Atrial Fibrillation
Conditions
Brief summary
This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.
Detailed description
The study will provide information on real-world usage of the Boston Scientific Cardiac Cryoablation System when used to perform pulmonary vein isolation (PVI) for the ablation treatment of atrial fibrillation (AF), according to the current and future guidelines and product indications for use. This may include but not limited to: repeated ablations to treat AF, concomitant or delayed adjunctive ablation strategies with other products and use of different diagnostic products to validate the results such as 3D mapping systems.
Interventions
cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use; 2. Subjects who are willing and capable of providing informed consent; 3. Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center; 4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
Exclusion criteria
1. Any known contraindication to an AF ablation or anticoagulation, including those listed in the instructions for use; 2. Subjects with indication for treatment of AF that is not according to current and future Guidelines and system indications for use; 3. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause; 4. Known or pre-existing severe Pulmonary Vein Stenosis; 5. Evidence of myxoma, LA thrombus or intracardiac mural thrombus; 6. Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA, stent procedure) within 90 days prior to enrollment; 7. Implantable cardiac device procedures (e.g. PM, ICD, CRT) within 30 days prior to enrollment; 8. Implanted Left Atrial Appendage Closure device prior to the index procedure; 9. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder; 10. Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings); 11. Presence of any pulmonary vein stents; 12. Active systemic infection; 13. Vena cava embolic protection filter devices and/ or known femoral thrombus; 14. Any previous history of cryoglobulinemia; 15. History of blood clotting or bleeding disease; 16. Any prior history of documented cerebral infarct, TIA or systemic embolism (excluding a post-operative deep vein thrombosis (DVT)) ≤ 180 days prior to enrollment; 17. Subjects who are hemodynamically unstable; 18. The subject is unable or not willing to complete follow-up visits and examination for the duration of the study; 19. Life expectancy ≤ 1 year per investigator's opinion; 20. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion); 21. Unrecovered/unresolved Adverse Events from any previous invasive Procedure; 22. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Event Free Rate | 12 months | Freedom from procedure or device related adverse events after intervention, analyzed in all treatment and attempt subjects. The Primary Safety Endpoint is analyzed using data from all TREATMENT and ATTEMPT subjects including those with missing data. Subjects with missing data are censored at the appropriate timepoint in the KM analysis |
| Failure Free Rate | 12 months | includes freedom from failure of intervention or more than one repeated procedures within 90 days post index procedure, or documented atrial fibrillation, new onset atrial flutter or atrial tachycardia between 91 days and 365 days post procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Documentation and Rate of Acute Procedural Success | Index Procedure | Electrical isolation of a pulmonary vein (PV) is demonstrated at minimum by entrance block using the Cryo Mapping Catheter. The Secondary Effectiveness Endpoint is analyzed using data from all TREATMENT subjects. |
Countries
Belgium, Croatia, France, Germany, Italy, Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Patients Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use
Boston Scientific Cardiac Cryoablation System: cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins | 398 |
| Total | 398 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Attempt | 2 |
| Overall Study | Consent Ineligible - Does not meet eligibility criteria | 1 |
| Overall Study | Intent | 7 |
| Overall Study | Treatment - Death | 1 |
| Overall Study | Treatment - End of study due to logistical reasons | 2 |
| Overall Study | Treatment - End of study due to refusing testing COVID | 1 |
| Overall Study | Treatment - Lost to Follow-up | 11 |
| Overall Study | Treatment - withdrawal by subject | 14 |
| Overall Study | Treatment - Withdrawn due to unknown reason | 2 |
Baseline characteristics
| Characteristic | Enrolled Patients |
|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 11 |
| Race/Ethnicity, Customized Race Asian | 1 Participants |
| Race/Ethnicity, Customized Race Black | 1 Participants |
| Race/Ethnicity, Customized Race Not Disclosed | 140 Participants |
| Race/Ethnicity, Customized Race White | 256 Participants |
| Region of Enrollment Belgium | 30 participants |
| Region of Enrollment Croatia | 8 participants |
| Region of Enrollment France | 109 participants |
| Region of Enrollment Germany | 105 participants |
| Region of Enrollment Italy | 45 participants |
| Region of Enrollment Netherlands | 47 participants |
| Region of Enrollment United Kingdom | 54 participants |
| Sex: Female, Male Female | 147 Participants |
| Sex: Female, Male Male | 251 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 399 |
| other Total, other adverse events | 47 / 399 |
| serious Total, serious adverse events | 71 / 399 |
Outcome results
Primary
Failure Free Rate
includes freedom from failure of intervention or more than one repeated procedures within 90 days post index procedure, or documented atrial fibrillation, new onset atrial flutter or atrial tachycardia between 91 days and 365 days post procedure
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Safety Endpoint | Failure Free Rate | 223 Participants |
Primary
Safety Event Free Rate
Freedom from procedure or device related adverse events after intervention, analyzed in all treatment and attempt subjects. The Primary Safety Endpoint is analyzed using data from all TREATMENT and ATTEMPT subjects including those with missing data. Subjects with missing data are censored at the appropriate timepoint in the KM analysis
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Safety Endpoint | Safety Event Free Rate | 373 Participants |
Secondary
Documentation and Rate of Acute Procedural Success
Electrical isolation of a pulmonary vein (PV) is demonstrated at minimum by entrance block using the Cryo Mapping Catheter. The Secondary Effectiveness Endpoint is analyzed using data from all TREATMENT subjects.
Time frame: Index Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Safety Endpoint | Documentation and Rate of Acute Procedural Success | 359 Participants |