Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation (PROMPT-AF)
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|ClinicalTrials.gov Identifier: NCT04497376|
Recruitment Status : Not yet recruiting
First Posted : August 4, 2020
Last Update Posted : August 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Persistent Atrial Fibrillation Catheter Ablation||Procedure: upgraded '2C3L' Procedure: pulmonary vein antral isolation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Prospective Randomized Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Upgraded '2C3L'
Patients randomized to the upgraded '2C3L' arm will first undergo ethanol infusion in the vein of Marshall (EI-VOM) followed by the '2C3L' ablation step which includes bilateral circumferential PV antral ablation and linear ablations across the left atrial roof, mitral isthmus (MI), and cavo-tricuspid isthmus (CTI).
Procedure: upgraded '2C3L'
EI-VOM: 2 to 4 mL of 95% ethanol will be slowly injected over 1 minute into the distal VOM, After 5 minutes, another injection will be performed for the middle and then proximal part of the VOM. In total, 6 to 12 mL of ethanol will be used as the maximum dose. '2C3L' ablation procedure: The roof and posterior segments will be ablated first when performing left PVI, and RF will not be applied for the anterior part of the left PV unless necessary. MI ablation will commence at about 1 cm from the junction of the VOM and coronary veins near the annulus side and extend along the isthmus to the low-voltage area. Ablation will also be performed in the distal CS, the corresponding epicardial site. Next, CTI ablation will be performed starting from the tricuspid valve annulus and proceeding to the inferior cava veins. The procedural endpoint will be isolation of the bilateral PVA and complete conduction block across the three ablation lines.
Other Name: EI-VOM+2C3L
Active Comparator: Pulmonary vein antral isolation (PVI)
Patients randomized to PVI arm will undergo right PV antrum ablation, followed by the left PVA ablation. Radio frequency should be applied 1 cm proximal to the PV ostia in a wide-area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished.
Procedure: pulmonary vein antral isolation
The right PV antrum (PVA) will be ablated first, followed by the left PVA. RF should be applied 1 cm proximal to the PV ostia in a wide-area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished. If AF or other sustained atrial tachyarrhythmias persist after complete PVI, ablation of the CTI will be left to the operator's judgement. Direct current cardioversion will then be performed to restore sinus rhythm. The endpoint of the circumferential PVA ablation procedure will be achievement of complete entrance and exit block of all PVAs as recorded by the high-density mapping catheter during sinus rhythm or CS pacing and complete linear block if performed.
Other Name: PVI
- Freedom from any documented atrial arrhythmia [ Time Frame: 1 year ]Time to the first occurrence of AF, AT, and atrial flutter of more than 30 seconds in the absence of AAD therapy after one ablation procedure
- Freedom from AF/AT on AADs [ Time Frame: 1 year ]Time to the first occurrence of AF, AT in the presence of AAD therapy after one ablation procedure
- Acute procedural complications [ Time Frame: Through the whole procedure, an average of 5 hours ]Number of Participants with complications occurring during the ablation procedure
- Total mortality rate of acute procedural complications [ Time Frame: Through the whole procedure, an average of 5 hours ]Total mortality rate of complications occurring during the ablation procedure
- Subacute procedural complications [ Time Frame: 1 month post procedure ]Number of Participants with complications occurring during the first month post procedure
- Total procedure time [ Time Frame: Through the whole procedure, an average of 5 hours ]
- Fluoroscopy time [ Time Frame: Through the whole procedure, an average of 5 hours ]
- Total RF ablation time [ Time Frame: Through the whole procedure, an average of 5 hours ]
- Total extent of ablated left atrial tissue [ Time Frame: Through the whole procedure, an average of 5 hours ]
- Cardiovascular hospitalizations [ Time Frame: 1 year ]Number of participants with hospitalizations due to cardiovascular diseases
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): NCT04497376
|Contact: Du Xin, Doctoremail@example.com|
|Contact: Xiaoxia Liu, Doctorfirstname.lastname@example.org|
|Principal Investigator:||Changsheng Ma, Doctor||Beijing Anzhen Hospital|
|Principal Investigator:||Jianzeng Dong Dong, Doctor||Beijing Anzhen Hospital; The First Affiliated Hospital of Zhengzhou University|
|Principal Investigator:||Caihua Sang, Doctor||Beijing Anzhen Hospital|