Stitch or device? trial tests which groin closure leaves heart patients more comfortable
NCT ID NCT07814144
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Doctors close the groin vein puncture after atrial fibrillation ablation either with a suture-based device called Perclose ProGlide or with a traditional figure-of-8 stitch. This trial randomly assigns 90 adults to one of the two methods and asks them how satisfied they are with the closure. Researchers also track how quickly bleeding stops, how soon participants can walk, when they go home, and whether any vascular complications appear within 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Perclose ProGlide suture-based venous closure device
- What this could lead to
- If the device proves more comfortable and faster than a stitch, it could become a routine way to close groin vein access after heart rhythm procedures.
- What could go wrong
- This is a small, single-center study of 90 people, so its results may not hold for other hospitals or patients. Both methods are already used in practice, and the main measure is a satisfaction questionnaire rather than a hard clinical outcome.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
90 people
The number who actually took part.
- Started
-
Jan 2026
- Expected to finish
-
Aug 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥19 years or legal age to provide informed consent under Korean law. 2. Scheduled for atrial fibrillation catheter ablation using unilateral femoral venous access with a sheath ≥8 Fr. 3. Bilateral femoral venous anatomy suitable for application of the Perclose ProGlide™ suture-based vascular closure device. 4. Written informed consent and agreement to post-procedural follow-up and outpatient visits. 5. Considered able to complete follow-up during the study period. Exclusion Criteria: 1. History of prolonged hospitalization due to vascular access-related complications. 2. History of vascular surgery involving the lower extremities or aorto-iliac axis. 3. Bleeding tendency (e.g., coagulation disorder or bleeding diathesis) or abnormal coagulation state (e.g., hypercoagulable state). 4. Platelet count \<100,000/mm³. 5. History of deep vein thrombosis, pulmonary embolism, or thrombophlebitis. 6. Moderate or greater anemia (hemoglobin ≤10 g/dL). 7. Hemodynamic or electrical instability. 8. Body mass index \>45 kg/m² or \<20 kg/m². 9. Severe renal impairment (eGFR \<30 mL/min/1.73 m²), except for patients receiving renal replacement therapy. 1\. History of prolonged hospitalization due to vascular access-related complications. 2\. History of vascular surgery involving the lower extremities or aorto-iliac axis. 3\. Bleeding tendency (e.g., coagulation disorder or bleeding diathesis) or abnormal coagulation state (e.g., hypercoagulable state). 4\. Platelet count \<100,000/mm³. 5. History of deep vein thrombosis, pulmonary embolism, or thrombophlebitis. 6. Moderate or greater anemia (hemoglobin ≤10 g/dL). 7. Hemodynamic or electrical instability. 8. Body mass index \>45 kg/m² or \<20 kg/m². 9. Severe renal impairment (eGFR \<30 mL/min/1.73 m²), except for patients receiving renal replacement therapy.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Atrial fibrillation are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Yonsei University College of Medicine
Seoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can exercise tame atrial fibrillation? trial tests workouts on heart rhythm and fitness
- Pacemaker lead position may cut heart rhythm complication
- Can zapping the heart beat drugs for AF in heart failure?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Stroke's hidden heart rhythm clue under investigation