NCT02169037

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
1.6 years until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

6.4 years

First QC Date

June 18, 2014

Last Update Submit

June 3, 2021

Conditions

Atrial Fibrillation

Keywords

RotorFIRMParoxysmal Atrial FibrillationAtrial tachyarrhythmiaAblationContact mappingClinical trialSignal processing.

Outcome Measures

Primary Outcomes (1)

  • Long term success

    Freedom from AF recurrence during 12 months after the initial AF ablation procedure, after an initial 3 month blanking (healing and stabilization) period

    12 months

Secondary Outcomes (5)

  • Long-term freedom from AF/AT

    12 months

  • Total ablation time

    1 day

  • Quality of life (QOL)

    12 months

  • Adverse events

    12 months

  • Consistency of Sources At Repeat Ablation

    2 years

Study Arms (2)

FIRM ablation

EXPERIMENTAL

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

Procedure: FIRM Ablation

Conventional AF ablation with PVI

ACTIVE COMPARATOR

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

Procedure: Conventional AF ablation with PVI

Interventions

FIRM AblationPROCEDURE

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

FIRM ablation
Conventional AF ablation with PVIPROCEDURE

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

Conventional AF ablation with PVI

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

VA San Diego Medical Center

San Diego, California, 92161, United States

RECRUITING

Related Publications (4)

  • 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; Heart Rhythm Society Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. 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: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society. Heart Rhythm. 2012 Apr;9(4):632-696.e21. doi: 10.1016/j.hrthm.2011.12.016. Epub 2012 Mar 1. No abstract available.

    PMID: 22386883BACKGROUND

  • Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18.

    PMID: 22818076BACKGROUND

  • Narayan SM, Baykaner T, Clopton P, Schricker A, Lalani GG, Krummen DE, Shivkumar K, Miller JM. Ablation of rotor and focal sources reduces late recurrence of atrial fibrillation compared with trigger ablation alone: extended follow-up of the CONFIRM trial (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation). J Am Coll Cardiol. 2014 May 6;63(17):1761-8. doi: 10.1016/j.jacc.2014.02.543. Epub 2014 Mar 13.

    PMID: 24632280BACKGROUND

  • Miller, J. M., R. C. Kowal, V. Swarup, J. P. Daubert, E. G. Daoud, J. D. Day, K. A. Ellenbogen, J. D. Hummel, T. Baykaner, D. E. Krummen, S. M. Narayan, V. Y. Reddy, K. Shivkumar, J. S. Steinberg and K. R. Wheelan (2014).

    BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sanjiv M Narayan, MD, PhD

    Stanford University

    STUDY DIRECTOR

Central Study Contacts

Sanjiv M Narayan, MD, PhD

CONTACT

6507236393

Kathleen C Mills, BA

CONTACT

6507236393

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 20, 2014

Study Start

February 1, 2016

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

June 4, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)