Low Voltage-Directed Catheter Ablation for Atrial Fibrillation

NCT03355456 | Recruiting

• 1 other identifier: IRB17-00025
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Atrial Fibrillation - Symptomatic

Keywords

Persistent atrial fibrillation; Medication refractory atrial fibrillation; Pulmonary vein isolation procedure; Low voltage directed ablation

Outcome Measures

Primary Outcomes (1)

• Freedom from first arrhythmia recurrence defined as sustained symptomatic or asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia.

  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.

  Any event between the 3 month blanking period and 1 year post-ablation.

Secondary Outcomes (4)

• Reduced arrhythmia burden (frequency that arrhythmia occurs).

  Between the 3 month blocking period and 1 year post-ablation.

• Freedom from sustained AF/AT

  Any event between the 3 month blocking period and 1 year post-ablation.

• Freedom from any symptomatic AF/AT

  Any event between the 3 month blocking period and 1 year post-ablation.

• Reduced need for antiarrhythmic drugs (AAD)

  Any event between the 3 month blocking period and 1 year post-ablation.

Other Outcomes (2)

• Incidence of procedure related adverse events.

  Any event up to 1 year post-ablation.

• Tertiary endpoints

  Any event up to 1 year post-ablation.

Study Arms (2)

Pulmonary vein isolation (PVI) alone

ACTIVE COMPARATOR

Radiofrequency ablation procedure to isolate pulmonary veins without other intervention performed..

Procedure: Radiofrequency ablation

PVI+Total LT Atrial low voltage ablation

ACTIVE COMPARATOR

PVI radiofrequency ablation along with ablation of areas of "low voltage" identified.

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablation PROCEDURE

Ablation procedure to eliminate atrial fibrillation

Also known as: Pulmonary vein isolation, low-voltage ablation

PVI+Total LT Atrial low voltage ablation; Pulmonary vein isolation (PVI) alone

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria:
• Non-Paroxysmal Atrial Fibrillation.
• Failed or intolerable to at least 1 one antiarrhythmic drug (AAD).
• year of age at time of consent.
• Scheduled to undergo a clinically indicated AF ablation procedure.
• Able and willing to comply with all protocol visit requirements.
• Signed Patient Informed Consent (ICF).
• Presence of low voltage in the left atrium on 3-D map during index catheter ablation procedure

You may not qualify if:

• Subjects will be excluded if any of the follow criteria are present:
• 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.
• Uncontrolled heart Failure or NYHA Class IIIb or IV heart failure.
• Ejection Fraction \< 0.20.
• Active ventricular tachycardia requiring treatment with catheter ablation or anti-arrhythmic drug within the last 6 months.
• Left atrial size \> 60 mm diameter on echocardiogram.
• "Long standing" persistent AF defined as \> or = 1 year of continuous atrial fibrillation at the time of enrollment.
• Severe pulmonary hypertension (PAP \> 70 mmHg)
• Unstable valvular disease.
• AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause.
• Poor candidate for general anesthesia.
• Anticipated survival \< 1 year.
• MI or CABG within 3 months.
• Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure.

Sponsors & Collaborators

• Ohad Ziv: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

RECRUITING

Related Publications (6)

• January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.

  PMID: 24685669 BACKGROUND

• 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.

  PMID: 22382715 BACKGROUND

• Themistoclakis S, Raviele A, China P, Pappone C, De Ponti R, Revishvili A, Aliot E, Kuck KH, Hoff PI, Shah D, Almendral J, Manolis AS, Chierchia GB, Oto A, Vatasescu RG, Sinkovec M, Cappato R; Atrial Fibrillation Survey Investigators. Prospective European survey on atrial fibrillation ablation: clinical characteristics of patients and ablation strategies used in different countries. J Cardiovasc Electrophysiol. 2014 Oct;25(10):1074-81. doi: 10.1111/jce.12462. Epub 2014 Jul 8.

  PMID: 24891043 BACKGROUND

• Lin YJ, Chang SL, Lo LW, Hu YF, Chong E, Chao TF, Chung FP, Liao J, Li CH, Tsao HM, Kao T, Chen YY, Huang JL, Chen SA. A prospective and randomized comparison of limited versus extensive atrial substrate modification after circumferential pulmonary vein isolation in nonparoxysmal atrial fibrillation. J Cardiovasc Electrophysiol. 2014 Aug;25(8):803-812. doi: 10.1111/jce.12407. Epub 2014 Apr 9.

  PMID: 24628987 BACKGROUND

• Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054.

  PMID: 15172410 BACKGROUND

• Hwang C, Chen PS. Ligament of Marshall: why it is important for atrial fibrillation ablation. Heart Rhythm. 2009 Dec;6(12 Suppl):S35-40. doi: 10.1016/j.hrthm.2009.08.034.

  PMID: 19959141 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Ohad Ziv, MD

  MetroHealth System, Ohio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Leo BS, RN

CONTACT

216-778-2714; pleo@metrohealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be blinded to whichever ablation arm they are randomized to. Events adjudicator will be blinded to randomization arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Cardiac Electrophysiology, Principal Investigator, Professor of Medicine

Model Details: Randomized comparison of two ablation techniques: 1. Pulmonary vein isolation (PVI) alone to 2. PVI plus total left atrial low voltage-directed ablation.

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 28, 2017
• Study Start: July 14, 2019
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)