Atrial FibrillationPRIME-AFNCT03695484
Registry Evaluating AF Ablation Techniques
An observational study of Atrial Fibrillation and Catheter Ablation, run by Erasmus Medical Center at 3 sites in 3 countries.
Trial summary
The purpose of this observational registry is to prospectively collect procedure efficiency, safety and acute and long term outcome data from catheter ablation procedures as treatment of paroxysmal atrial fibrillation, using the following treatment modalities: Cryoballoon ablation Manual guided RF ablation using… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Catheter Ablation
- How many people
- 212 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 31 Oct 2018to 30 Jun 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients eligible for participation in the study have a reported incidence of at least two documented episodes of symptomatic paroxysmal atrial fibrillation during the three months preceding trial entry, as well as documentation of at least one episode of AF on ECG, and are eligible for PVI by catheter ablation based on the respective ACC/AHA/ESC Guideline valid at the date of procedure
Who may be able to join
- Documented Paroxysmal Atrial Fibrillation
- Eligibility for Pulmonary Vein Isolation by catheter ablation based on the respective ACC/AHA/ESC Guideline valid at the date of procedure
- Signed the informed consent to participate in the registry
Who cannot join
- Younger than 18 years of age
- Prior AF ablation procedure (including MAZE procedure)
- Prior ablation of Non-AF Arrhythmia within 3 months of enrollment
- Presence of cardiac thrombus
- Other AF ablations performed during procedure (e.g. lines, rotor, CFAE's etc)
- Active endocarditis or systemic infection
- Life expectancy < 1 year
- Pregnancy
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Prospective, Multicenter, Non-randomized Observational Registry Conducted at High Volume Experienced Treatment Centers Utilizing the Most Current AF Ablation Techniques.
The purpose of this observational registry is to prospectively collect procedure efficiency, safety and acute and long term outcome data from catheter ablation procedures as treatment of paroxysmal atrial fibrillation, using the following treatment modalities:
- Cryoballoon ablation
- Manual guided RF ablation using Contact Force catheters
- Remote Magnetic Navigation guided RF ablation with e-Contact and high power settings
- Remote Magnetic Navigation guided RF ablation with e-Contact and low power settings
- Conditions
- Atrial Fibrillation, Catheter Ablation
- Keywords
- Paroxysmal Atrial Fibrillation, Catheter Ablation, Cryoballoon, Radiofrequency ablation, Remote Magnetic Navigation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Manual guided RF ablation | Patients with paroxysmal atrial fibrillation treated with Manual guided RF ablation using Contact Force catheters | |
| Cryoballoon ablation | Patients with paroxysmal atrial fibrillation treated with Cryoballoon ablation. Cryoballoon: Arctic Front Advance, Medtronic - 28 mm | |
| RMN guided RF ablation - High power | Patients with paroxysmal atrial fibrillation treated with Remote Magnetic Navigation guided RF ablation with e-Contact and high power settings. High power ablation settings: a minimum of 40 Watt, 43grC, flow 17ml/min. Higher voltages (e.g. anterior wall) are allowed with respect to the operators' preference. | |
| RMN guided RF ablation - Low power | Patients with paroxysmal atrial fibrillation treated with Remote Magnetic Navigation guided RF ablation with e-Contact and low power settings. Low power ablation settings: a maximum of 39 Watt, 43grC, flow 17ml/min. Lower voltages are allowed with respect to the operators' preference. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure time
Procedure time (minutes)
Measured: During ablation procedure
Fluoroscopy time
Fluoroscopy time (minutes)
Measured: During ablation procedure
Transseptal time
Transseptal time (time from insertion of catheters until transseptal puncture) (minutes)
Measured: During ablation procedure
Left atrial dwell time
Left atrial dwell time (time from LA entry until removal of catheters) (minutes)
Measured: During ablation procedure
PVI ablation time
PVI ablation time (total PVI ablation time, i.e. first until last application) (minutes)
Measured: During ablation procedure
Ablation time per pulmonary vein
Ablation time per pulmonary vein (minutes)
Measured: During ablation procedure
Secondary outcomes (6)
First Pass Isolation
First Pass Isolation (i.e. Successful isolation of PVs after the first ablation attempt)
Measured: During ablation procedure
Acute success
Acute success (Successful electrical isolation of PVs at the end of procedure)
Measured: During ablation procedure
TouchUp rates
TouchUp rates (additional applications for successful PV isolation)
Measured: During ablation procedure
Long-term success
Long-term success (freedom of atrial fibrillation 12 months after ablation)
Measured: From the date of procedure until 1 year
Procedure-related adverse-events
Procedure-related adverse-events
Measured: From the date of procedure until 7 days
Long-term adverse events
Long-term adverse events
Measured: From the date of procedure until 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start31 Oct 2018
- Primary completion9 Jun 2021
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 212 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Marie Noten, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695484
- Sponsor's protocol ID
- PRIME-AF
- Acronym
- PRIME-AF
- Status last verified
- Jan 2022
- First submitted
- 20 Sep 2018
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Non-randomized Observational Registry Conducted at High Volume Experienced Treatment Centers Utilizing the Most Current AF Ablation Techniques.
- ClinicalTrials.gov ID
- NCT03695484
- Acronym / sponsor ID
- PRIME-AF / PRIME-AF
- Conditions
- Atrial Fibrillation, Catheter Ablation
- Keywords
- Paroxysmal Atrial Fibrillation, Catheter Ablation, Cryoballoon, Radiofrequency ablation, Remote Magnetic Navigation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 4 Oct 2018 (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 purpose of this observational registry is to prospectively collect procedure efficiency, safety and acute and long term outcome data from catheter ablation procedures as treatment of paroxysmal atrial fibrillation, using the following treatment modalities:
- Cryoballoon ablation
- Manual guided RF ablation using Contact Force catheters
- Remote Magnetic Navigation guided RF ablation with e-Contact and high power settings
- Remote Magnetic Navigation guided RF ablation with e-Contact and low power settings
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Manual guided RF ablation | – | –Patients with paroxysmal atrial fibrillation treated with Manual guided RF ablation using Contact Force catheters |
| Cryoballoon ablation | – | –Patients with paroxysmal atrial fibrillation treated with Cryoballoon ablation. Cryoballoon: Arctic Front Advance, Medtronic - 28 mm |
| RMN guided RF ablation - High power | – | –Patients with paroxysmal atrial fibrillation treated with Remote Magnetic Navigation guided RF ablation with e-Contact and high power settings. High power ablation settings: a minimum of 40 Watt, 43grC, flow 17ml/min. Higher voltages (e.g. anterior wall) are allowed with respect to the operators' preference. |
| RMN guided RF ablation - Low power | – | –Patients with paroxysmal atrial fibrillation treated with Remote Magnetic Navigation guided RF ablation with e-Contact and low power settings. Low power ablation settings: a maximum of 39 Watt, 43grC, flow 17ml/min. Lower voltages are allowed with respect to the operators' preference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for participation in the study have a reported incidence of at least two documented episodes of symptomatic paroxysmal atrial fibrillation during the three months preceding trial entry, as well as documentation of at least one episode of AF on ECG, and are eligible for PVI by catheter ablation based on the respective ACC/AHA/ESC Guideline valid at the date of procedure
Key inclusion criteria (3 listed)
- Documented Paroxysmal Atrial Fibrillation
- Eligibility for Pulmonary Vein Isolation by catheter ablation based on the respective ACC/AHA/ESC Guideline valid at the date of procedure
- Signed the informed consent to participate in the registry
Key exclusion criteria (8 listed)
- Younger than 18 years of age
- Prior AF ablation procedure (including MAZE procedure)
- Prior ablation of Non-AF Arrhythmia within 3 months of enrollment
- Presence of cardiac thrombus
- Other AF ablations performed during procedure (e.g. lines, rotor, CFAE's etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Procedure time
Time frame: During ablation procedure
Procedure time (minutes)
Fluoroscopy time
Time frame: During ablation procedure
Fluoroscopy time (minutes)
Transseptal time
Time frame: During ablation procedure
Transseptal time (time from insertion of catheters until transseptal puncture) (minutes)
Left atrial dwell time
Time frame: During ablation procedure
Left atrial dwell time (time from LA entry until removal of catheters) (minutes)
PVI ablation time
Time frame: During ablation procedure
PVI ablation time (total PVI ablation time, i.e. first until last application) (minutes)
Ablation time per pulmonary vein
Time frame: During ablation procedure
Ablation time per pulmonary vein (minutes)
6 secondary outcomes
First Pass Isolation
Time frame: During ablation procedure
Acute success
Time frame: During ablation procedure
TouchUp rates
Time frame: During ablation procedure
Long-term success
Time frame: From the date of procedure until 1 year
Procedure-related adverse-events
Time frame: From the date of procedure until 7 days
Long-term adverse events
Time frame: From the date of procedure until 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Catheter Ablation, run by Erasmus Medical Center at 3 sites in 3 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Netherlands, Russia. 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?
Results are not available in the source record.
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?
Procedure time (time frame: During ablation procedure). The study lists 6 primary outcomes in all. 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 26 Jan 2022.