Posterior Wall And Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation

NCT04216667 | Terminated DMC

• 1 other identifier: 2019-10714
• Study Type: interventional
• Target: 124
• Locations: 7 countries
• Sites: 16

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of empirical posterior wall isolation (PWI), left atrial appendage electrical isolation (LAAEI) and coronary sinus isolation (CSI) when compared to pulmonary vein isolation (PVI) alone:

• PVI alone,
• PVI + PWI,
• PVI + PWI + LAAEI,
• PVI + PWI + LAAEI + CSI.

Conditions

Atrial Fibrillation

Keywords

Catheter Ablation; Arrhythmia Recurrence; Embolic Stroke; Mortality

Outcome Measures

Primary Outcomes (2)

• Freedom from documented AF/AT/AFL episodes and all-cause mortality after initial procedure

  The primary effectiveness endpoint is defined as the freedom from documented AF/AT/AFL episodes (\> 30 seconds) and all-cause mortality within 12 months after one ablation procedure without antiarrhythmic medications after blanking period (3 months after ablation) as adjudicated by the independent Core Laboratory. Atrial Fibrillation (AF) Atrial Tachycardia (AT) Atrial Flutter (AFL)

  12 months

• A composite of thromboembolic events, myocardial perforation, pulmonary vein stenosis, atrioesophageal fistula, left and right phrenic nerve paralysis, and other serious adverse events within 12 months post-procedure.

  The primary safety endpoint is defined as a composite of thromboembolic events, myocardial perforation, pulmonary vein stenosis, atrioesophageal fistula, left and right phrenic nerve paralysis, and other serious adverse events within 12 months post-procedure.

  12 months

Secondary Outcomes (11)

• Incidence of peri-procedural and 12-month post procedural complications.

  12, 24 and 60 months

• AF/AT/AFL Burden

  12, 24 and 60 months

• All-cause mortality

  12, 24 and 60 months

• Atrial contractility

  6 months

• Heart failure analysis

  12, 24 and 60 months

Study Arms (4)

PVI

ACTIVE COMPARATOR

Pulmonary vein isolation alone will be performed using radiofrequency energy

Procedure: Catheter ablation

PVI + PWI

EXPERIMENTAL

Pulmonary vein isolation plus posterior wall isolation will be performed using radiofrequency energy

Procedure: Catheter ablation

PVI + PWI + LAAEI

EXPERIMENTAL

Pulmonary vein isolation plus posterior wall isolation plus left atrial appendage electrical isolation will be performed using radiofrequency energy

Procedure: Catheter ablation

PVI + PWI + LAAEI + CSI

EXPERIMENTAL

Pulmonary vein isolation plus posterior wall isolation plus left atrial appendage electrical isolation plus coronary sinus isolation will be performed using radiofrequency energy

Procedure: Catheter ablation

Interventions

Catheter ablation PROCEDURE

Catheter ablation

PVI; PVI + PWI; PVI + PWI + LAAEI; PVI + PWI + LAAEI + CSI

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 or greater
• In good general health as evidenced by medical history and diagnosed with symptomatic persistent AF or long-standing persistent AF.
• Persistent AF will be defined as a sustained episode lasting \> 7 days and less than 1 year.
• Long-standing persistent AF will be defined as a sustained episode lasting more than 1 year and less than 10 years.
• Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
• At least one episode of persistent AF must have been documented by ECG, Holter, loop recorder, ziopatch, telemetry, trans telephonic monitoring (TTM), or implantable device within last 10 years of enrollment in this investigation.
• Patients undergoing first time procedure for AF.

You may not qualify if:

• Patients with paroxysmal AF.
• Paroxysmal AF will be defined as a sustained episode lasting \< 7 days (either terminated spontaneously or with pharmacological or electrical cardioversion.
• Reversible causes of AF.
• Patients with contraindications to systemic anticoagulation with heparin or coumadin, direct thrombin inhibitor or factor Xa inhibitors.
• Patients with left atrial size ≥ 75 mm (2D echocardiography, parasternal long axis view)
• Left atrial or LAA thrombus
• Patients with severe valvular heart disease or after mitral valve replacement (bioprosthetic or mechanical).
• Patients with a life expectancy ≤ 24 months
• CHA2DS2Vasc score of 0 for men and CHA2DS2Vasc score of 1 for women.
• Patients who are pregnant.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Biosense Webster, Inc.: collaborator

Study Sites (16)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

MarinHealth Medical Center

Larkspur, California, 94904, United States

Location

University of Colorado

Boulder, Colorado, 80309, United States

Location

Miami Cardiac & Vascular Institute

Miami, Florida, 33176, United States

Location

Indiana University

Bloomington, Indiana, 47405, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

WakedMed Heart & Vascular

Raleigh, North Carolina, 27610, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Cardiac Arrhythmia Institute

Austin, Texas, 78705, United States

Location

Baylor Heart Clinic

Houston, Texas, 77030, United States

Location

Instituto Cardiovascular Adventista

Buenos Aires, Argentina

Location

Incor - HCFMUSP

São Paulo, Brazil

Location

University CES

Medellín, Antioquia, Colombia

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, Germany

Location

Hospital Santa Cruz

Lisbon, Portugal

Location

Hacettepe University

Ankara, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Atrial Fibrillation; Embolic Stroke

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jorge E Romero, MD

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Luigi Di Biase, MD, PhD

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Andrea Natale, MD

  Texas Cardiac Arrhythmia Institute and St. David's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The nature of the ablation procedures precludes blinding of physicians to patient treatment. However, patients will be blinded to their ablation strategy (single-blind design) and endpoint assessment will be made by blinded adjudicators from an independent core laboratory.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 932 patients will be randomized with equal allocation to one of four treatment groups. This sample size provides 90% power to detect pairwise differences in response rates between groups ranging from 0.12 to 0.15 based on two-tailed 0.05 level intention to treat chi-squared tests. Specifically, the response rates under the alternative upon which sample size is determined are 0.45, 0.60, 0.75, 0.87 for PVI alone, PVI + PWI, PVI + PWI + LAAEI and PVI + PWI + LAAEI + CSI respectively.

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 3, 2020
• Study Start: January 16, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); AR (1); PT (1); TU (1); US (10); BR (1); CO (1)