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

NCT ID: NCT01907828

Last Updated: 2020-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-15
• Study Completion Date: 2018-10-15

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cardiac ablation + renal artery ablation

Renal artery ablation with the EnligHTN™ Renal Denervation System

Group Type: EXPERIMENTAL

Renal Artery Ablation

Intervention Type: DEVICE

Renal artery denervation using the EnligHTN™ Renal Denervation System

Cardiac Ablation

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Cardiac Ablation

Intervention Type: 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

Interventions

Renal Artery Ablation

Renal artery denervation using the EnligHTN™ Renal Denervation System

Intervention Type: DEVICE

Cardiac Ablation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Piorkowski, MD

Role: PRINCIPAL_INVESTIGATOR

Herzzentrum Dresden GmbH Universitätsklinik

Locations

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, , Germany

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 36259713 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SJM-CIP-0009

Identifier Type: -

Identifier Source: org_study_id