Clinical trial NCT04203329: AMBULATE Same Day Discharge Registry
Official title: A Multi-center, Prospective, Single Arm Registry to Evaluate Procedural Outcomes Using the Cardiva VASCADE MVP VVCS Closure Device After Catheter-based Atrial Fibrillation Interventions for Patients Who Are Discharged the Same Day.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vascular Closure
Lead sponsor: Cardiva Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-18
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Group 1 Paroxysmal AF

Inclusion Criteria:

Pre-Operative Inclusion:

All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:

1. ≥18 years of age;
2. Capable and willing to give informed consent;
3. 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
4. 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;
5. Is willing/able to stay overnight at the hospital per physician discretion.
6. Able and willing to complete two follow-up contacts at 2-4 days and 15 (± 5) days post-procedure.
7. Acceptable candidate for emergent vascular surgery, and/or manual compression of the venous access site;

Intra-Operative Inclusion:

All criteria apply:

1. 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.).
2. Physician or designee will be on site for discharge evaluation.
3. Case completed in time for subject to be reasonably recovered and discharged according to protocol.
4. 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.

Final subject enrollment will be determined at the end the procedure, prior to closure, based on general intra-op exclusion criteria, as well as additional intraoperative criteria. Enrollment is thus determined intra-operatively, at the end of the case and just prior to closure.

Exclusion Criteria:

Pre-Operative Exclusion:

Subjects will be excluded from participating in this study if they meet any of the following criteria prior to initiation of the index procedure:

1. Advanced refusal of blood transfusion, if it should become necessary;
2. Active systemic infection, or cutaneous infection or inflammation in the vicinity of the groin;
3. Pre-existing immunodeficiency disorder and/or chronic use of high dose systemic steroids;
4. Known history of bleeding diathesis, coagulopathy, hypercoagulability, or current platelet count \< 100,000 cells/mm3;
5. Severe co-existing morbidities, with a life expectancy of less than 12 months;
6. Currently involved in any clinical trial that may interfere with the outcomes of this study in the opinion of investigator;
7. Femoral arteriotomy in either limb with any of the following conditions:

   1. access within \< 10 days
   2. any residual hematoma, significant bruising, or known associated vascular complications
   3. use of a vascular closure device within the previous 30 days;
8. Femoral venotomy in either limb with any of the following conditions:

   1. access within \< 10 days
   2. any residual hematoma, significant bruising, or known associated vascular complications
   3. use of a vascular closure device
9. Any planned procedure involving femoral arterial or venous access in either limb within the next 30 days;
10. Any history of deep vein thrombosis, pulmonary embolism or thrombophlebitis;
11. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
12. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or who are lactating;
13. Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2);
14. Unable to routinely walk at least 20 feet without assistance;
15. Known allergy/adverse reaction to bovine derivatives;
16. Administration of low molecular weight heparin (LMWH) within 8 hours before or after the procedure;
17. Planned procedures or concomitant condition(s) that may extend ambulation attempts beyond routine ambulation and/or hospital discharge time (e.g., staged procedure, serious co-morbidity, uncontrolled obstructive sleep apnea, congestive heart failure), in the opinion of the Investigator.
18. Current diagnosis of persistent or permanent atrial fibrillation.

General Intra-op Exclusion Criteria:

Subjects will be excluded from participating in this study if any of the following exclusion criteria occur during the index procedure:

1. Any attempt at femoral arterial access during the procedure;
2. Any procedural complications that may extend routine recovery, ambulation and discharge times;
3. If the physician deems that a different method should be used to achieve hemostasis of the venous access sites, or that the subject should not attempt ambulation according to the protocol requirements;
4. All venous access sites must are subject to the following exclusion criteria, assessed immediately prior to enrollment:

   1. Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, accidental arterial stick with hematoma, "back wall stick", etc.) in any of the study veins;
   2. A procedural sheath \< 6 Fr or \> 12 Fr in inner diameter is present at time of closure;
   3. Venous access site location is noted to be "high", above the inguinal ligament (cephalad to lower half of the femoral head or the inferior epigastric vein origin from the external iliac vein);
   4. Intra-procedural bleeding around sheath, or suspected intraluminal thrombus, hematoma, pseudoaneurysm, or AV fistula;
   5. Length of the tissue tract, the distance between the anterior venous wall and skin, is estimated to be less than 2.5 cm.

Discharge Evaluation Criteria

1. Physician or designee must perform discharge evaluation.
2. Subject has successfully ambulated without bleeding from access site.
3. Subject has been able to void.
4. No clinically significant ECG findings.
5. Subject is accompanied by a responsible person who will be near them for the next 24 hours. Subjects must meet all Discharge Criteria in order to be eligible for same day discharge at physician discretion.

Group 2 Persistent A-Fib Pre-Operative Inclusion Criteria All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:

1. ≥18 years of age;
2. Capable and willing to give informed consent;
3. Acceptable candidate for an elective, persistent atrial fibrillation ablation procedure;
4. Acceptable candidate planned for same day discharge;
5. Able and willing to complete two follow-up contacts at 2-4 days and 15 (± 5) days post-procedure.

Pre-Operative Exclusion Criteria Subjects will be excluded from participating in this study if they meet any of the following criteria prior to initiation of the index procedure:

1. In the index limb(s): Active systemic infection, or cutaneous infection;
2. Known history of bleeding diathesis, coagulopathy, hypercoagulability, or current platelet count \< 100,000 cells/mm3;
3. Currently involved in any clinical trial that may interfere with the outcomes of this study in the opinion of investigator;
4. Femoral catheterization procedure in any study limb in the previous 30 days;
5. Any planned procedure involving femoral arterial or venous access in either limb within the next 30 days;
6. History of deep vein thrombosis, pulmonary embolism or thrombophlebitis in the last 12 months;
7. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or who are lactating;
8. Unable to routinely walk at least 20 feet without assistance;
9. Known allergy/adverse reaction to bovine derivatives;
10. Planned procedures or concomitant condition(s) that may extend ambulation attempts beyond routine ambulation and/or hospital discharge time (e.g., staged procedure, serious co-morbidity, uncontrolled obstructive sleep apnea, congestive heart failure, extreme morbid obesity), in the opinion of the Investigator.

Intra-Operative Inclusion Criteria

All criteria apply:

1. In the Investigator's opinion, the subject is a candidate for Same Day Discharge per protocol (no procedure related events/complications e.g., no new pericardial effusion, post-procedure diuresis not needed, etc.).
2. Case completed in time for subject to be reasonably recovered and discharged according to protocol.
3. 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.

Final subject enrollment will be determined at the end the procedure, prior to closure, based on general intra-op exclusion criteria, as well as additional intraoperative criteria. Enrollment is thus determined intra-operatively, at the end of the case and just prior to closure.

Intra-Operative Exclusion Criteria Subjects will be excluded from participating in this study if any of the following exclusion criteria occur during the index procedure:

1. Any attempt at femoral arterial access during the procedure;
2. In the index limb(s): infection or inflammation in the vicinity of the groin
3. Administration of low molecular weight heparin (LMWH) within 8 hours before or after the procedure;
4. All venous access sites must are subject to the following exclusion criteria, assessed immediately prior to enrollment:

   1. Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, accidental arterial stick with hematoma, "back wall stick", etc.) in any of the study veins;
   2. A procedural sheath \< 6 Fr or \> 12 Fr in inner diameter is present at time of closure;
   3. Venous access site location is noted to be "high", above the inguinal ligament (cephalad to lower half of the femoral head or the inferior epigastric vein origin from the external iliac vein);
   4. Intra-procedural bleeding around sheath, or forming hematoma at the time of closure;
   5. Length of the tissue tract, the distance between the anterior venous wall and skin, is estimated to be less than 2.5 cm.

Discharge Evaluation Criteria

1. Physician or designee must perform discharge evaluation on the same day as the procedure.
2. Subject has successfully ambulated without bleeding from access site.
3. Subject has been able to void.
4. No clinically significant ECG findings.
5. Subject is accompanied by a responsible person who will be near them for the next 24 hours. Subjects must meet all Discharge Criteria in order to be eligible for same day discharge at physician discretion.

Group 3 All A-Fib Pre-Operative Inclusion Criteria All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:

1. ≥18 years of age;
2. Capable and willing to give informed consent;
3. Acceptable candidate for an elective, atrial fibrillation ablation procedure;
4. Acceptable candidate planned for same day discharge;
5. Able and willing to complete two follow-up contacts at 2-4 days and 15 (± 5) days post-procedure.

Pre-Operative Exclusion Criteria Subjects will be excluded from participating in this study if they meet any of the following criteria prior to initiation of the index procedure:

1. In the index limb(s): Active systemic infection, or cutaneous infection;
2. Known history of bleeding diathesis, coagulopathy, hypercoagulability, or current platelet count \< 100,000 cells/mm3;
3. Currently involved in any clinical trial that may interfere with the outcomes of this study in the opinion of investigator;
4. Femoral catheterization procedure in any study limb in the previous 30 days;
5. Any planned procedure involving femoral arterial or venous access in either limb within the next 30 days;
6. History of deep vein thrombosis, pulmonary embolism or thrombophlebitis in the last 12 months;
7. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or who are lactating;
8. Unable to routinely walk at least 20 feet without assistance;
9. Known allergy/adverse reaction to bovine derivatives;
10. Planned procedures or concomitant condition(s) that may extend ambulation attempts beyond routine ambulation and/or hospital discharge time (e.g., staged procedure, serious co-morbidity, uncontrolled obstructive sleep apnea, congestive heart failure, extreme morbid obesity), in the opinion of the Investigator.

Intra-Operative Inclusion Criteria

All criteria apply:

1. In the Investigator's opinion, the subject is a candidate for Same Day Discharge per protocol (no procedure related events/complications e.g., no new pericardial effusion, post-procedure diuresis not needed, etc.).
2. Case completed in time for subject to be reasonably recovered and discharged according to protocol.
3. 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.

Final subject enrollment will be determined at the end the procedure, prior to closure, based on general intra-op exclusion criteria, as well as additional intraoperative criteria. Enrollment is thus determined intra-operatively, at the end of the case and just prior to closure.

Intra-Operative Exclusion Criteria Subjects will be excluded from participating in this study if any of the following exclusion criteria occur during the index procedure:

1. Any attempt at femoral arterial access during the procedure;
2. In the index limb(s): infection or inflammation in the vicinity of the groin
3. Administration of low molecular weight heparin (LMWH) within 8 hours before or after the procedure;
4. All venous access sites must are subject to the following exclusion criteria, assessed immediately prior to enrollment:

   1. Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, accidental arterial stick with hematoma, "back wall stick", etc.) in any of the study veins;
   2. A procedural sheath \< 6 Fr or \> 12 Fr in inner diameter is present at time of closure;
   3. Venous access site location is noted to be "high", above the inguinal ligament (cephalad to lower half of the femoral head or the inferior epigastric vein origin from the external iliac vein);
   4. Intra-procedural bleeding around sheath, or forming hematoma at the time of closure;
   5. Length of the tissue tract, the distance between the anterior venous wall and skin, is estimated to be less than 2.5 cm.

Discharge Evaluation Criteria

1. Physician or designee must perform discharge evaluation on the same day as the procedure.
2. Subject has successfully ambulated without bleeding from access site.
3. Subject has been able to void.
4. No clinically significant ECG findings.
5. Subject is accompanied by a responsible person who will be near them for the next 24 hours. Subjects must meet all Discharge Criteria in order to be eligible for same day discharge at physician discretion.

Primary outcomes:
measure: VASCADE MVP VVCS Procedure Success
timeFrame: 1 day
measure: Major Complication Rate
timeFrame: 15 Days +/- 5 Days
Secondary outcomes:
measure: Same Day Procedure Success
timeFrame: 1 day
measure: Sustained VASCADE MVP VVCS Procedure Success
timeFrame: 15 Days +/- 5 Days
measure: Device Success
timeFrame: intra-procedural
measure: Minor Complication Rate
timeFrame: 15 Days +/- 5 Days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: San Luis Obispo
country: United States
facility: Coastal Cardiology
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates, The Medical Center of Aurora
state: Colorado
city: Washington
country: United States
facility: MedStar Washington
state: District of Columbia
city: Atlanta
country: United States
facility: Emory St. Joseph's Hospital
state: Georgia
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: Raleigh
country: United States
facility: Wake Med Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Institute
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Fort Worth
country: United States
facility: Medical City Fort Worth
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
city: Richmond
country: United States
facility: Chippenham Hospital
state: Virginia
Study officials:
References: