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PVI Alone Versus Additional Low-voltage Substrate Modification During SR Guiding by Contact-force Catheter in Older Patients With Paroxysmal AF (Stable III)

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ClinicalTrials.gov Identifier: NCT03462628
Recruitment Status : Unknown
Verified March 2018 by Minglong Chen, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Not yet recruiting
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborators:
The Affiliated Hospital of Xuzhou Medical University
First Affiliated Hospital of Wannan Medical College
Second Affiliated Hospital of Nantong University
Zhongda Hospital
The Third Affiliated Hospital of Soochow University
The Second Hospital of Hebei Medical University
The First Affiliated Hospital of Soochow University
Xuzhou Central Hospital, the Affiliated Xuzhou Hospital of Medical College of Southeast University
Air Force Military Medical University, China
Information provided by (Responsible Party):
Minglong Chen, The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in older patients with paroxysmal AF: Pulmonary vein isolation alone versus additional low-voltage substrate modification during sinus rhythm

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Procedure: PVI Not Applicable

Detailed Description:

BACKGROUND: Atrial fibrillation (AF) is the most common cardiac rhythm disorder. Catheter ablation to the pulmonary veins isolation (PVI) electrically from the left atrium (LA) has been shown to be an effective treatment for paroxysmal AF (PAF). The consensus is that PVI alone is the main strategy for PAF ablation. Based on the results from our pilot study and STABLE-SR trial, that low-voltage modification beyond CPVI is very promising for persistent AF ablation. Whether the low voltage area modification combined with PVI improves outcomes is unclear in older patients with PAF.

AIM OF THE STUDY: The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in older patients with PAF: PVI alone versus additional low-voltage substrate modification during sinus rhythm. The primary endpoint is freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12 months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each atrial tachyarrhythmia episode lasts > 30 seconds monitored by ECG, 24-Holter or 7 days-Holter was defined as recurrence. The secondary endpoint are incidence of periprocedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death; procedure time; fluoroscopy time (including the total fluoroscopy time, during CPVI and after CPVI); the occurrence of the conversion from AF to AT, and its relationship with long-term outcome; the scar distribution and the relationship of success rate in older PAF patients.

STUDY DESIGN: This is a randomized, prospective, parallel, single-blind multicenter design. The expected freedom from atrial fibrillation in older patients after one ablation procedure was 75% for PVI. Previous study did not include a group assigned to isolation plus additional low-voltage substrate modification during sinus rhythm, so freedom form AF for this procedure was estimated from the literature at 85%. A log-rank test was used for sample-size calculation. To test whether the isolation plus low-voltage substrate modification was superior to isolation only. Then the 369 patients were needed, with a randomization ratio of 1:1, for the study to have a power of 90% at a two-sided alpha level of 0.05. Assuming a dropout rate of 15%, we need 434 patients. Patients are randomized in a 1:1 fashion into one of the investigation arms: CPVI plus low-voltage substrate modification in the left atrium during SR and CPVI alone. Follow-up for these patients includes visits at 3 m, 6 m, 9 m, 12 m.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 434 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Participant)
Masking Description: Single (Participant)
Primary Purpose: Treatment
Official Title: Pulmonary Vein Isolation Alone Versus Additional Low-voltage Substrate Modification During Sinus Rhythm Guiding by Contact-force Catheter in Older Patients With Paroxysmal Atrial Fibrillation: a Prospective, Multicenter, Randomized Clinical Trial
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Group
PVI with additional low-voltage substrate modification
Procedure: PVI
CPVI plus low-voltage substrate modification in the left atrium during SR and CPVI alone
Other Name: PVI plus additional low-voltage substrate modification

Active Comparator: Control Group
PVI
Procedure: PVI
CPVI plus low-voltage substrate modification in the left atrium during SR and CPVI alone
Other Name: PVI plus additional low-voltage substrate modification




Primary Outcome Measures :
  1. Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) [ Time Frame: at least 12 months follow up] ]
    Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each episode lasts > 30 seconds.


Secondary Outcome Measures :
  1. Incidence of peri-procedural complications [ Time Frame: 1 week after patient enrollment ]
    stroke, cardiac perforation, and death

  2. complications during the follow-up [ Time Frame: 1month to 12 months ]
    PV stenosis, esophageal injury

  3. Procedure time [ Time Frame: 1 week after patient enrollment ]
    time that the patient spend in the procedure room

  4. Fluoroscopy time [ Time Frame: 1 week after patient enrollment ]
    the total fluoroscopy time, during PVI alone or PVI plus low-voltage substrate modification



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients age is 18-80 years;
  • Patients with paroxysmal AF;
  • Patients can sign the written informed consent for the study;
  • Patients can endure the required follow-up.

Exclusion Criteria:

  • Patients with previous radiofrequency ablation;
  • Patients with PLT count less than 80×109/L, or with contraindications to systemic anticoagulation with heparin or Coumadin or a direct thrombin inhibitor;
  • Patients with left atrial size ≥ 55 mm (2D echocardiography, parasternal long-axis view);
  • Patients with thromboemboli in LA (TEE or MSCT);
  • Patients with severe structural cardiac disease (medium or severe mitral regurgitation, DCM, HCM, or other severe valvular heart diseases);
  • Patients with abnormal thyroid function;
  • Patients with severe liver or renal dysfunction (AST or ALT > 3-fold of upper limit value; the SCr > 3.5 mg/dl or Ccr < 30 ml/min);
  • Previous surgery history in last 3 months;
  • Patients with life expectancy < 12 months

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): NCT03462628


Contacts
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Contact: Hongwu Chen, MD 0086-25-68303115 chw2003_0_79@163.com

Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
The Affiliated Hospital of Xuzhou Medical University
First Affiliated Hospital of Wannan Medical College
Second Affiliated Hospital of Nantong University
Zhongda Hospital
The Third Affiliated Hospital of Soochow University
The Second Hospital of Hebei Medical University
The First Affiliated Hospital of Soochow University
Xuzhou Central Hospital, the Affiliated Xuzhou Hospital of Medical College of Southeast University
Air Force Military Medical University, China
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Responsible Party: Minglong Chen, Deputy Director of the Department of Cardiology, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03462628    
Other Study ID Numbers: 2015-SR-085
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

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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 Minglong Chen, The First Affiliated Hospital with Nanjing Medical University:
substrate modification
pulmonary vein isolation
ablation
Paroxysmal Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes