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The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with the PulseSelect PFA System.
This study will include subjects with a diagnosis of recurrent symptomatic Paroxysmal and Persistent AF. Following the index ablation procedure and hospital discharge, all study subjects will be followed at 7 days, 2 months, 6 months, and 12 months and will be exited from the study at the conclusion of the 12-month follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AF ablation | Experimental | AF Ablation using the PulseSelect Pulse Field Ablation (PFA) System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PulseSelect Pulse Field Ablation (PFA) System | Device | Adult subjects with recurrent symptomatic paroxysmal AF or persistent AF will be enrolled and undergo ablation with the PulseSelectâ„¢ PFA system. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of Participants with at Least One Primary Safety Event | Primary Safety events are: Within 7 days of ablation procedure:
Within 3 months post-ablation: - Atrioesophageal fistula/Esophageal perforation (procedure and PulseSelect PFA Loop Catheter related) Within 6 months post-ablation: - Pulmonary vein stenosis (≥70% diameter reduction) | Up to 6 months post procedure |
| Effectiveness: Number of Participants with Treatment Success | Treatment success is defined as freedom from documented recurrence of AF, AT, or AFL based on electrocardiographic data up to the 12-month follow-up and excluding a 90-day blanking period. Treatment failure is defined as any of the following components:
| Up to 12 months post procedure |
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Inclusion Criteria:
Adults who are ≥18 and ≤80 years of age on the day of enrollment (or older than 18 if required by local law)
A diagnosis of recurrent symptomatic paroxysmal or persistent AF:
Symptomatic paroxysmal AF: AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following:
Symptomatic persistent AF: Continuous AF sustained beyond 7 days and less than 1 year, documented by the following:
Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rob van der Straaten, PhD | Contact | +31611249276 | rob.vanderstraaten@medtronic.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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