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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01907828
First received: July 17, 2013
Last updated: September 19, 2016
Last verified: September 2016
  Purpose
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

Condition Intervention
Persistent Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Hypertension
Device: Renal Artery Ablation
Device: Cardiac Ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Freedom from atrial fibrillation in patients with hypertension [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major adverse cardiac events [ Time Frame: 7 days, 6 months, and 12 months post procedure ] [ Designated as safety issue: Yes ]
  • Percent of patients who experience a procedural related event [ Time Frame: 30 days post procedure ] [ Designated as safety issue: Yes ]
  • Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: Yes ]
  • Renal function change based on eGFR (renal denervation group only) [ Time Frame: 6 months,12 months ] [ Designated as safety issue: Yes ]
  • Recurrence of AF based on electrocardiographic data up to 2 years following the initial cardiac ablation procedure. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Percentage of subjects achieving office Systolic Blood Pressure < 140 [ Time Frame: 6 months post procedure ] [ Designated as safety issue: No ]
  • Change in Office and Ambulatory Blood Pressure parameters [ Time Frame: 6 month, 12 month, 24 month post procedure ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: July 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cardiac ablation + renal artery ablation
Renal artery ablation with the EnligHTN™ Renal Denervation System
Device: Renal Artery Ablation
Renal artery denervation using the EnligHTN™ Renal Denervation System
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
Active Comparator: Cardiac ablation
Cardiac ablation
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01907828

Locations
Germany
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, Germany, 01307
Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Christopher Piorkowski, MD Herzzentrum Dresden GmbH Universitätsklinik
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01907828     History of Changes
Other Study ID Numbers: SJM-CIP-0009 
Study First Received: July 17, 2013
Last Updated: September 19, 2016
Health Authority: Germany: Ethics Commission
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on September 23, 2016