AMBULATE Same Day Discharge Registry

NCT04203329 | Unknown FDA Device

• 1 other identifier: PTL 0601
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 15

Brief Summary

A multi-center, prospective, single-arm post market registry, designed to collect both performance and complication outcomes when same day discharge is enabled by the study device, in sealing multiple femoral venous access sites at the completion of ablation procedures for atrial fibrillation with or without another arrhythmia, performed through 6 - 12 Fr inner diameter (maximum 15F OD) introducer sheaths.

Conditions

Vascular Closure

Outcome Measures

Primary Outcomes (2)

• VASCADE MVP VVCS Procedure Success

  Patients do not require next day hospital intervention\* due to access site-related complications.

  1 day

• Major Complication Rate

  On a per-limb basis, the rate of combined major venous access site closure-related complications attributed directly to the closure method within 15 ± 5 days of discharge (i.e., "device-related" with no other likely attributable cause).

  15 Days +/- 5 Days

Secondary Outcomes (4)

• Same Day Procedure Success

  1 day

• Sustained VASCADE MVP VVCS Procedure Success

  15 Days +/- 5 Days

• Device Success

  intra-procedural

• Minor Complication Rate

  15 Days +/- 5 Days

Study Arms (3)

Paroxysmal A-Fib

Device: Femoral Venous Vascular Closure

Persistent A-Fib

Device: Femoral Venous Vascular Closure

A-Fib

Device: Femoral Venous Vascular Closure

Interventions

Femoral Venous Vascular Closure DEVICE

Femoral venous vascular closure following catheter-based cardiac ablation a-fib cases utilizing 6-12 French inner diameter procedural sheaths at time of closure.

A-Fib; Paroxysmal A-Fib; Persistent A-Fib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing ablation procedures for atrial fibrillation with or without another arrhythmia, performed through 6 - 12 Fr inner diameter (maximum 15F OD) introducer sheaths.

You may qualify if:

• ≥18 years of age;
• Capable and willing to give informed consent;
• Acceptable candidate for an elective, non-emergent catheter-based paroxysmal atrial fibrillation ablation procedure with or without another arrhythmia via the common femoral vein(s) using a 6 to 12 Fr inner diameter (max 15F OD) introducer sheath
• Is accompanied by a person who will be available to assist the subject for 24 hours post-procedure and/or has access to emergency services;
• Is willing/able to stay overnight at the hospital per physician discretion.
• Able and willing to complete two follow-up contacts at 2-4 days and 15 (± 5) days post-procedure.
• Acceptable candidate for emergent vascular surgery, and/or manual compression of the venous access site;
• All criteria apply:
• In the Investigator's opinion, the subject is a candidate for Same Day Discharge per protocol (e.g., no new pericardial effusion, post-procedure diuresis not needed, etc.).
• Physician or designee will be on site for discharge evaluation.
• Case completed in time for subject to be reasonably recovered and discharged according to protocol.
• All femoral venous access sites are planned to be closed with the MVP
• Note:
• Initial subject eligibility will be determined based on pre-operative screening.

You may not qualify if:

• Subjects will be excluded from participating in this study if they meet any of the following criteria prior to initiation of the index procedure:
• Advanced refusal of blood transfusion, if it should become necessary;
• Active systemic infection, or cutaneous infection or inflammation in the vicinity of the groin;
• Pre-existing immunodeficiency disorder and/or chronic use of high dose systemic steroids;
• Known history of bleeding diathesis, coagulopathy, hypercoagulability, or current platelet count \< 100,000 cells/mm3;
• Severe co-existing morbidities, with a life expectancy of less than 12 months;
• Currently involved in any clinical trial that may interfere with the outcomes of this study in the opinion of investigator;
• Femoral arteriotomy in either limb with any of the following conditions:
• access within \< 10 days
• any residual hematoma, significant bruising, or known associated vascular complications
• use of a vascular closure device within the previous 30 days;
• Femoral venotomy in either limb with any of the following conditions:
• access within \< 10 days
• any residual hematoma, significant bruising, or known associated vascular complications
• use of a vascular closure device

Sponsors & Collaborators

• Cardiva Medical, Inc.: lead

Study Sites (15)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

HonorHealth

Scottsdale, Arizona, 85260, United States

Location

Coastal Cardiology

San Luis Obispo, California, 93401, United States

Location

Aurora Denver Cardiology Associates, The Medical Center of Aurora

Aurora, Colorado, 80012, United States

Location

MedStar Washington

Washington D.C., District of Columbia, 20010, United States

Location

Emory St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Wake Med Hospital

Raleigh, North Carolina, 27610, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Texas Cardiac Arrhythmia Institute

Austin, Texas, 78705, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Medical City Fort Worth

Fort Worth, Texas, 76104, United States

Location

University of Utah Health

Salt Lake City, Utah, 84132, United States

Location

Chippenham Hospital

Richmond, Virginia, 23225, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 18, 2019
• Study Start: June 30, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)