Comparison of Percutaneous Closure to Manual Compression for Hemostasis
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|ClinicalTrials.gov Identifier: NCT04180540|
Recruitment Status : Enrolling by invitation
First Posted : November 27, 2019
Last Update Posted : May 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Percutaneous Closure Other: Manual Compression||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Comparison of Percutaneous Closure to Manual Compression for Hemostasis of Multiple Venous Access Sites Among Patients Undergoing Catheter Ablation for Atrial Fibrillation|
|Actual Study Start Date :||January 22, 2020|
|Estimated Primary Completion Date :||October 2024|
|Estimated Study Completion Date :||October 2024|
Experimental: Percutaneous Closure
Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Device: Percutaneous Closure
The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
Other Name: PerClose Proglide
Active Comparator: Manual Compression
Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Other: Manual Compression
Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without "figure of eight" suture for hemostasis at the discretion of the treating physician).
- Time to Hemostasis [ Time Frame: Day 1 ]Starting from sheath pull, time (in minutes) to hemostasis will be compared between study arms.
- Time to Ambulation [ Time Frame: Day 1 ]Time to ambulation (in minutes) following the atrial fibrillation ablation, will be compared between study arms.
- Number of Complications [ Time Frame: Day 30 ]Number of complications will be compared between study arms as a composite of all major access site complications and venous thromboembolism.
- Short-form Inguinal Pain Questionnaire Score [ Time Frame: Day 30 ]The Short-form Inguinal Pain Questionnaire is a quality of life metric where respondents report how much pain they have experienced in the past week and how pain has limited their activities. Total scores for this 2-item questionnaire ranges from 0 to 12 where higher scores indicate greater pain.
- Procedure Length [ Time Frame: Day 1 ]The length of the procedure to reach hemostasis, in minutes, will be compared between study arms.
- Patient Satisfaction [ Time Frame: Day 1 and Day 30 ]Patient satisfaction with groin access site will be assessed with a 6-item instrument where participants respond on a scale from 0 to 5 where 0 = completely satisfied and 5 = completely dissatisfied. Total scores range from 0 to 30 and lower scores indicate greater satisfaction with pain level and appearance of the access site.
- Pain Medication Needs [ Time Frame: Day 1 ]Post-procedure narcotic usage for pain medication requirements after hemostasis until discharge from the post-procedure area will be compared between study arms.
- Costs [ Time Frame: Day 30 ]Overall costs (in dollars) related to hemostasis and any complications over 30 days will be compared between study arms.
- Number of Nursing Encounters [ Time Frame: Day 1 ]The number of nursing encounters while in the post-procedure area will be compared between study arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180540
|United States, Georgia|
|Emory University Hospital Midtown|
|Atlanta, Georgia, United States, 30308|
|Emory Clinic, Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Michael Lloyd, MD||Emory University|