FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

NCT02703454 | Terminated Results DMC

• 1 other identifier: CLN - 107
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed as a prospective, multicenter, single-blind, randomized study to assess the safety and effectiveness of FIRM-guided radiofrequency (RF) ablation procedures for the treatment of symptomatic paroxysmal atrial fibrillation (PAF). The subjects will be blinded to study treatment for the duration of the study period.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure

  Freedom from AF/AT recurrence is defined as no documented episodes of AF/AT \> 30 seconds with conventional non-invasive monitoring. In the case of a cardiac implanted electronic device (CIED), freedom from AF recurrence is defined as no documented episodes of AF/AT \> 30 seconds in a 72-hour window at the follow-up visits in addition to any symptomatic episodes with documented AF \> 30 seconds. AT recurrence does not include episodes of cavotricuspid isthmus (CTI) dependent flutter.

  3 -12 months post study treatment.

Secondary Outcomes (1)

• Number of Participants With Freedom From Procedure-related Serious Adverse Events

  Within 1 year post study treatment

Study Arms (2)

FIRM-only

EXPERIMENTAL

Subjects in this arm will be treated with FIRM-guided RF ablation without pulmonary vein isolation (PVI).

Procedure: FIRM-guided RF ablation

Conventional

ACTIVE COMPARATOR

Subjects in this arm will undergo conventional radio frequency (RF) ablation with confirmation of PVI.

Procedure: Conventional RF ablation

Interventions

FIRM-guided RF ablation PROCEDURE

FIRM-only

Conventional RF ablation PROCEDURE

Conventional

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experiencing at least two (2) documented episodes of paroxysmal atrial fibrillation in the last 3 months preceding study entry with clinical indication for atrial fibrillation (AF) ablation per guidelines. At least one episode should be documented by rhythm strip or ECG.
• Indicated for AF ablation according to current European Heart Rhythm Association (EHRA) guidelines.
• Prescribed with oral anticoagulation therapy, in indicated patients per the latest EHRA guidelines.
• Willingness and able to remain on anti-coagulation therapy as per the latest EHRA guidelines.
• Left atrial diameter \< 5.5 cm as measured and image ((computed tomography (CT)/ transesophageal echocardiogram (TEE)/ transthoracic echocardiogram (TTE)/ magnetic resonance imaging (MRI) or intracardiac echocardiography (ICE)) documented within previous six months up to pre-procedure.
• Sustained AF (\>5 min uninterrupted) during the electrophysiology procedure. If the subject is not experiencing spontaneous, sustained AF, it may be induced by burst pacing (typically from the coronary sinus) with or without isoproterenol infusion in conventional clinical fashion.

You may not qualify if:

• New York Heart Association heart failure (NYHA) Class III - IV.
• Ejection fraction \< 40% (within previous six months).
• History of myocardial infarction (MI) within the past three months.
• Any concomitant arrhythmia or therapy that could interfere with the interpretation of the results from this study.
• Atrial septal defect (ASD) closure device, left atrial appendage (LAA) closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker.
• Any previous AF catheter ablation.
• History of prior cardioversion for AF lasting \> 48 hours.
• Continuous AF episode lasting \> 7 days immediately prior to the procedure without a sinus rhythm.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Universitäres Herzzentrum Lübeck

Lübeck, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Early termination led to small numbers of subjects analyzed

Results Point of Contact

• Title: Clinical Program Director
• Organization: Abbott

kristin.ruffner@abbott.com

6517566717

Study Officials

• Roland R. Tilz, PD Dr. med.

  Universität zu Lübeck

  PRINCIPAL INVESTIGATOR

• Phillipp Sommer, PD Dr. med.

  University of Leipzig

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 9, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: May 21, 2019
• Results First Posted: May 21, 2019

Record last verified: 2019-05

Locations

DE (1)