COMPANY
Volta Medical
Timeline
- Trial start Not phased (device or behavioral study): Use of Volta Medical AI-software During Atrial Fibrillation Ablation to Identify Patients Who May Need More Than Pulmonary Vein Isolation. source ↗
- Trial start —: VOLta Medical AI-software in REal-World During AF Ablation source ↗
- FDA FDA 510(k) clearance: Volta AF-Xplorer II — K251518, Sep 12, 2025. Applicant at approval: Volta Medical. source ↗
- FDA FDA 510(k) clearance: Volta AF-Xplorer — K243812, May 9, 2025. Applicant at approval: Volta Medical. source ↗
- Trial start —: Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation source ↗
- Trial start —: Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation source ↗
- Trial start —: Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation source ↗
- Trial start Not phased (device or behavioral study): Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion source ↗
- Trial start Not phased (device or behavioral study): AutoMatic disPERsion Tagging Function Preliminary Evaluation source ↗
- Trial start Not phased (device or behavioral study): Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation source ↗
Upcoming milestones
- Apr 27, 2027 (ESTIMATED) · · Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation · NCT06083012
- 2027-12 (ESTIMATED) · · Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation · NCT06056271
- Dec 31, 2027 (ESTIMATED) · · Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation · NCT06825104
- 2028-02 (ESTIMATED) · Not phased · Use of Volta Medical AI-software During Atrial Fibrillation Ablation to Identify Patients Who May Need More Than Pulmonary Vein Isolation. · NCT07807423
- 2030-06 (ESTIMATED) · · VOLta Medical AI-software in REal-World During AF Ablation · NCT07621055
Clinical trials (lead sponsor) 8
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07807423 | Use of Volta Medical AI-software During Atrial Fibrillation Ablation to Identify Patients Who May Need More Than Pulmonary Vein Isolation. | Not phased (device or behavioral study) | Recruiting | Sep 22, 2026 | 2028-02 (estimated) |
| NCT07621055 | VOLta Medical AI-software in REal-World During AF Ablation | Not listed | Recruiting | Jun 16, 2026 | 2030-06 (estimated) |
| NCT06083012 | Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation | Not listed | Active, not recruiting | Oct 27, 2023 | Apr 27, 2027 (estimated) |
| NCT06056271 | Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation | Not listed | Recruiting | Mar 19, 2024 | 2027-12 (estimated) |
| NCT05477147 | Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion | Not phased (device or behavioral study) | Completed | Mar 17, 2023 | May 7, 2025 (actual) |
| NCT04702451 | Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation | Not phased (device or behavioral study) | Completed | Feb 12, 2021 | Dec 27, 2023 (actual) |
| NCT06825104 | Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation | Not listed | Recruiting | Mar 6, 2025 | Dec 31, 2027 (estimated) |
| NCT05362656 | AutoMatic disPERsion Tagging Function Preliminary Evaluation | Not phased (device or behavioral study) | Completed | May 29, 2022 | Dec 9, 2022 (actual) |
FDA records (last 2 years)
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