N/A
N=50
Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation
Uncontrolled Hypertension · Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01635998 ↗Enrolled (actual)
50
Serious AEs
32.0%
Results posted
Nov 2020
Primary outcome: Primary: Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence — 6; 2 recurrences
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Boston Scientific Vessix Renal Denervation System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vivek Reddy
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence |
6; 2 | — |
| SECONDARY AAD-free Single-procedure Freedom From AF Recurrence |
7; 6 | — |
| SECONDARY Freedom From AF Recurrence Despite Taking AADs |
6; 5 | — |
| SECONDARY Blood Pressure Control as Compared to Baseline |
146.6; 143.45; 136.88; 142.06; 137.88; 144.53 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac Events (MACE) |
0; 1 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAE) |
5; 1 | — |
| SECONDARY Left Atrial (LA) Size |
5.4; 4.7; 5.19; 4.68 | — |
| SECONDARY Ejection Fraction (EF) |
62.52; 63.84; 62.9; 64.5 | — |
| SECONDARY Number of Participants With Procedure Adverse Events |
6; 1 | — |
| SECONDARY Number of Anti-hypertensive Medications |
2.8; 2.5; 2.8; 2.35 | — |
| SECONDARY Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT) |
72.75; 75.4; 37.95; 30; 39.8; 36.57 | — |
Summary
The objective of the H-FIB trial is to determine the role of renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.
Eligibility Criteria
Inclusion Criteria
- Inclusion Criteria
- Age ≥ 18 years of age
- History of AF (paroxysmal or persistent) and planned for a guideline-supported catheter ablation procedure
- History of significant hypertension (defined as SBP ≥160 mm Hg and/or DBP ≥100 mmHg) and receiving treatment with at least one anti-hypertensive medication OR Clinical History of hypertension and receiving treatment with at least two anti-hypertensive medications (specifically for blood pressure reduction).
- Renal vasculature is accessible as determined by intra-procedural renal angiography.
- Ability to understand the requirements of the study
- Willingness to adhere to study restrictions, comply with all post-procedural follow-up requirements and to sign informed consent
Exclusion Criteria
- Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
- Prior left atrial ablation for an atrial arrhythmia (before this index procedure)
- Patients with NYHA class IV congestive heart failure
- Individual has known secondary hypertension
- Individual has renal artery anatomy that is ineligible for treatment including:
- Inability to access renal vasculature
- Main renal arteries < 3 mm in diameter or < 20 mm in length.
- Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets standards for surgical repair or interventional dilation.
- A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment.
- Individual has an estimated glomerular filtration rate (eGFR) of less than 45mL/min/1.73m2, using the MDRD calculation.
- Individual has a single functioning kidney (either congenitally or iatrogenically).
- Individual is pregnant or nursing.
- Life expectancy <1 year for any medical condition
Data sourced from ClinicalTrials.gov (NCT01635998). 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.