Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, randomized (1:1), pilot study enrolling 200 patients with symptomatic atrial fibrillation or atrial tachycardia (AF/AT) recurrence requiring repeat ablation following a single prior PVI procedure for AF.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CF-guided RFC: Re-PVI and substrate modification of low voltage areas | Experimental | Patient get intervention via Contact force guided radiofrequency ablation |
|
| Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage ath | Experimental | Patient will get Intervenstion via Large footprint PFA/RFC catheter (Sphere 9) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areas | Procedure | Re-PVI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | Complete re-pulmonary vein isolation (re-PVI), Bidirectional conduction block across linear lesions, Complete substrate elimination (defined as: voltage abatement and/or loss of capture). | Within the study duration of 1 Year |
Not provided
Not provided
Inclusion Criteria:
Age 18-85 years Willing and able to comply with the study protocol Willing and able to operate a device for rhythm monitoring
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julian Chun, Professor | Contact | +49 69 945028 | 0 | j.chun@ccb.de |
| Boris Schmidt, Professor | Contact | +49 69 945028 | 0 | b.schmidt@ccb.de |
| Name | Affiliation | Role |
|---|---|---|
| Julian Chun, Professor | MVZ CCB Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardioangiologisches Centrum Bethanien, Frankfurt am Main, 60431 | Recruiting | Frankfurt am Main | Hesse | 60431 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CF-guided RFC: Re-PVI and substrate modification of low voltage areas | Procedure | Re-PVI |
|