CLOSE Versus High Density Mapping Guided Catheter Ablation of Paroxysmal Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT04466358|
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Vein Isolation||Procedure: Modified CLOSE protocol Procedure: High density mapping guided pulmonary vein isolation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of CLOSE Guided and High Density Mapping Guided Catheter Ablation of Paroxysmal Atrial Fibrillation|
|Estimated Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||September 1, 2024|
|Estimated Study Completion Date :||September 1, 2024|
Experimental: Modified CLOSE protocol
Width antral circumferential pulmonary vein isolation guided according to CLOSE protocol, confirmed with multipolar circular mapping catheter.
Procedure: Modified CLOSE protocol
Modified CLOSE protocol guided isolation of pulmonary veins.
Active Comparator: High density mapping guided pulmonary vein isolation
Width antral circumferential pulmonary vein isolation guided according to CLOSE protocol and confirmed with high density mapping of each pulmonary vein antrum, with additional ablation lesions at sites of gap or dormant conduction.
Procedure: High density mapping guided pulmonary vein isolation
Modified CLOSE protocol guided isolation of pulmonary veins with additional ablations at sites of gaps or dormant conduction as evidenced by high density mapping of pulmonary vein antra.
- Recurrence of atrial fibrillation [ Time Frame: 3-12 months ]Atrial fibrillation recorded with 12-lead ECG, event monitor or a 30 seconds episode recorded with Holter ECG.
- Durability of pulmonary vein isolation [ Time Frame: 12 months ]Presence of gaps in the circumferential ablation line (reconduction of pulmonary veins) as evidenced at predefined remapping procedure.
- Characteristics of gaps in ablation lines [ Time Frame: 0-12 months ]Characteristics of electrograms and ablation lesions in the areas where gaps in the ablation line will be discovered acutely during high density mapping at index procedure. Also, characteristics of electrograms and ablation lesions in the areas where gaps will be discovered at a remote re-mapping procedure at 12 months after the index procedure
- Adverse events [ Time Frame: 0-1 month ]
During and after the procedure and at clinical follow-ups, any serious adverse event will be recorded. Significant adverse events will be defined as all events that endanger the participant's health or prolong hospitalization, or require intervention:
- Death in hospital
- Pericardial effusion resulting in tamponade
- Cerebral insult
- Phrenic nerve injury
- Esophageal perforation
- Cardiac arrest
- Complete atrioventricular block
- Vascular intervention and / or surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466358
|Contact: Matevz Jan, MDemail@example.com|
|Contact: Nina Kajdic, MDfirstname.lastname@example.org|
|Study Director:||Jernej Stublar, MSE||University Medical Centre Ljubljana|
|Study Chair:||Bor Antolic, MD, PhD||University Medical Centre Ljubljana|