Recruiting

Substrate vs. Trigger

Sponsor:

UCLA

Code:

NCT02169037

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

FIRM Ablation

Conventional AF ablation with PVI

Study Details

Brief summary:

This is a prospective randomized study to assess the safety and efficacy of FIRM (Focal Impulse and Rotor Modulation)-guided ablation for the treatment of symptomatic atrial fibrillation (AF). The study hypothesis is that the efficacy of AF elimination at 1 year will be higher by ablating patient-specific AF-sustaining rotors and focal sources by Focal Impulse and Rotor Modulation (FIRM) compared to conventional ablation alone (wide-area PV isolation).

Conditions

Atrial Fibrillation

Study ID

NCT02169037

Start date

Feb 1, 2016

Status verified date

Jun, 2021

Completion date

Jul 1, 2022

Anticipated

Primary completion date

Jul 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

INCLUSION CRITERIA:

  • male or female >21 years
  • reported incidence of at least two documented episodes of symptomatic paroxysmal atrial fibrillation (AF) during the three months preceding trial entry (at least 1 episode documented by 12-lead ECG or ECG rhythm strip)
  • women without childbearing potential or women of childbearing potential who are not pregnant per a serum HCG test
  • refractory to at least one Class I or III anti-arrhythmic medications. Drug doses must be therapeutic and stable
  • willingness, ability and commitment to participate in baseline and follow-up evaluations without participation in another clinical trial (unless documented approval received from both sponsors)
  • oral anticoagulation required for those subjects who have a score of two or more based on the following criteria (CHAD score):

  • Congestive heart failure (1 point)
  • hypertention (1 point)
  • age 75 years or older (2 points)
  • diabetes (1 point)
  • prior stroke or transient ischemic attack (2 points)
  • vascular disease (1 point)
  • age 65 years or older (1 point)
  • sex category: female (1 point)
  • patient is willing and able to remain on anti-coagulation therapy for a minimum of 3 months post procedure for all subjects, and potentially indefinitely post procedure if the patient has CHAD score >or=2
  • signed informed consent after a full discussion of the risks and benefits of both therapy arms, and the concept of randomization
  • NYHA Class 0,I, II stable on medical therapy for > 3months
  • left atrial diameter <or= 5.5cm
  • LVEF >or=40%
  • sustained AF during the procedure

EXCLUSION CRITERIA:

  • atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, pericarditis)
  • cardiac or thoracic surgery within the past 180 days
  • AF secondary to electrolyte imbalance, thyroid disease
  • contraindication to Heparin
  • Contraindication to Warfarin or other novel oral anticoagulants
  • history of significant bleeding abnormalities
  • history of significant blood clotting abnormalities, systemic thrombi or systemic embolization
  • ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve
  • atrial clot/thrombus on imaging such as on a trans-esophageal echocardiogram (TEE) within 72 hours of the procedure
  • intramural thrombus or other cardiac mass that may adversely effect catheter introduction or manipulation
  • significant pulmonary embolus within 6 months of enrollment
  • acute illness or active systemic infection or sepsis that may ordinarily warrant postponement of the procedure
  • history of recent cerebrovascular disease (stroke or TIA) or systemic thromboembolism within < 6 months
  • NYHA classes III, IV
  • heart failure that is not stable on medical therapy
  • pulmonary edema, that may make planned anesthesia or sedation difficult
  • stable/unstable angina or ongoing myocardial ischemia
  • myocardial infarction (MI) within the past three months
  • structural heart disease of clinical significance including:

  • congenital heart disease where the abnormality or its correction prohibit or increase the risk of ablation
  • acquired heart disease that may increase risk of ablation, such as significant ventricular septal defect post myocardial infarction
  • rheumatic valve disease, since this produces a unique AF phenotype
  • extreme left atrial enlargement (LA volume index > 60 ml/m2) in whom PVI has low success and 55 mm baskets are too small for the atria
  • cardiac transplantation or other cardiac surgery planned within the 12 month followup period of the trial
  • life expectancy less than 12 months (the followup period of the trial)
  • significant pulmonary disease (e.g., COPD) or any other disease that significantly increase the risk to the patient from sedation or anesthesia
  • untreatable allergy to contrast media
  • at time of ablation procedure, clinically significant abnormalities in serum potassium, sodium, magnesium or other electrolytes that affect the suitability of the patient for ablation at that time

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FIRM ablation

These patients will be treated by ablation of patient-specific rotors and focal sources (FIRM) alone.

active comparator: Conventional AF ablation with PVI

These patients will treated by conventional AF ablation by pulmonary vein isolation (PVI) alone.

Interventions

FIRM Ablation

Substrate ablation for AF, via ablation of rotors and focal sources alone.

Conventional AF ablation with PVI

Trigger Based Ablation for AF, using Pulmonary Vein Isolation alone.

Primary outcome measure

  • Long term success [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Sanjiv M Narayan, MD, PhD

6507236393

Kathleen C Mills, BA

6507236393

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Paul J Wang, MD

pjwang@stanford.edu

Principal Investigator:

Paul J Wang, MD

VA San Diego Medical Center

Recruiting

San Diego, California, United States, 92161

Contacts

David E Krummen, MD

858-552-8585

More Information

Sponsor

University of California, San Diego

Last update posted

Jun 4, 2021

Last verified

Jun, 2021

Keywords

  • Rotor
  • FIRM
  • Paroxysmal Atrial Fibrillation
  • Atrial tachyarrhythmia
  • Ablation
  • Contact mapping
  • Clinical trial
  • Signal processing.

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2021-06-04.