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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
Sponsor:
Collaborators:
Heart Health Research Centre
The George Institute for Global Health, China
The George Institute for Global Health, Australia
Fukuoka University
Information provided by (Responsible Party):
Chang sheng Ma, Beijing Anzhen Hospital

Brief Summary:
Catheter ablation has emerged as an important treatment option for patients with symptomatic atrial fibrillation (AF). Pulmonary vein antral isolation (PVI) is now considered as the cornerstone technique of AF ablation and has shown promise in treating paroxysmal atrial fibrillation (PAF). However, there is no unique strategy for ablation of persistent AF (PeAF) , whether PVI alone is sufficient to prevent patients from recurrence remain controversial. The PROMPT-AF study is a prospective, multicenter, randomized trial involving blinded assessment of outcomes, which is designed to compare arrhythmia-free survival between PVI and an ablation strategy termed upgraded '2C3L' for ablation of PeAF.

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Catheter Ablation Procedure: upgraded '2C3L' Procedure: pulmonary vein antral isolation Not Applicable

Detailed Description:
The PROMPT-AF study will include 288 patients undergoing their first catheter ablation of PeAF. All patients will be randomized to either the upgraded '2C3L' arm or PVI arm in a 1:1 fashion. The upgraded '2C3L' technique is a fixed ablation approach consisting of EI-VOM, bilateral circumferential PVI and three linear ablation lesion sets across the mitral isthmus, left atrial roof, and cavo-tricuspid isthmus. The follow-up duration is 12 months. The primary endpoint is freedom from any documented atrial tachycardia arrhythmias of > 30 seconds from 3 to 12 months after a single ablation procedure (including a blanking period of 3 months) off antiarrhythmic drugs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Acute procedural complications [ Time Frame: Through the whole procedure, an average of 5 hours ]
    Number of Participants with complications occurring during the ablation procedure

  3. 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

  4. Subacute procedural complications [ Time Frame: 1 month post procedure ]
    Number of Participants with complications occurring during the first month post procedure

  5. Total procedure time [ Time Frame: Through the whole procedure, an average of 5 hours ]
  6. Fluoroscopy time [ Time Frame: Through the whole procedure, an average of 5 hours ]
  7. Total RF ablation time [ Time Frame: Through the whole procedure, an average of 5 hours ]
  8. Total extent of ablated left atrial tissue [ Time Frame: Through the whole procedure, an average of 5 hours ]
  9. Cardiovascular hospitalizations [ Time Frame: 1 year ]
    Number of participants with hospitalizations due to cardiovascular diseases



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age between 18 and 80
  2. patients undergoing a first-time ablation procedure for atrial fibrillation (AF)
  3. persistent symptomatic AF with 2 ECG-documented episodes of AF at least 7 days apart within the last 6 months
  4. symptomatic AF refractory to at least one class I, II, or III antiarrhythmic drugs (AAD)
  5. willingness, ability and commitment to participate in follow-up evaluations

Exclusion Criteria:

  1. coronary artery bypass graft surgery within 1 year of screening
  2. uncontrolled congestive heart failure or ejection fraction <35% as measured by echocardiography
  3. significant valvular disease and/or prosthetic heart valve(s)
  4. myocardial infarction or stroke within 3 months of screening
  5. significant congenital heart disease
  6. left atrial (LA) diameter greater than 60 mm on long axis parasternal view
  7. allergy to contrast media
  8. severe electrolyte abnormalities within 1 month of treatment
  9. contraindication to anticoagulation
  10. pulmonary emboli or stroke within 1 year of screening
  11. LA thrombus as measured by pre-procedure transesophageal echocardiography (TEE) or Computer Tomography (CT)
  12. pregnancy
  13. any contraindication to right or left sided heart catheterization
  14. poor general health
  15. life expectancy less than 1 year
  16. Patients with a sustained episode lasting >3years
  17. Cannot be removed from antiarrhythmic drugs for reasons other than AF
  18. Unwilling or unable to provide informed consent

Information from the National Library of Medicine

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


Contacts
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Contact: Du Xin, Doctor 86-10-64420102 duxinheart@sina.com
Contact: Xiaoxia Liu, Doctor dr_lxx@126.com

Sponsors and Collaborators
Beijing Anzhen Hospital
Heart Health Research Centre
The George Institute for Global Health, China
The George Institute for Global Health, Australia
Fukuoka University
Investigators
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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
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Responsible Party: Chang sheng Ma, Director of Cardiology, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT04497376    
Other Study ID Numbers: 2017YFC0908803
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang sheng Ma, Beijing Anzhen Hospital:
Pulmonary vein antral isolation
Upgraded '2C3L'
Arrhythmia-free survival
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes