N/A
Completed N=61
A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence
Source: ClinicalTrials.gov NCT01907828 ↗Enrolled (actual)
61
Serious AEs
11.5%
Results posted
May 2020
Primary outcomePrimary: Number of Participants With Freedom From Atrial Fibrillation at 12 Month — 16; 4 Participants — p=0.22
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Freedom From Atrial Fibrillation at 12 Month |
16; 4 | 0.22 |
| SECONDARY Major Adverse Cardiac Events (MACE) |
0; 2; 0; 2; 0; 2 | — |
| SECONDARY Percentage of Participants Who Experience Peri-procedural Events |
0; 1; 0; 1; 1; 0 | — |
| SECONDARY Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation |
1; 0; 2; 0; 0; 0 | — |
| SECONDARY Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months |
2.2 | 0.2766 |
| SECONDARY Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months |
-0.4 | 0.7663 |
| SECONDARY Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure. |
4; 4; 9; 5; 14; 8 | — |
| SECONDARY Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg |
4; 1 | — |
| SECONDARY Change in Ambulatory Blood Pressure at 12 Months |
-5.9; -3.1; -5.8; -8.4 | 0.0849 |
| SECONDARY Change in Ambulatory Blood Pressure at 24 Months |
-5.7; -8.6; -6.9; -10.3 | 0.1326 |
| SECONDARY Change in Office Blood Pressure at 12 Months |
2.6; 2.0; -0.4; -5.4 | 0.5399 |
| SECONDARY Change in Office Blood Pressure at 24 Months |
0.6; 7.4; 0.5; -3.0 | 0.8820 |
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) 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
Data sourced from ClinicalTrials.gov (NCT01907828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.