Persistent Atrial FibrillationRDN+AFNCT01907828

A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence

A study testing Renal Artery Ablation and Cardiac Ablation in people with Persistent Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this post market clinical investigation is to complete preliminary evaluation on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System and cardiac ablation will result in improved outcomes as compared to ablation alone in patients with uncontrolled hypertension being… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Hypertension
What is being tested?: Renal Artery Ablation and Cardiac Ablation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 2 sitesGermany
Study dates: 15 Apr 2014to 15 Oct 2018
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is ≥ 18 years of age at time of consent
Subject must be able and willing to provide written informed consent
Subject must be able and willing to comply with the required follow-up schedule
Subject is a candidate for catheter ablation for the treatment of paroxysmal or persistent atrial fibrillation as per the hospital standard of care
Subject has office Systolic Blood Pressure ≥ 140 mmHg at baseline visit
Subject has a daytime mean Systolic Ambulatory Blood Pressure > 135 mmHg within 90 days prior to procedure
Subject has established hypertension (diagnosed ≥12 month prior to baseline) and is taking >3 anti-hypertensive medications, including 1 diuretic
Subject has been on a stable unchanged anti-hypertensive medication regimen for a minimum of 4 weeks prior to the ablation procedure

Who cannot join

Subject has long standing atrial fibrillation
Subject has had a previous ablation for atrial fibrillation
Subject has had a previous renal denervation procedure
Subject has had a CABG procedure within the last 180 days (six months)
Subject has a left atrial thrombus
Subject has a contraindication to anticoagulation (i.e. heparin or warfarin)

Show all 21Show fewer

Subject has unstable angina
Subject has had a myocardial infarction within the previous two months
Subject has a left ventricular ejection fraction (LVEF) <40% as determined by pre-procedure TTE
Subject has significant renovascular abnormalities such as renal artery stenosis > 30%
Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
Subject has hemodynamically significant valvular heart disease as determined by study investigator
Subject has a life expectancy less than 12 months, as determined by the study investigator
Subject is participating in another clinical study which has the potential to impact his/her hypertension or atrial fibrillation management (pharmaceutical/device/homeopathic)
Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
Subject has active systemic infection
Subject has renal arteries < 4 mm in diameter
Subject has an estimated GFR <45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
Subject had a renal transplant or is awaiting a renal transplant
Subject has blood clotting or bleeding abnormalities
Subject has secondary arterial hypertension

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Herzzentrum Dresden GmbH Universitätsklinik
Dresden, 01307
Herzzentrum Leipzig GmbH
Leipzig, 04289

Other trials in Germany

About this study

Read the detailed description

This is a post market, prospective, multicenter, 2:1 randomized study of the EnligHTN™ Renal Denervation System in conjunction with atrial fibrillation ablation. Up to one hundred subjects with paroxysmal or persistent atrial fibrillation and uncontrolled hypertension will be enrolled in the study. All subjects will undergo cardiac ablation for the treatment of atrial fibrillation. Per the 2:1 randomization, a minimum of 50 or 2/3 of the total patient cohort will also undergo renal artery ablation. Subjects will be followed up to years (2) years post procedure.

Conditions: Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Hypertension
Being tested: Renal Artery Ablation, Cardiac Ablation
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 AblationDevice
Renal artery denervation using the EnligHTN™ Renal Denervation System
Cardiac AblationDevice
Safire BLU™ Duo or Therapy Cool Path Duo Irrigated Ablation Catheter or Therapy Cool Flex Irrigated Ablation Catheter EnSite Velocity System Agilis NxT Guiding Introducer

Study groups in NCT01907828
Study group	Role	What they receive
Cardiac ablation + renal artery ablation	Experimental	Renal artery ablation with the EnligHTN™ Renal Denervation System Receives: Device: Renal Artery Ablation; Device: Cardiac Ablation
Cardiac ablation	Active comparator	Cardiac ablation Receives: Device: Cardiac Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Freedom From Atrial Fibrillation at 12 Month
The freedom from atrial fibrillation was assessed based on electrocardiographic data during nine months following the blanking period including the one week recording coinciding with the 12 month follow-up visit (9 months following the 3 month blanking period).
Measured: 12 months

Secondary outcomes (11)

Major Adverse Cardiac Events (MACE)
Major adverse cardiac events (MACE) were summarized as a percentage based on number of subjects at baseline for each group (RDN+AF group = 39, AF group = 22).
Measured: 7 days, 6 months, 12 months, and 24 months post procedure
Percentage of Participants Who Experience Peri-procedural Events
Peri-procedural events within 30 days post procedure were summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22)
Measured: 30 days post procedure
Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation
Renovascular safety (new renal artery stenosis or aneurysm) was summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22).
Measured: 6 months and 12 months post procedure
Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months
Measured: Baseline and 6 months
Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months
Measured: Baseline and 12 months
Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure.
Recurrence of AF was summarized as a percentage based on the number of subjects who underwent the procedure (RDN+AF group= 39, AF group=20)
Measured: 3 months, 6 months, 12 months, 24 months
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg
Measured: 6 months post procedure
Change in Ambulatory Blood Pressure at 12 Months
Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 22, AF group=14)
Measured: Baseline and 12 months post procedure
Change in Ambulatory Blood Pressure at 24 Months
Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 17, AF group=12)
Measured: Baseline and 24 months post procedure
Change in Office Blood Pressure at 12 Months
Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 33, AF group=15)
Measured: Baseline and 12 months post procedure
Change in Office Blood Pressure at 24 Months
Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 29, AF group=16).
Measured: Baseline and 24 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 201415 Oct 2018

First posted25 Jul 2013 (estimated)
Study start15 Apr 2014
Primary completion15 Oct 2018
Study completion15 Oct 2018

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 Persistent Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01907828
Sponsor's protocol ID: SJM-CIP-0009
Acronym: RDN+AF
Status last verified: May 2020
First submitted: 17 Jul 2013
Last updated: 22 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Kirstein B, Tomala J, Mayer J, Ulbrich S, Wagner M, Pu L, Piorkowski J, Hankel A, Huo Y, Gaspar T, Richter U, Hindricks G, Piorkowski C. Effect of concomitant Renal DeNervation and cardiac ablation on Atrial Fibrillation recurrence - RDN+AF study. J Cardiovasc Electrophysiol. 2023 Jan;34(1):44-53. doi: 10.1111/jce.15714. Epub 2022 Dec 1.
PubMed 36259713

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Not yet recruiting
Dual-Energy Lattice-Tip Assisted Marshall-Plan Strategy in Redo Persistent Atrial Fibrillation Ablation
Atrial Fibrillation (AF)
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Recruiting
PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
Persistent Atrial Fibrillation

All Persistent Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence
ClinicalTrials.gov ID: NCT01907828
Acronym / sponsor ID: RDN+AF / SJM-CIP-0009
Conditions: Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: 15 Apr 2014 (actual)
Primary completion: 15 Oct 2018 (actual)
Study completion: 15 Oct 2018 (actual)
First posted: 25 Jul 2013 (estimated)
Results: Posted 22 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cardiac ablation + renal artery ablation	Experimental	Device: Renal Artery Ablation, Device: Cardiac AblationRenal artery ablation with the EnligHTN™ Renal Denervation System
Cardiac ablation	Active comparator	Device: Cardiac AblationCardiac ablation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subject is ≥ 18 years of age at time of consent
Subject must be able and willing to provide written informed consent
Subject must be able and willing to comply with the required follow-up schedule
Subject is a candidate for catheter ablation for the treatment of paroxysmal or persistent atrial fibrillation as per the hospital standard of care
Subject has office Systolic Blood Pressure ≥ 140 mmHg at baseline visit

Key exclusion criteria (21 listed)

Subject has long standing atrial fibrillation
Subject has had a previous ablation for atrial fibrillation
Subject has had a previous renal denervation procedure
Subject has had a CABG procedure within the last 180 days (six months)
Subject has a left atrial thrombus

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 AblationRenal artery denervation using the EnligHTN™ Renal Denervation System	Device	Cardiac ablation + renal artery ablation
Cardiac AblationSafire BLU™ Duo or Therapy Cool Path Duo Irrigated Ablation Catheter or Therapy Cool Flex Irrigated Ablation Catheter EnSite Velocity System Agilis NxT Guiding Introducer	Device	Cardiac ablation, Cardiac ablation + renal artery ablation

Primary outcome

Number of Participants With Freedom From Atrial Fibrillation at 12 Month
Time frame: 12 months
The freedom from atrial fibrillation was assessed based on electrocardiographic data during nine months following the blanking period including the one week recording coinciding with the 12 month follow-up visit (9 months following the 3 month blanking period).

11 secondary outcomes

Major Adverse Cardiac Events (MACE)
Time frame: 7 days, 6 months, 12 months, and 24 months post procedure
Percentage of Participants Who Experience Peri-procedural Events
Time frame: 30 days post procedure
Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation
Time frame: 6 months and 12 months post procedure
Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months
Time frame: Baseline and 6 months
Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months
Time frame: Baseline and 12 months
Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure.
Time frame: 3 months, 6 months, 12 months, 24 months
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg
Time frame: 6 months post procedure
Change in Ambulatory Blood Pressure at 12 Months
Time frame: Baseline and 12 months post procedure
Change in Ambulatory Blood Pressure at 24 Months
Time frame: Baseline and 24 months post procedure
Change in Office Blood Pressure at 12 Months
Time frame: Baseline and 12 months post procedure
Change in Office Blood Pressure at 24 Months
Time frame: Baseline and 24 months post procedure

Results and safety

Results posted to the registry on 22 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Renal Artery Ablation + Cardiac Ablation (RDN+AF)	39	32
Cardiac Ablation (AF)	22	16

Primary outcome: Number of Participants With Freedom From Atrial Fibrillation at 12 Month

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Renal Artery Ablation + Cardiac Ablation (RDN+AF) n = 28	Cardiac Ablation (AF) n = 12
Value	16	4

Renal Artery Ablation + Cardiac Ablation (RDN+AF) vs Cardiac Ablation (AF): p = 0.22, Log Rank

Population analysed: Data not collected from all participants: data were available for only 28 participants in the RDN+AF group, and 12 participants in the AF group

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Renal Artery Ablation + Cardiac Ablation (RDN+AF)	4 of 39 (10.3%)	4 of 39 (10.3%)	0 of 39
Cardiac Ablation (AF)	3 of 22 (13.6%)	2 of 22 (9.1%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36259713Kirstein B, Tomala J, Mayer J, Ulbrich S, Wagner M, Pu L, Piorkowski J, Hankel A, Huo Y, Gaspar T, Richter U, Hindricks G, Piorkowski C. Effect of concomitant Renal DeNervation and cardiac ablation on Atrial Fibrillation recurrence - RDN+AF study. J Cardiovasc Electrophysiol. 2023 Jan;34(1):44-53. doi: 10.1111/jce.15714. Epub 2022 Dec 1.
Individual participant dataSharing planned: No

Related trials for Persistent Atrial Fibrillation

Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Not yet recruiting
Dual-Energy Lattice-Tip Assisted Marshall-Plan Strategy in Redo Persistent Atrial Fibrillation Ablation
Atrial Fibrillation (AF)
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Recruiting
PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
Persistent 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.

Christopher Piorkowski, MD principal investigator

Herzzentrum Dresden GmbH Universitätsklinik

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Renal Artery Ablation and Cardiac Ablation in people with Persistent Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 2 sites in Germany.

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 8 inclusion and 21 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 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in 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 22 May 2020). 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?

Number of Participants With Freedom From Atrial Fibrillation at 12 Month (time frame: 12 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 NCT01907828, 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 22 May 2020.