Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a prospective, multicenter, randomized controlled trial with a non-inferiority design. Participants are patients scheduled for atrial septal puncture. After signing informed consent, subjects will be randomly assigned to either the radiofrequency transseptal puncture system group (referred to as the trial group) or the traditional mechanical transseptal puncture system group (referred to as the control group). All participants will undergo immediate postoperative and discharge clinical follow-ups.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency transseptal puncture needle | Experimental | Utilizing Radiofrequency transseptal puncture system for left atrial access |
|
| Traditional mechanical transseptal puncture needle | Active Comparator | Utilizing Traditional mechanical transseptal puncture needle for left atrial access |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AThrough radiofrequency transseptal puncture system | Device | Utilizing AThrough radiofrequency transseptal puncture system for left atrial access |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transseptal puncture success rate. | Defined as successfully completing the puncture in the atrial septum and establishing a pathway from the right atrium to the left atrium (with the sheath entering the left atrium) using the transseptal puncture system | Intraprocedural assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Initial transseptal puncture success rate. | Defined as the period from the introduction of the transseptal puncture system into the femoral vein to the entry of transseptal sheath into the left atrium. | Intraprocedural assessment |
| Time required to successfully complete the transseptal puncture. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wei Sun, MD | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 7th People's Hospital of Zhengzhou | Zhengzhou | Henan | 450000 | China | ||
| The First Affiliated Hospital with Nanjing Medical University |
Not provided
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Traditional mechanical transseptal puncture needle | Device | Utilizing Traditional mechanical transseptal puncture needle for left atrial access |
|
Defined as the time from when the transseptal puncture system is introduced into the femoral vein to when the transseptal sheath enters the left atrium. |
| Intraprocedural assessment |
| Number of attempts needed to successfully complete the transseptal puncture. | During the transseptal puncture process, if the transseptal puncture system needs to be readjusted upwards and repositioned for oval fossa puncture, each readjustment should count as an additional attempt. | Intraprocedural assessment |
| Ratio of atrial septal puncture failures that cross over to the opposite group. | Ratio of atrial septal puncture failures that cross over to the opposite group; | Intraprocedural assessment |
| Nanjing |
| Jiangsu |
| 210000 |
| China |
| Tianjin Chest Hospital | Tianjin | Tianjin Municipality | China |
| The First Affiliated Hospital of Ningbo University | Ningbo | Zhejiang | 315000 | China |