response changes induced by exercise testing
Time frame: 12 months
Changes in cardiac sympathetic innervation post-intervention compared to measurement before intervention by MIBG in a subset of patients
Time frame: 12 months
Changes in heart rate variability measures tested by Holter monitoring compared to measurements before the intervention
Time frame: 12 months
Changes in biomarkers post intervention representing sympathetic tone compared to before the intervention
Time frame: 12 months
Changes in arterial stiffness measures post intervention ambulatory arterial stiffness index by ambulatory blood pressure monitoring, pulse wave velocity and augmentation index compared to measurement before the intervention
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- 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.
Related trials for Paroxysmal 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
RecruitingObservational study
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Atrial Fibrillation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruitingObservational study
Catheter Ablation Using a Novel Navigation and Imaging System
Paroxysmal Atrial Fibrillation
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.
Arif Elvan, MD, PhD principal investigator
Maatschap Cardiologie Isala
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing procedure in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Diagram B.V. at 8 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 4 inclusion and 16 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 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to first detection of atrial fibrillation > 30 seconds, with the monitoring period starting 3 months after the intervention. (time frame: 3 months). 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 NCT02115100, 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 12 Jul 2022.