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OpenTrials
Completed

NCT Number: NCT02274857

Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures

The study is a prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM procedures followed by conventional ablation including PVI versus a standard PVI procedure for the treatment of persistent atrial fibrillation (AF).

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herz- und Diabeteszentrum Bad Oeynhausen, Bad Oeynhausen, Minden-Lübbecke, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • At least two (2) documented episodes of persistent atrial fibrillation during prior 3 months
  • Refractory, intolerant, or contraindicated to Class I or III anti-arrhythmic medications
  • Left atrial diameter < 6.0 cm

Key Exclusion Criteria:

  • Previous AF Ablation
  • Presence of structural heart disease
  • New York Heart Association (NYHA) Class IV.
  • Ejection fraction < 35%.
  • History of myocardial infarction (MI) within the past three months.

Treatment and study plan

Standard PVI Ablation

Procedure

Standard PVI procedure without FIRMap.

Other names: Pulmonary vein isolation, Ablation, Arrhythmia, Persistent atrial fibrillation, Mapping

FIRM-Guided Procedure and PVI

Procedure

FIRM-guided procedure followed by conventional ablation including PVI.

Other names: Pulmonary vein isolation, Ablation, Arrhythmia, Persistent atrial fibrillation, Mapping, FIRMap

Primary outcomes

  1. Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure

    Time frame: Within 7-10 days of the Procedure

  2. Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.

    Time frame: 3-month follow up

  3. Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.

    Time frame: 3-12 months post study treatment

  4. Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure

    Time frame: 3 to 12 months post study treatment

Secondary outcomes

  1. Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts

    Time frame: Immediately post procedure

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (REAFFIRM)

Acronym: REAFFIRM

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 24, 2014
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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