Table 1.
Ongoing clinical trials evaluating autonomic therapies for AF
| Intervention | Target | Trial design | Disease | n | ClinicalTrials.gov identifier | Description |
|---|---|---|---|---|---|---|
| GP ablation | GPs | RCT | AF | 60 | NCT03535818 | Adjunctive Ganglionated Plexus Ablation in Redo-PVI (ADD-GP); testing efficacy of GP ablation in patients with paroxysmal or persistent AF undergoing redo PVI for recurrent paroxysms of arrhythmia |
| GP ablation | GPs | RCT | POAF | 62 | NCT02035163 | AF Prevention in Post-Coronary Artery Bypass Graft Surgery with Cryoablation for Ganglionic Plexi; evaluating cryoablation of GPs during cardiac surgery to prevent POAF |
| GP ablation | GPs | RCT | AF | 180 | NCT02487654 | Ectopy-Triggering GP Ablation to Prevent AF (GANGLIA-AF); evaluating GP ablation alone vs. PVI alone |
| GP ablation | GPs | Single-arm feasibility | AF | 16 | NCT04642976 | Prospective Evaluation of CT-Guided Ablation of Cardiac GPs; evaluating feasibility and efficacy of CT-guided GP localization to guide AF ablation |
| Botulinum toxin | GPs | RCT | POAF | 330 | NCT03779841 | Botulinum Toxin Type A (AGN-151607) for the Prevention of POAF in Patients Undergoing Open-chest Cardiac Surgery (NOVA); evaluating epicardial fat pad injection of botulinum toxin A to prevent post-operative AF |
| Botulinum toxin | GPs | RCT | POAF | 220 | NCT04075981 | Prevention AF by BOTulinum Toxin Injections (BOTAF) ; evaluating botulinum toxin injection into epicardial fat pads during cardiac surgery to reduce POAF |
| LLVNS | Tragus | RCT | POAF | 266 | NCT04514757 | Transcutaneous (Tragus) Vagal Nerve Stimulation for POAF (tVNS_POAF); evaluating low-level tragus stimulation for POAF |
| LLVNS | Tragus | RCT | POAF | 80 | NCT03392649 | Tragus Stimulation to Prevent AF After Cardiac Surgery (TraP-AF); evaluating low-level tragus vagal nerve stimulation for POAF |
| LLVNS | Tragus | RCT | HRV, MAST | 90 | NCT04682704 | The Effect of Different Low-Level Tragus Stimulation Parameters On Autonomic Nervous System Function (LLT-SPANS); evaluating different stimulation parameters on the autonomic nervous system |
| RDN | Renal nerves | RCT | AF | 40 | NCT03246568 | Renal Nerve Denervation After Pulmonary Vein Isolation for Persistent AF; evaluating the effect of RDN in addition to PVI for persistent AF |
| RDN | Renal nerves | RCT | AF | 130 | NCT04182620 | Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During AF Ablation (ULTRA-HFIB); evaluating RDN as adjunctive treatment for patients undergoing PVI for AF |
| RDN | Renal nerves | RCT | AF | 100 | NCT01686542 | CPVI Plus Renal Sympathetic Modification Versus CPVI Alone for AF Ablation; evaluating RDN as adjunctive treatment for patients undergoing PVI for AF |
| RDN | Renal nerves | RCT | AF | 138 | NCT02115100 | Treatment of AF in Patients by PVI in Combination With Renal Denervation or PVI Only (ASAF); evaluating RDN as adjunctive treatment for patients undergoing PVI for AF and resistant hypertension |
| RDN | Renal nerves | RCT | AF | 50 | NCT01635998 | Adjunctive Renal Denervation in the Treatment of AF (H-FIB); evaluating adjunctive RDN in patients with hypertension undergoing PVI for AF |
| RDN | Renal nerves | RCT | AF | 100 | NCT01990911 | Renal Sympathetic Denervation Prevents AF in Patients With Hypertensive Heart Disease: a Pilot Study (RDPAF); evaluating whether RDN in patients with hypertensive heart disease reduces new-onset AF |
| RDN | Renal nerves | RCT | AF | 61 | NCT01907828 | A feasibility study to evaluating the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence (RDN+AF); evaluating adjunctive RDN in patients with paroxysmal or persistent AF and uncontrolled hypertension. |
AF indicates atrial fibrillation; CPVI, circumferential pulmonary vein isolation; GP, ganglionated plexus; LLVNS, low-level vagal nerve stimulation; POAF, post-operative atrial fibrillation; RCT, randomized controlled trial; PVI, pulmonary vein isolation; RDN, renal denervation.