NCT05496088Completed
Persistent AF Catheter Ablation: Re-PVI Vs. Re-PVI + Continuous Complex Activity Mapping and Ablation - AF-CAM
Source: ClinicalTrials.gov · Last updated 28 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 27 Jun 2022
- Start date
- 3 Jun 2021
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Asklepios proresearch
- Diseases
- Atrial fibrillation
- NCT number
- NCT05496088
What you commit to
- Study type: Interventional
- Participants enrolled: 56
- From 3 Jun 2021 to the primary completion date, 31 Oct 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any cardiac surgery within the past 2 months (60 days).
- Myocardial infarction within the past 2 months (60 days).
- 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.
- 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.
- Presence of a condition that precludes vascular access.
Other
- Atrial fibrillation due to reversible causes.
- Continuous AF \> 12 months.
- Documented LA thrombus on imaging.
- LA size \>60 mm.
- Contraindication to anticoagulation (heparin or warfarin).
- Documented thromboembolic event (including TIA) within the past 12 months.
- Diagnosed atrial myxoma.
- 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.
- Patients with hemodialysis.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vivantes Klinikum am Urban Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Evangelisches Krankenhaus Duesseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Asklepios Klinik St. Georg Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.