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Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation (PROMPT-AF)

Primary Purpose

Persistent Atrial Fibrillation, Catheter Ablation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
upgraded '2C3L'
pulmonary vein antral isolation
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Pulmonary vein antral isolation, Upgraded '2C3L', Arrhythmia-free survival

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

Patients must meet all the following criteria to be included in the study:

  1. age between 18 and 80,
  2. patients undergoing a first-time ablation procedure for non-valvular AF,
  3. patients with defined as a sustained episode more than 3 months but less than 3 years,
  4. PeAF documented by ECG, Holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within 90 days6 months of the ablation procedure,
  5. patients experienced symptoms caused by AF and these symptoms include but are not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath,
  6. AF refractory to at least one AAD,
  7. willingness, ability and commitment to provide informed consent and participate in follow-up evaluations.

Exclusion criteria Patients are to be excluded if any of the following criteria is met：

  1. patients with paroxysmal AF,
  2. patients with AF secondary to an obvious reversible cause,
  3. patients with LA diameter ≥ 60 mm in the parasternal long axis view,
  4. left ventricular ejection fraction (LVEF) < 30%,
  5. patients with triple (aspirin, clopidogrel and OAC) or dual (clopidogrel and OAC) antithrombotic therapy which predispose patients to higher risk of periprocedural bleeding. (e.g., Coronary percutaneous transluminal coronary angioplasty (PTCA)/stenting within the previous 90 days),
  6. patients with contraindication to anticoagulation,
  7. patients with contraindication to right or left sided heart catheterization,
  8. pregnancy,
  9. life expectancy less than 1 year (advanced malignant tumor, end stage renal disease, etc.),
  10. patients cannot be removed from antiarrhythmic drugs for reasons other than AF.

Sites / Locations

  • Beijing Anzhen HospitalRecruiting
  • Sun Yat-sen Memorial HospitalRecruiting
  • Taizhou Hospital of Zhejiang ProvinceRecruiting
  • The First Affiliated Hospital of Harbin Medical UniversityRecruiting
  • Fuwai Central China Cardiovascular HospitalRecruiting
  • Wuhan Asia Heart HospitalRecruiting
  • Jiangsu Provincial HospitalRecruiting
  • Shengli Oilfield Central HospitalRecruiting
  • The First Affiliated Hospital of Shandong First Medical UniversityRecruiting
  • Shandong Provincial HospitalRecruiting
  • Shanghai Renji HospitalRecruiting
  • Sir Run Run Shaw HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Upgraded '2C3L'

Pulmonary vein antral isolation (PVI)

Arm Description

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 cavotricuspid isthmus (CTI).

Patients randomized to the PVI arm will undergo right PV antrum ablation, followed by the left PVA ablation. Radiofrequency 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.

Outcomes

Primary Outcome Measures

The recurrence rate of atrial tachycardia arrhythmias
freedom from any documented atrial arrhythmia after a 3-months post-ablation blanking period, including AF, AT, and AFL, for more than 30 seconds in the absence of antiarrhythmic drug (AAD) therapy.

Secondary Outcome Measures

Freedom from AF/AT with or without AADs
Time to the first occurrence of AF, AT in the presence of AAD therapy after one ablation procedure.
Freedom from AF/AT off AADs
Recurrent AT/AFL over 30 seconds after a 3-month post-ablation blanking period in the absence of AAD
Freedom from AF off AADs
Recurrent AF over 30 seconds after a 3-month post-ablation blanking period in the absence of AAD
AF burden
AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period,
Freedom from AF/AT after multiple procedures
freedom from any documented atrial arrhythmia (AF, AT, and AFL) of more than 30 seconds, after repeated ablation1 or 2 ablation procedures, including AF, AT, and AFL, for more than 30 seconds on/off AADs.
Incidence of procedural complications
cardiac tamponade or perforation, phrenic nerve injury, acute coronary occlusion, leading to death, intervention required, or prolonged hospitalization, strokes /thromboembolism related to AF ablation, pulmonary vein stenosis, left atrial oesophageal fistula, and vascular complications requiring intervention (e.g., pseudoaneurysm, arteriovenous fistula).
AFEQT score change between baseline and 12 month
Quality of life assessed by AF effect on quality-of-life (AFEQT) questionaire
EQ5D score change between baseline and 12 month
Quality of life assessed by EuroQol 5-dimension (EQ5D) scale

Full Information

First Posted
July 8, 2020
Last Updated
August 1, 2023
Sponsor
Beijing Anzhen Hospital
Collaborators
Heart Health Research Centre, The George Institute for Global Health, China, The George Institute for Global Health, Australia, Fukuoka University
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1. Study Identification

Unique Protocol Identification Number
NCT04497376
Brief Title
Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation
Acronym
PROMPT-AF
Official Title
Prospective Randomized Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
Collaborators
Heart Health Research Centre, The George Institute for Global Health, China, The George Institute for Global Health, Australia, Fukuoka University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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 remains controversial. The PROMPT-AF study is a prospective, multicenter, randomized trial involving a 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.
Detailed Description
The PROMPT-AF study will include 498 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 cavotricuspid isthmus. The follow-up duration is 12 months. The primary endpoint is the rate of documented atrial tachycardia arrhythmias of >30 seconds, without any antiarrhythmic drugs, in 12 months after the index ablation procedure (excluding a blanking period of 3 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation, Catheter Ablation
Keywords
Pulmonary vein antral isolation, Upgraded '2C3L', Arrhythmia-free survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
498 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Upgraded '2C3L'
Arm Type
Experimental
Arm Description
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 cavotricuspid isthmus (CTI).
Arm Title
Pulmonary vein antral isolation (PVI)
Arm Type
Active Comparator
Arm Description
Patients randomized to the PVI arm will undergo right PV antrum ablation, followed by the left PVA ablation. Radiofrequency 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.
Intervention Type
Procedure
Intervention Name(s)
upgraded '2C3L'
Other Intervention Name(s)
EI-VOM+2C3L
Intervention Description
Patients randomized to the upgraded '2C3L' arm will first undergo EI-VOM, followed by the '2C3L' ablation step. The details include: (1). EI-VOM procedure: An 8.5-French-long sheath or a steerable long sheath is sent to the coronary sinus (CS) via the femoral vein. A JR4.0 catheter is inserted into the CS to identify the ostium of the VOM. Subsequently, a BMW wire supported by an OTW balloon catheter is advanced into the VOM. The balloon is inflated with 6 to 8 atm in the VOM. A selective venogram of the VOM is obtained by slowly injecting 1 mL of contrast medium. Then, ethanol is slowly injected into the VOM and selective venography of the VOM is repeated. (2) . After EI-VOM, radiofrequency ablation was performed to achieve bilateral pulmonary vein isolation and bidirectional block of mitral isthmus line, roof line, and cavotricuspid isthmus line. (3). Any organized AT observed during the procedure will be targeted as well.
Intervention Type
Procedure
Intervention Name(s)
pulmonary vein antral isolation
Other Intervention Name(s)
PVI
Intervention Description
After reconstructing the left atrial geometry, PVI will be performed (the right PV antrum (PVA) will be ablated first, followed by the left PVA. ) 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. The endpoint of the circumferential PVA ablation procedure is to achieve electrical bilateral PV isolation, that is, the PV potentials associated with atrial electrical activity cannot be recorded during sinus rhythm or CS pacing (entrance block). A waiting period of at least 20 min (after the last PV is isolated) will be used during which spontaneous PV reconnection will be related. , and tDemonstration of exit block (he by pacing in the PV cannot be and proving the absence of transmitted conduction to capture the atrium) may be performed but is not mandatory. Any organized AT observed during the procedure will be targeted as well.
Primary Outcome Measure Information:
Title
The recurrence rate of atrial tachycardia arrhythmias
Description
freedom from any documented atrial arrhythmia after a 3-months post-ablation blanking period, including AF, AT, and AFL, for more than 30 seconds in the absence of antiarrhythmic drug (AAD) therapy.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Freedom from AF/AT with or without AADs
Description
Time to the first occurrence of AF, AT in the presence of AAD therapy after one ablation procedure.
Time Frame
1 year
Title
Freedom from AF/AT off AADs
Description
Recurrent AT/AFL over 30 seconds after a 3-month post-ablation blanking period in the absence of AAD
Time Frame
1 year
Title
Freedom from AF off AADs
Description
Recurrent AF over 30 seconds after a 3-month post-ablation blanking period in the absence of AAD
Time Frame
1 year
Title
AF burden
Description
AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period,
Time Frame
1 year
Title
Freedom from AF/AT after multiple procedures
Description
freedom from any documented atrial arrhythmia (AF, AT, and AFL) of more than 30 seconds, after repeated ablation1 or 2 ablation procedures, including AF, AT, and AFL, for more than 30 seconds on/off AADs.
Time Frame
1 year
Title
Incidence of procedural complications
Description
cardiac tamponade or perforation, phrenic nerve injury, acute coronary occlusion, leading to death, intervention required, or prolonged hospitalization, strokes /thromboembolism related to AF ablation, pulmonary vein stenosis, left atrial oesophageal fistula, and vascular complications requiring intervention (e.g., pseudoaneurysm, arteriovenous fistula).
Time Frame
Within 1 month after the procedure
Title
AFEQT score change between baseline and 12 month
Description
Quality of life assessed by AF effect on quality-of-life (AFEQT) questionaire
Time Frame
1 year
Title
EQ5D score change between baseline and 12 month
Description
Quality of life assessed by EuroQol 5-dimension (EQ5D) scale
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Patients must meet all the following criteria to be included in the study: age between 18 and 80, patients undergoing a first-time ablation procedure for non-valvular AF, patients with defined as a sustained episode more than 3 months PeAF documented by ECG, Holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within 90 days6 months of the ablation procedure, patients experienced symptoms caused by AF and these symptoms include but are not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath, AF refractory to at least one AAD, willingness, ability and commitment to provide informed consent and participate in follow-up evaluations. Exclusion criteria Patients are to be excluded if any of the following criteria is met： patients with paroxysmal AF, patients with AF secondary to an obvious reversible cause, patients with left atrial diameter ≥ 60 mm in the parasternal long axis view, left ventricular ejection fraction (LVEF) < 30%, patients with triple (aspirin, clopidogrel and OAC) or dual (clopidogrel and OAC) antithrombotic therapy which predispose patients to higher risk of periprocedural bleeding. (e.g., Coronary percutaneous transluminal coronary angioplasty (PTCA)/stenting within the previous 90 days), patients with contraindication to anticoagulation, patients with contraindication to right or left sided heart catheterization, pregnancy, life expectancy less than 1 year (advanced malignant tumor, end stage renal disease, etc.), patients cannot be removed from antiarrhythmic drugs for reasons other than AF.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Du Xin, Doctor
Phone
86-10-64420102
Email
duxinheart@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoxia Liu, Doctor
Email
dr_lxx@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caihua Sang, MD
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Changsheng Ma, MD
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianzeng Dong, MD
Organizational Affiliation
Beijing Anzhen Hospital; The First Affiliated Hospital of Zhengzhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chenyang Jiang, MD
Organizational Affiliation
Sir Run Run Shaw Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caihua Sang, MD
Phone
+861084005365
Email
sch9613070@sina.com
Facility Name
Sun Yat-sen Memorial Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510235
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuanglun Xie
Email
xieshuanglun@sina.com
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Hangzhou
ZIP/Postal Code
318050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Ge
Email
gewl@enzemed.com
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaojun Wang
Email
hyd2013@qq.com
Facility Name
Fuwai Central China Cardiovascular Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
451464
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ke Chen
Email
chenke1985@126.com
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinlin Zhang
Email
zjl1974@yeah.com
Facility Name
Jiangsu Provincial Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiangang Zou
Email
jgzou@njmu.edu.cn
Facility Name
Shengli Oilfield Central Hospital
City
Dongying
State/Province
Shandong
ZIP/Postal Code
257034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangfei Liu
Email
zhaoyang20023903@126.com
Facility Name
The First Affiliated Hospital of Shandong First Medical University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hesheng Hu
Email
hyperhhs@163.com
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shangming Song
Email
13808936009@163.com
Facility Name
Shanghai Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinhua Wang
Email
ttwwxh@126.com
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenyang Jiang
Email
chenyangjiangmail@163.com

12. IPD Sharing Statement

Learn more about this trial

Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation

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