NCT06793969|Recruiting
Loading search results
Sponsor study identifier
interventional
120
1 country
1
Study Start
December 24, 2023
Actual (reported)Primary Completion
March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The technical challenge in patent foramen ovale (PFO) closure lies in successfully establishing an occlusion pathway through the PFO tunnel using a guidewire or catheter. In this study, we aim to investigate the efficacy and safety of Swartz sheath with angioplasty guidewire-assisted technique for PFO Closure.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 24, 2023
Actual (reported)January 21, 2025
Actual (reported)January 27, 2025
Actual (reported)March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Time of PFO tunnel passage
The total time required to pass the guide across PFO tunnel
Intraprocedural assessment (measured in minutes )
Procedure Time
Intraprocedural assessment (measured in minutes )
Fluoroscopy Time
Intraprocedural assessment (measured in minutes )
Procedural Complications
Intraprocedural assessment
Radiation Dose
Intraprocedural assessment (measured in mGys)
In the conventional group, the PFO closure procedure is performed with a multi-functional catheter and guided by intraprocedural fluoroscopy and intracardiac echocardiography (ICE).
In the Swartz sheath + angioplasty guidewire group, the PFO closure procedure is performed with Swartz sheath + angioplasty guidewire assistance and guided by intraprocedural fluoroscopy and ICE.
The angioplasty guidewire is advanced into the left atrium and left superior pulmonary vein (LSPV). The Swartz sheath is then delivered to the left atrium along the 0.014" guidewire through the PFO. Next, the Runthrough guidewire is changed to a 0.035" J-tipped guidewire, which is advanced into the LSPV. Finally, the delivery sheath for the PFO closure device is introduced to the left atrium along the guidewire, and all other toolkits are withdrawn.
Renji Hospital
Shanghai, 200127, China
First Submitted
January 21, 2025
First Posted
January 27, 2025
Study Start
December 24, 2023
Actual (reported)Primary Completion
March 30, 2025
Estimated (date passed)In the conventional group, the PFO closure procedure is performed with a multi-functional catheter and guided by intraprocedural fluoroscopy and ICE
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 27, 2025
Record last verified: 2025-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: