CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation (CF²)

November 18, 2021 updated by: I-Med-Pro GmbH
The aim of the study is to compare the acute procedure and safety outcomes as well as long term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Hartcentrum OLV Aalst
      • Hasselt, Belgium, 3500
        • Hartcentrum Hasselt Jessa Ziekenhuis
  • Czechia
      • Prague, Czechia, 15030
        • Nemocnice na Homolce
  • Germany
      • Berlin, Germany, 10967
        • Vivantes Klinikum am Urban
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg
      • Hamburg, Germany, 20251
        • Universitäres Herz- und Gefäßzentrum UKE Hamburg
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Universitätsklinik Erlangen
      • München, Bavaria, Germany, 80331
        • Isar Herz Zentrum
    • NRW
      • Köln, NRW, Germany, 50733
        • St. Vinzenz Hospital Köln
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23562
        • UKSH, Universitäres Herzzentrum
  • United Kingdom
      • Blackpool, United Kingdom, FY3 8NR
        • Blackpool Victoria Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient must not have undergone a previous ablation for the treatment of PAF
  • AF Type - Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) where PAF is defined as recurrent (two or more) episodes of AF that terminate spontaneously in less than seven days, usually less than 48 hours

Exclusion Criteria:

  • Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
  • Diagnosed with persistent atrial fibrillation defined as recurrent episodes lasting more than 7 and less than 365 days
  • More than 4 electrical cardioversions in the year prior to enrollment but not including cardioversions performed within 48 hours of arrhythmia onset
  • Documented left atrial thrombus on imaging
  • Cannot be removed from anti-arrhythmic drugs for other reasons than atrial fibrillation
  • New York Heart Association (NYHA) functional Class III or Class IV heart failure
  • Left ventricular ejection fraction < 30%
  • Left atrial size > 55 mm as measured in the parasternal antero-posterior view
  • Myocardial infarction within 60 days prior to enrolment
  • Woman of childbearing potential who is pregnant, lactating or not using adequate birth control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: HeartLight® EGLA
Participants will be treated with the endoscopically guided laser ablation catheter
Device: Ablation catheter
Ablation of paroxysmal atrial fibrillation
Active Comparator: Contact Force Sensing Irrigated RF ablation
Participants will be treated with a contact force sensing irrigated radiofrequency ablation catheter
Device: Ablation catheter
Ablation of paroxysmal atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs
Time Frame: 12 months post procedure
Recurrent AF is defined as any documented episode of AF lasting more than 30 seconds after a blanking period of 90 days post procedure
12 months post procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute procedure success
Time Frame: 30 minutes post procedure
Confirmation of electrical isolation with a circular mapping catheter
30 minutes post procedure
Procedure and fluoroscopy time
Time Frame: During procedure
Time will be taken
During procedure
Incidence of peri-procedural complications
Time Frame: From procedure to 12 months post procedure
E.g. major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thrombo-embolic events, pulmonary vein (PV) -stenosis, atrial-to-esophageal fistula, death
From procedure to 12 months post procedure
Freedom from symptomatic, recurrent Atrial Tachy Arrhythmia (ATA) off of anti-arrhythmic drugs
Time Frame: 12 months post procedure
Recurrent ATA is defined as any documented episode of ATA lasting more than 30 seconds after a blanking period of 90 days post procedure
12 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
I-Med-Pro GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreas Metzner, PD Dr. med., Universitäres Herz- und Gefäßzentrum UKE Hamburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CF2 Rev.1 IMP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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