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

NCT01907828 | Completed Results

• 1 other identifier: SJM-CIP-0009
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief 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 treated for Atrial Fibrillation

Conditions

Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (11)

• Major Adverse Cardiac Events (MACE)

  7 days, 6 months, 12 months, and 24 months post procedure

• Percentage of Participants Who Experience Peri-procedural Events

  30 days post procedure

• Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation

  6 months and 12 months post procedure

• Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months

  Baseline and 6 months

• Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months

  Baseline and 12 months

Study Arms (2)

Cardiac ablation + renal artery ablation

EXPERIMENTAL

Renal artery ablation with the EnligHTN™ Renal Denervation System

Device: Renal Artery Ablation; Device: Cardiac Ablation

Cardiac ablation

ACTIVE COMPARATOR

Cardiac ablation

Device: Cardiac Ablation

Interventions

Renal Artery Ablation DEVICE

Renal artery denervation using the EnligHTN™ Renal Denervation System

Cardiac ablation + renal artery ablation

Cardiac Ablation DEVICE

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

Cardiac ablation; Cardiac ablation + renal artery ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (2)

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, 01307, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Related Publications (1)

• 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.

  PMID: 36259713 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Rebecca Maslow, MA, Clinical Project Manager
• Organization: Abbott

rebecca.maslow@abbott.com

+1 651-756-5564

Study Officials

• Christopher Piorkowski, MD

  Herzzentrum Dresden GmbH Universitätsklinik

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 25, 2013
• Study Start: April 15, 2014
• Primary Completion: October 15, 2018
• Study Completion: October 15, 2018
• Last Updated: May 22, 2020
• Results First Posted: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)