| Eligibility |
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.
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