Paroxysmal Atrial FibrillationCF²NCT03056222
CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
A study testing Ablation catheter in people with Paroxysmal Atrial Fibrillation, run by I-Med-Pro GmbH at 11 sites in 4 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Ablation catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 10 Apr 2017to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Germany7 sites
Vivantes Klinikum Am Urban
Berlin, 10967
St. Vinzenz Hospital Köln
Cologne, North Rhine-Westphalia, 50733
Universitätsklinik Erlangen
Erlangen, Bavaria, 91054
Asklepios Klinik St. Georg
Hamburg, 20099
Universitäres Herz- und Gefäßzentrum UKE Hamburg
Hamburg, 20251
UKSH, Universitäres Herzzentrum
Lübeck, Schleswig-Holstein, 23562
Isar Herz Zentrum
München, Bavaria, 80331
Belgium2 sites
Hartcentrum OLV Aalst
Aalst, 9300
Hartcentrum Hasselt Jessa Ziekenhuis
Hasselt, 3500
About this study
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).
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Ablation catheter
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation catheterDevice
Ablation of paroxysmal atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| HeartLight® EGLA | Active comparator | Participants will be treated with the endoscopically guided laser ablation catheter Receives: Device: Ablation catheter |
| Contact Force Sensing Irrigated RF ablation | Active comparator | Participants will be treated with a contact force sensing irrigated radiofrequency ablation catheter Receives: Device: Ablation catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs
Recurrent AF is defined as any documented episode of AF lasting more than 30 seconds after a blanking period of 90 days post procedure
Measured: 12 months post procedure
Secondary outcomes (4)
Acute procedure success
Confirmation of electrical isolation with a circular mapping catheter
Measured: 30 minutes post procedure
Procedure and fluoroscopy time
Time will be taken
Measured: During procedure
Incidence of peri-procedural complications
E.g. major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thrombo-embolic events, pulmonary vein (PV) -stenosis, atrial-to-esophageal fistula, death
Measured: From procedure to 12 months post procedure
Freedom from symptomatic, recurrent Atrial Tachy Arrhythmia (ATA) off of anti-arrhythmic drugs
Recurrent ATA is defined as any documented episode of ATA lasting more than 30 seconds after a blanking period of 90 days post procedure
Measured: 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start10 Apr 2017
- Primary completion16 Aug 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- I-Med-Pro GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Metzner, PD Dr. med., Principal investigator, Universitäres Herz- und Gefäßzentrum UKE Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056222
- Sponsor's protocol ID
- CF2 Rev.1 IMP
- Acronym
- CF²
- Status last verified
- Nov 2021
- First submitted
- 14 Feb 2017
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03056222
- Acronym / sponsor ID
- CF² / CF2 Rev.1 IMP
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- I-Med-Pro GmbHUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 17 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HeartLight® EGLA | Active comparator | Device: Ablation catheterParticipants will be treated with the endoscopically guided laser ablation catheter |
| Contact Force Sensing Irrigated RF ablation | Active comparator | Device: Ablation catheterParticipants will be treated with a contact force sensing irrigated radiofrequency ablation catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation catheterAblation of paroxysmal atrial fibrillation | Device | Contact Force Sensing Irrigated RF ablation, HeartLight® EGLA |
Primary outcome
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
4 secondary outcomes
Acute procedure success
Time frame: 30 minutes post procedure
Procedure and fluoroscopy time
Time frame: During procedure
Incidence of peri-procedural complications
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: No
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A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
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A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
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Catheter Ablation Using a Novel Navigation and Imaging System
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Metzner, PD Dr. med. principal investigator
Universitäres Herz- und Gefäßzentrum UKE Hamburg
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation catheter in people with Paroxysmal Atrial Fibrillation, run by I-Med-Pro GmbH at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Belgium, Czechia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.