Atrial FibrillationAF-CAMNCT05496088
Persistent AF Catheter Ablation: Re-PVI Vs. Re-PVI + Continuous Complex Activity Mapping and Ablation - AF-CAM
A study testing Re-PVI only and Re-PVI + substrate ablation in people with Atrial Fibrillation, run by Asklepios proresearch at 3 sites in Germany.
Trial summary
Major objective is to compare the efficacy of adding additional ablation step (targeting areas of complex, continuous electrical activity in LA) beyond Re-PVI during catheter ablation of Atrial Fibrillation (AF) in patients undergoing 2nd ablation procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Re-PVI only and Re-PVI + substrate ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 3 sitesGermany
- Study dates
- 3 Jun 2021to 31 Jan 2025
- 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
- Patients with persistent atrial fibrillation, defined as atrial fibrillation which is:
- Sustained beyond 7 days but no more than one year.
- Or lasting less than 7 days, but with at least one episode longer than 48 h and necessitating pharmacologic or electrical cardioversion.
- Documentation of atrial fibrillation on either a 12-lead ECG or ambulatory holter monitoring or telemetry strip.
- One previous PVI only procedure in 3 years previous, but not within the last 3 months.
- Age 18 - 80 years.
- Patient is willing to participate in the study (signed written informed consent)
- Patient is willing and available to perform all follow ups.
Who cannot join
- Atrial fibrillation due to reversible causes.
- Continuous AF > 12 months.
- Any cardiac surgery within the past 2 months (60 days).
- Documented LA thrombus on imaging.
- LA size >60 mm.
- Contraindication to anticoagulation (heparin or warfarin).
Show all 21Show fewer
- Myocardial infarction within the past 2 months (60 days).
- Documented thromboembolic event (including TIA) within the past 12 months.
- Rheumatic Heart Disease.
- Uncontrolled heart failure or NYHA function class III or IV.
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days).
- Unstable angina.
- Acute illness or active systemic infection or sepsis.
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Diagnosed atrial myxoma.
- Significant severe pulmonary disease, (eg, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
- Women who are pregnant (as evidenced by pregnancy test if pre- menopausal).
- Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
- Presence of a condition that precludes vascular access.
- Patients with hemodialysis.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Vivantes - Klinikum Am Urban
Berlin, 10967
Evangelisches Krankenhaus Duesseldorf
Düsseldorf, 40217
Asklepios Klinik St. Georg
Hamburg, 20099
About this study
Major objective is to compare the efficacy of adding additional ablation step (targeting areas of complex, continuous electrical activity in LA) beyond Re-PVI during catheter ablation of Atrial Fibrillation (AF) in patients undergoing 2nd ablation procedure.
Underlying hypothesis that in addition, to Re-PVI, an ablation step targeting areas of complex continuous activity will increase atrial arrhythmias freedom compared to Re-PVI only ablation.
Read the detailed description
Catheter ablation of atrial fibrillation (AF) became first-line therapy in patients not responding to electrical or pharmacological cardioversion. In case of paroxysmal AF, pulmonary vein isolation (PVI) aiming at complete electrical isolation is recommended due to high acute and long term success rates. However, once AF becomes persistent, ablation efficiency dramatically decreases, most likely due to advanced electrical and structural remodeling of the atria.
Some studies, most notably STAR AF II and CHASE AF suggested that additional ablation beyond PVI may not benefit patients as expected. In parallel to studies questioning additional ablation, several studies exploring novel promising techniques were published reporting positive results, e.g. high frequency source ablation, electrogram complexity guided ablation, low voltage amplitude, activation dispersion guided ablation, stepwise ablation approach, autonomic ganglia modification and techniques of identification of rotating waves and point sources to name just few.
Such contrasting studies left EP community confused with regards to the strength of reported claims and practical recommendations. Thus, presently, there is no standard approach to AF substrate ablation and specifics regarding targets and technique are left to physician discretion, most likely resulting in a delivery of unnecessary treatment and obstructing identification of valuable approaches. Thus, there is a need for further studies exploring additional ablation techniques in a rigorous, randomized studies.
- Conditions
- Atrial Fibrillation
- Being tested
- Re-PVI only, Re-PVI + substrate ablation
- Keywords
- Ablation strategy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-PVI onlyProcedure or surgery
Also called Repeat-PVI followed by electrocardioversion if AF persists
Comparison of two treatment strategies of persistent AF catheter ablation:
Re-PVI vs. Re-PVI + continuous complex activity mapping and ablation.
Re-PVI + substrate ablationProcedure or surgery
Also called Repeat-PVI followed by mapping & ablation of areas of continuous, complex activity
Comparison of two treatment strategies of persistent AF catheter ablation:
Re-PVI vs. Re-PVI + continuous complex activity mapping and ablation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Re-PVI only | Active comparator | Repeat ablation of pulmonary veins (Re-PVI), followed by electrical cardioversion if AF persists, n=100 pts Receives: Procedure: Re-PVI only |
| Group 2: Re-PVI + substrate ablation | Active comparator | Repeat ablation of pulmonary veins (Re-PVI) + mapping \& ablation of areas of continuous, complex activity, n=100 pts Receives: Procedure: Re-PVI only; Procedure: Re-PVI + substrate ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial arrhythmia
Freedom from any form of sustained atrial arrhythmia (>30 s) follow-up on either a 12 lead ECG on visits or on 48h holter monitoring or on symptom driven event monitoring
Measured: through 3 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start3 Jun 2021
- Primary completion31 Oct 2024
- Study completion31 Jan 2025
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.
- 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
- Model description
- The study is a prospective, randomized, open-label, blinded endpoint, multi-center study to compare the efficacy of adding additional ablation step (targeting areas of complex, continuous electrical activity in LA) beyond Re-PVI during catheter ablation of Atrial Fibrillation (AF) in patients undergoing 2nd ablation procedure. Trial flow Patients fitting the enrollment criteria and signing the informed consent form will be included and will undergo the Redo procedure for catheter ablation of pers. AF. After Re-PVI only patients with ongoing or inducted AF will be randomized. Patients, who do not fulfill this intraprocedural criteria for randomization will not be randomized but be treated as dropouts. Randomization is based on a 1:1 ratio into two study arms: 1. RePVI only: Re-PVI (followed by cardioversion if AF persists) 2. RePVI + substrate ablation: Re-PVI followed by ablation of areas of complex, continuous activity (followed by cardioversion if AF persists).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepios proresearch
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asklepios Klinik St. Georg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496088
- Sponsor's protocol ID
- #3759
- Acronym
- AF-CAM
- Status last verified
- Feb 2025
- First submitted
- 27 Jun 2022
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent AF Catheter Ablation: Re-PVI Vs. Re-PVI + Continuous Complex Activity Mapping and Ablation - AF-CAM
- ClinicalTrials.gov ID
- NCT05496088
- Acronym / sponsor ID
- AF-CAM / #3759
- Conditions
- Atrial Fibrillation
- Keywords
- Ablation strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Asklepios proresearchIndustry (pharma, biotech, devices)
- Collaborators
- Asklepios Klinik St. Georg
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 11 Aug 2022 (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.
Major objective is to compare the efficacy of adding additional ablation step (targeting areas of complex, continuous electrical activity in LA) beyond Re-PVI during catheter ablation of Atrial Fibrillation (AF) in patients undergoing 2nd ablation procedure.
Underlying hypothesis that in addition, to Re-PVI, an ablation step targeting areas of complex continuous activity will increase atrial arrhythmias freedom compared to Re-PVI only ablation.
Detailed description
Catheter ablation of atrial fibrillation (AF) became first-line therapy in patients not responding to electrical or pharmacological cardioversion. In case of paroxysmal AF, pulmonary vein isolation (PVI) aiming at complete electrical isolation is recommended due to high acute and long term success rates. However, once AF becomes persistent, ablation efficiency dramatically decreases, most likely due to advanced electrical and structural remodeling of the atria.
Some studies, most notably STAR AF II and CHASE AF suggested that additional ablation beyond PVI may not benefit patients as expected. In parallel to studies questioning additional ablation, several studies exploring novel promising techniques were published reporting positive results, e.g. high frequency source ablation, electrogram complexity guided ablation, low voltage amplitude, activation dispersion guided ablation, stepwise ablation approach, autonomic ganglia modification and techniques of identification of rotating waves and point sources to name just few.
Such contrasting studies left EP community confused with regards to the strength of reported claims and practical recommendations. Thus, presently, there is no standard approach to AF substrate ablation and specifics regarding targets and technique are left to physician discretion, most likely resulting in a delivery of unnecessary treatment and obstructing identification of valuable approaches. Thus, there is a need for further studies exploring additional ablation techniques in a rigorous, randomized studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a prospective, randomized, open-label, blinded endpoint, multi-center study to compare the efficacy of adding additional ablation step (targeting areas of complex, continuous electrical activity in LA) beyond Re-PVI during catheter ablation of Atrial Fibrillation (AF) in patients undergoing 2nd ablation procedure. Trial flow Patients fitting the enrollment criteria and signing the informed consent form will be included and will undergo the Redo procedure for catheter ablation of pers. AF. After Re-PVI only patients with ongoing or inducted AF will be randomized. Patients, who do not fulfill this intraprocedural criteria for randomization will not be randomized but be treated as dropouts. Randomization is based on a 1:1 ratio into two study arms: 1. RePVI only: Re-PVI (followed by cardioversion if AF persists) 2. RePVI + substrate ablation: Re-PVI followed by ablation of areas of complex, continuous activity (followed by cardioversion if AF persists).
| Arm | Type | Receives |
|---|---|---|
| Group 1: Re-PVI only | Active comparator | Procedure: Re-PVI onlyRepeat ablation of pulmonary veins (Re-PVI), followed by electrical cardioversion if AF persists, n=100 pts |
| Group 2: Re-PVI + substrate ablation | Active comparator | Procedure: Re-PVI only, Procedure: Re-PVI + substrate ablationRepeat ablation of pulmonary veins (Re-PVI) + mapping \& ablation of areas of continuous, complex activity, n=100 pts |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with persistent atrial fibrillation, defined as atrial fibrillation which is:
- Documentation of atrial fibrillation on either a 12-lead ECG or ambulatory holter monitoring or telemetry strip.
- One previous PVI only procedure in 3 years previous, but not within the last 3 months.
- Age 18 - 80 years.
- Patient is willing to participate in the study (signed written informed consent)
Key exclusion criteria (21 listed)
- Atrial fibrillation due to reversible causes.
- Continuous AF > 12 months.
- Any cardiac surgery within the past 2 months (60 days).
- Documented LA thrombus on imaging.
- LA size >60 mm.
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 |
|---|---|---|
| Re-PVI onlyAlso: Repeat-PVI followed by electrocardioversion if AF persistsComparison of two treatment strategies of persistent AF catheter ablation: Re-PVI vs. Re-PVI + continuous complex activity mapping and ablation. | Procedure or surgery | Group 1: Re-PVI only, Group 2: Re-PVI + substrate ablation |
| Re-PVI + substrate ablationAlso: Repeat-PVI followed by mapping & ablation of areas of continuous, complex activityComparison of two treatment strategies of persistent AF catheter ablation: Re-PVI vs. Re-PVI + continuous complex activity mapping and ablation. | Procedure or surgery | Group 2: Re-PVI + substrate ablation |
Primary outcome
Freedom from atrial arrhythmia
Time frame: through 3 to 12 months
Freedom from any form of sustained atrial arrhythmia (>30 s) follow-up on either a 12 lead ECG on visits or on 48h holter monitoring or on symptom driven event monitoring
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 28 Feb 2025.
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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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-PVI only and Re-PVI + substrate ablation in people with Atrial Fibrillation, run by Asklepios proresearch at 3 sites in Germany.
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 8 inclusion and 21 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 28 Feb 2025. 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 Germany. 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 atrial arrhythmia (time frame: through 3 to 12 months). 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 28 Feb 2025.