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Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation
NA trial testing Boston Scientific Vessix Renal Denervation System in Uncontrolled Hypertension in 50 participants. Completed in 11 July 2019.
| Lead sponsor | Vivek Reddy |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 17 September 2012 |
| Primary completion | 11 July 2019 |
| Estimated completion | 11 July 2019 |
| Sites | 8 locations across Russia, United States, Czechia |
Vivek Reddy
Adults 18 to 85, any sex, with Uncontrolled Hypertension or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary endpoint of this study is anti-arrhythmic drug (AAD)-free single-procedure freedom from AF recurrence through 12 months (not including a 90 day blanking period).
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 6 | |
| Routine Catheter Abation | 2 |
AAD-free single-procedure freedom from AF recurrence through 24 months (not-including recurrences within the first 90 days of the initial ablation procedure)
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 7 | |
| Routine Catheter Abation | 6 |
Freedom from AF recurrence through 24 months (not-including the pre-defined 90 day blanking period) despite taking AADs
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 6 | |
| Routine Catheter Abation | 5 |
Blood pressure control between the two groups as compared to baseline at 6 months, 12 months and 24 months.
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 146.6 | ± 20.6 |
| Routine Catheter Abation | 143.45 | ± 18.47 |
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 136.88 | ± 17.36 |
| Routine Catheter Abation | 142.06 | ± 78.94 |
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 137.88 | ± 17.55 |
| Routine Catheter Abation | 144.53 | ± 21.6 |
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 133.88 | ± 14.4 |
| Routine Catheter Abation | 138.7 | ± 19.9 |
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 81.46 | ± 13.4 |
| Routine Catheter Abation | 79.18 | ± 12.45 |
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 80.88 | ± 10.08 |
| Routine Catheter Abation | 78.94 | ± 7.8 |
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 82.36 | ± 9.19 |
| Routine Catheter Abation | 82.03 | ± 6.6 |
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 79.8 | ± 7.48 |
| Routine Catheter Abation | 78.87 | ± 9.75 |
Number of Participants with Major adverse cardiac events (MACE) defined as a non-weighted composite score of: death, stroke, CHF hospitalization, and clinically diagnosed thromboembolic events other than stroke and hemorrhage requiring transfusion within 12 months of randomization
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 0 | |
| Routine Catheter Abation | 1 |
SAE-any experience that results in a fatality or is life threatening; results in significant or persistent disability; requires or prolongs hospitalization; results in congenital anomaly/birth defect; or represents other significant hazards or potentially serious harm to research subjects or others, in the opinion of the investigators. Important medical events that may not result in above may be considered a SAE when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 5 | |
| Routine Catheter Abation | 1 |
LA size by TTE at baseline and at 12 months
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 5.4 | ± 0.8 |
| Routine Catheter Abation | 4.7 | ± 1.3 |
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 5.19 | ± 0.9 |
| Routine Catheter Abation | 4.68 | ± 1.4 |
Ejection fraction (EF) is a measurement, expressed as a percentage, of how much blood the left ventricle pumps out with each contraction. A normal heart's ejection fraction may be between 50 and 70 percent.
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 62.52 | ± 6.88 |
| Routine Catheter Abation | 63.84 | ± 6.25 |
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 62.9 | ± 7.21 |
| Routine Catheter Abation | 64.5 | ± 4.53 |
Causality will be defined as adverse events that, after careful medical evaluation, are considered with a high degree of certainty to be related to the intervention (AF ablation ± renal sympathetic denervation).
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 6 | |
| Routine Catheter Abation | 1 |
Total number of anti-hypertensive medications at study end, compared between the two treatment arms
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 2.8 | ± 0.95 |
| Routine Catheter Abation | 2.5 | ± 1.0 |
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 2.8 | ± 1.0 |
| Routine Catheter Abation | 2.35 | ± 1.0 |
The change in quality of life (QoL) from baseline to 12 months as measured by AFEQT, a 20- item instrument. Full range from 0 to 100, with higher score indicates higher level of QoL.
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 72.75 | ± 22.85 |
| Routine Catheter Abation | 75.4 | ± 26.54 |
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 37.95 | ± 16.13 |
| Routine Catheter Abation | 30 | ± 11.58 |
| Group | Value | 95% CI |
|---|---|---|
| Renal Sympathetic Denervation PLUS Catheter Ablation | 39.8 | ± 20.32 |
| Routine Catheter Abation | 36.57 | ± 21.1 |
Time frame: 24 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Catheter Ablation of Atria… | Routine Catheter Abation |
|---|---|---|---|
| Femoral Pseudoaneurysm | Vascular disorders | — | — |
| Urinary Retention | Renal and urinary disorders | — | — |
| Bleeding | Blood and lymphatic system disorders | — | — |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Cardiac Arrhythmia | Congenital, familial and genetic disorders | — | — |
| Enlarged Prostate | Renal and urinary disorders | — | — |
| Esophageal Ulcer | Gastrointestinal disorders | — | — |
| Fever | Immune system disorders | — | — |
| Gastroenteritis | Gastrointestinal disorders | — | — |
| Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Neutropenic fever | Immune system disorders | — | — |
| Pulmonary Edema | General disorders | — | — |
| Renal Dysfunction | Renal and urinary disorders | — | — |
| Reaction | System | Catheter Ablation of Atria… | Routine Catheter Abation |
|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Aortic Aneurysm Dissection | Cardiac disorders | — | — |
| Atypical Chest Pain | Musculoskeletal and connective tissue disorders | — | — |
| Blurred vision | Eye disorders | — | — |
| Groin Hematoma | Skin and subcutaneous tissue disorders | — | — |
| Hematoma | Skin and subcutaneous tissue disorders | — | — |
| Hemoptysis | Gastrointestinal disorders | — | — |
| Neck Pain | Musculoskeletal and connective tissue disorders | — | — |
| Syncope | General disorders | — | — |
Most-reported serious reactions: Femoral Pseudoaneurysm, Urinary Retention, Bleeding, Breast Cancer, Cardiac Arrhythmia, Enlarged Prostate, Esophageal Ulcer, Fever.
Data from ClinicalTrials.gov NCT01635998 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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