NCT07820631Not yet recruiting
First-in-Human Study of the Circle Safe System for Diaphragm Response Monitoring During Pulmonary Vein Ablation
Evaluation of the Safety and Effectiveness of the Circle SAFE System for Diaphragmatic Compound Motor Action Potential (CMAP) Recording and Display of Patients Undergoing Pulmonary Vein Ablation Procedures. The SAFE-CMAP Clinical Trial
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
The objective of this first-in-human study is to evaluate the safety and performance of the Circle Safe System in subjects undergoing pulmonary vein ablation for atrial fibrillation. The main questions it aims to answer are: * Can the Circle Safe System consistently stimulate the phrenic nerve and record a stable electrical response from the diaphragm? * Can it reliably display changes in the diaphragm's response during ablation? * What device-related or procedure-related medical problems occur during the study? There is no comparison group. All participants will undergo their planned pulmonary vein ablation while the Circle Safe System is used during treatment of the right pulmonary veins. Participants will: * Complete standard assessments before the procedure * Have the Circle Safe catheter placed in the superior vena cava during the ablation procedure * Have their phrenic nerve stimulated and their diaphragm response monitored using the Circle Safe System * Be evaluated for device-related and procedure-related safety events through hospital discharge
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 22 Jul 2026
- Start date
- 17 Aug 2026
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Circle Safe, Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT07820631
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 17 Aug 2026 to the primary completion date, 31 Oct 2026
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with inadequate venous access due to prior vein thrombosis or indwelling chronic ports or catheters
Other illness
- Subjects with known neuromuscular disease or other medical history (i.e trauma, surgery) that could have impacted diaphragmatic function
Other
- Subjects with pacemaker or defibrillator leads placed through the vena cava
- Subjects with implantable vena cava filter
- Subjects with a contraindication to contrast dye
- Pregnant subjects
- Subjects participating in another clinical trial that has not reached the follow-up time point to primary endpoint assessment
Who the study is looking for
- Male or females \>18 and ≤ 85 years of age
- Subject willing to sign informed consent
- Subject is a candidate for pulmonary vein ablation for the treatment of atrial fibrillation ablation procedures therapy
Age in the registry: 19 years to 84 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Timone - APHM Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hôpital Cardiologique du Haut Lévèque Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Auckland City Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.