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Low Voltage-Directed Catheter Ablation for Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03355456
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Ohad Ziv, MetroHealth Medical Center

Brief Summary:

A three-pronged approach to evaluate long term success of non-paroxysmal ablation when using a:

  1. specified low voltage-directed with pulmonary vein isolation (LD+PVI) approach compared to ,
  2. empiric posterior wall isolation with pulmonary vein isolation (PW+PVI) approach compared to
  3. an approach of pulmonary vein isolation (PVI) alone.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation - Symptomatic Procedure: Radiofrequency ablation Not Applicable

Detailed Description:

Patients that meet both inclusion and exclusion criteria will be randomized by the study clinical center. Patients will be randomized 1:1:1 into one of the following arms:

  • PVI with additional total left atrial low voltage-directed ablation.
  • PVI with posterior wall low voltage quantification and isolation
  • PVI alone without low voltage quantification.

All patients will receive the best conventional medical therapy and anticoagulation use based upon HRS consensus recommendations taking into account their baseline risk factors for stroke. The need for interruption of anticoagulation and antiarrhythmic drug therapy for the procedure will be determined by the operator and their center guidelines.

The trial requires continuous monitoring for atrial arrhythmias. Investigators will recommend the use of implantable loop recorders (ILR) but continuous 30 day monitoring with auto-trigger function may be substituted at the 6, 9 and 12 month time points. The ILR device will be implanted under sterile conditions at the manufacture's recommended site on the precordium for arrhythmia monitoring. Implantation will occur between 1 month prior and 3 months post ablation since there will be a 3 month post ablation blanking period. If a dual chamber device is already present, implantation will not be required.

One year follow-up is planned. Post procedure care is per standard of care with follow-up at 1 month, 3 months, 6 months, 9 months and 12 months. ECG at every follow-up is performed. Download of arrhythmia data will occur at each of these visits as well. Investigators will use the typical post ablation blanking period for recurrence of atrial fibrillation of 3 months. Antiarrhythmic medications can be used during the typical "blanking period" of 3 months post procedure. But per protocol are stopped at 3 months post procedure (2 months post procedure in case of amiodarone).

Investigators will compare time freedom from first arrhythmia event, defined as a sustained episode of atrial fibrillation or atrial tachycardia. Secondary endpoints will be compared as well (see secondary end point defined). Re-initiation of an antiarrhythmic drug after 3 months will be considered a failure of primary endpoint of arrhythmia free survival. However, Anti-arrhythmic medication use after the blanking period for ventricular arrhythmias will not be included as an event. Anticoagulation is continued and monitored based on previous guidelines with use stratified by baseline stroke risk. A recording (CD) of the mapping during the procedure is to be obtained and retained for possible future analysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized comparison of three ablation techniques:

  1. Pulmonary vein isolation (PVI) alone to
  2. PVI plus total left atrial low voltage-directed ablation to
  3. PVI plus non-voltage-directed posterior wall ablation
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Patients will be blinded to whichever ablation arm they are randomized to. Events adjudicator will be blinded to randomization arm.
Primary Purpose: Treatment
Official Title: Prospective, Multi-center, Randomized, Evaluation Comparing the Protocol Specified Ablation Approach to the Current Standardized Ablation Approach in the Treatment of Non-paroxysmal Atrial Fibrillation.
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pulmonary vein isolation (PVI) alone
Radiofrequency ablation procedure to isolate pulmonary veins without other intervention performed..
Procedure: Radiofrequency ablation
Ablation procedure to eliminate atrial fibrillation
Other Name: Pulmonary vein isolation, posterior wall ablation

Active Comparator: PVI+Total LT Atrial low voltage ablation
PVI radiofrequency ablation along with ablation of areas of "low voltage" identified.
Procedure: Radiofrequency ablation
Ablation procedure to eliminate atrial fibrillation
Other Name: Pulmonary vein isolation, posterior wall ablation

Active Comparator: PVI + Posterior wall ablation
PVI radiofrequency ablation along with ablation of the posterior wall.
Procedure: Radiofrequency ablation
Ablation procedure to eliminate atrial fibrillation
Other Name: Pulmonary vein isolation, posterior wall ablation




Primary Outcome Measures :
  1. Freedom from first arrhythmia recurrence defined as sustained symptomatic or asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia. [ Time Frame: Any event between the 3 month blanking period and 1 year post-ablation. ]
    The primary endpoint is freedom from sustained symptomatic or asymptomatic atrial arrhythmia (atrial fibrillation, atrial flutter or atrial tachycardia - AT/AF) i.e.; NO change from sinus rhythm to atrial arrhythmia between 3 -12 months after ablation. Recurrence of AF/AT excludes the 3 month blanking period. Sustained AF/AT is defined as >30 seconds as recorded on a monitoring device.


Secondary Outcome Measures :
  1. Reduced arrhythmia burden (frequency that arrhythmia occurs). [ Time Frame: Between the 3 month blocking period and 1 year post-ablation. ]
    Comparison of arrhythmia burden as determined by the composite percent of atrial arrhythmia during the total time recorded on implantable monitoring devices.

  2. Freedom from sustained AF/AT [ Time Frame: Any event between the 3 month blocking period and 1 year post-ablation. ]
    Freedom from sustained AF/AT is defined as >30 seconds as recorded on a monitoring device.

  3. Freedom from any symptomatic AF/AT [ Time Frame: Any event between the 3 month blocking period and 1 year post-ablation. ]
    Freedom from any symptomatic AF/AT is defined regardless of duration as recorded on a monitoring device.

  4. Reduced need for antiarrhythmic drugs (AAD) [ Time Frame: Any event between the 3 month blocking period and 1 year post-ablation. ]
    Comparison of the use of AAD therapy to control atrial arrhythmias after a successful ablation.


Other Outcome Measures:
  1. Incidence of procedure related adverse events. [ Time Frame: Any event up to 1 year post-ablation. ]

    The safety endpoint is the incident of procedure related adverse events comparing the 3 arms of the study. Adverse events being tracked are:

    1. All-cause mortality
    2. Atrio-esophageal fistula (through 12 mo)
    3. Atrial perforation
    4. Cardiac Tamponade
    5. Pericardial Effusion
    6. Pericarditis
    7. Heart Block
    8. Myocardial infarction
    9. Cerebrovascular Accident (CVA)
    10. Transient ischemic Attack
    11. Thromboembolism
    12. PV stenosis >70% from baseline (through 12 mo)
    13. Diaphragm Paralysis
    14. Pulmonary Edema
    15. Pneumothorax
    16. Limb Paralysis
    17. Procedural blood loss ≥ 1000cc
    18. Respiratory failure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all of the following criteria:

  1. Non-Paroxysmal Atrial Fibrillation.
  2. Failed or intolerable to at least 1 one antiarrhythmic drug (AAD).
  3. 18-85 year of age at time of consent.
  4. Able and willing to comply with all protocol visit requirements.
  5. Signed Patient Informed Consent (ICF).

Exclusion Criteria:

Subjects will be excluded if any of the follow criteria are present:

  1. History of prior left-sided catheter or surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE.

    • Prior ablation for typical atrial flutter or left-sided ablation for WPW, AV node reentry tachycardia or focal ectopic atrial tachycardia may be included.
  2. Uncontrolled heart Failure or NYHA Class IIIb or IV heart failure.
  3. Ejection Fraction < 0.20.
  4. Active ventricular tachycardia requiring treatment with catheter ablation or anti-arrhythmic drug within the last 6 months.
  5. Left atrial size > 60 mm diameter on echocardiogram.
  6. "Long standing" persistent AF defined as > or = 1 year of continuous atrial fibrillation at the time of enrollment.
  7. Severe pulmonary hypertension (PAP > 70 mmHg)
  8. AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause.
  9. Poor candidate for general anesthesia.
  10. Anticipated survival < 1 year.
  11. MI or CABG within 3 months.
  12. Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure.
  13. Any documented thromboembolic event within 6 months of the ablation procedure.
  14. Contraindication to anticoagulation.
  15. Inability to have implantable monitoring device for atrial fibrillation burden with no pre-existing cardiac device that can monitor atrial arrhythmias OR inability to wear external Holter Monitor continuously for 4 weeks.
  16. Significant congenital anomaly or medical condition that may affect the integrity of study data.
  17. Women who are pregnant - pregnancy test required if pre-menopausal or non-sterile.
  18. Active enrollment in another investigational study involving a drug or device.
  19. Inability to undergo complete voltage mapping in normal sinus rhythm - see intraprocedural protocol.

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): NCT03355456


Contacts
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Contact: Peter Leo BS, RN 216-778-2714 pleo@metrohealth.org

Locations
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United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Peter Leo BS, RN    216-778-2714    pleo@metrohealth.org   
Sponsors and Collaborators
Ohad Ziv
Biosense Webster, Inc.
Investigators
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Principal Investigator: Ohad Ziv, MD The MetroHealth System
  Study Documents (Full-Text)

Documents provided by Ohad Ziv, MetroHealth Medical Center:
Publications:
Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. J Interv Card Electrophysiol. 2012 Mar;33(2):171-257. doi: 10.1007/s10840-012-9672-7. Review.

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Responsible Party: Ohad Ziv, Director, Cardiac Electrophysiology, Principal Investigator, Professor of Medicine, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT03355456    
Other Study ID Numbers: IRB17-00025
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Ohad Ziv, MetroHealth Medical Center:
Persistent atrial fibrillation
Medication refractory atrial fibrillation
Pulmonary vein isolation procedure
Low voltage directed ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes