NCT02386345

Brief Summary

This is a registry to assess the safety and effectiveness of FIRM guided procedures for the treatment of symptomatic any type of atrial fibrillation. FIRM (Focal Impulse and Rotor Modulation) guided ablation is defined as ablating rotors identified by the FIRMap® basket catheter for visualising of rotors with the RhythmView® mapping system. In addition to the FIRM guided ablation any other ablation method could be applied.The acute success of FIRM ablations is defined as elimination of rotors defined by absence of rotors. Data items will be collected, if available, consistent and applicable with routine and standard clinical care at each participating site.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
299

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
2 countries

9 active sites

Status
completed

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

Study Start

First participant enrolled

March 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 15, 2019

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

2.3 years

First QC Date

March 2, 2015

Results QC Date

September 17, 2019

Last Update Submit

January 6, 2020

Conditions

Atrial Fibrillation

Keywords

FIRM procedure

Outcome Measures

Primary Outcomes (4)

  • Number of Participants With Acute Success

    Acute Success was defined as the elimination (by ablation) of all identified rotors

    day of procedure

  • Number of Participants With 12-Month Success

    Single procedure freedom from atrial fibrillation recurrence

    12-months after index procedure

  • Number of Participants With Acute Safety Success

    Acute safety success was defined as freedom from Serious Adverse Events at 7 days after index procedure

    7 days after index procedure

  • Number of Participants With 12-Month Safety Success

    Success was defined as freedom from Serious Adverse Events at 12-months after index procedure

    12-months after index procedure

Other Outcomes (1)

  • Number of Participants With 6-Month Safety Success

    6-months after index procedure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who are receiving a FIRM guided AF ablation and are selected in accordance with the current AF guidelines are eligible for the participation in the registry

You may qualify if:

  • reported incidence of at least 2 documented episodes of symptomatic AF (paroxysmal, persistent or long standing persistent) during the 3 months preceding the initial AF ablation attempt of at least one Class I or III anti-arrhythmia drug with failure defined as recurrence of symptomatic AF or adverse drug effect resulting in stopping medication

You may not qualify if:

  • women who are pregnant
  • As this is a registry only data of patients will be included who have been treated according to the current AF guidelines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Städtisches Klinikum Karlsruhe GmbH

Karlsruhe, Baden-Würtemberg, 76133, Germany

Location

Herz- und Gefäßklinik

Bad Neustadt an der Saale, Bavaria, 97616, Germany

Location

Klinikum Coburg GmbH

Coburg, Bavaria, 96450, Germany

Location

Kardiologische Gemeinschaftspraxis am Park Sanssouci

Potsdam, Brandenburg, 14471, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR

Dresden, Saxony, 01099, Germany

Location

Herzzentrum Leipzig

Leipzig, Saxony, 04289, Germany

Location

Unfallkrankenhaus Berlin

Berlin, 12683, Germany

Location

Erasmus Medical Center

Rotterdam, 3015, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Clinical Program Director
Organization
Abbott
kristin.ruffner@abbott.com
6517566717

Study Officials

  • Gerhard Hindricks, Prof. Dr.

    Herzzentrum Leipzig - Universitätsklinik

    PRINCIPAL INVESTIGATOR

  • Kristin Ruffner, PhD

    Abbott

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 11, 2015

Study Start

March 1, 2015

Primary Completion

May 31, 2017

Study Completion

July 31, 2018

Last Updated

January 14, 2020

Results First Posted

October 15, 2019

Record last verified: 2020-01

Locations

DE(8)NL(1)