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Persistent AF Catheter Ablation: Re-PVI vs. Re-PVI + Continuous Complex Activity Mapping and Ablation - AF-CAM (AF-CAM)

Primary Purpose

Atrial Fibrillation

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Re-PVI only

Re-PVI + substrate ablation

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Ablation strategy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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).
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.

Sites / Locations

Asklepios Klinik St. GeorgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group 1: Re-PVI only

Group 2: Re-PVI + substrate ablation

Arm Description

Repeat ablation of pulmonary veins (Re-PVI), followed by electrical cardioversion if AF persists, n=100 pts

Repeat ablation of pulmonary veins (Re-PVI) + mapping & ablation of areas of continuous, complex activity, n=100 pts

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05496088

First Posted

June 27, 2022

Last Updated

August 9, 2022

Sponsor

Asklepios proresearch

Collaborators

Asklepios Klinik St. Georg, Evangelisches Krankenhaus Düsseldorf

1. Study Identification

Unique Protocol Identification Number

NCT05496088

Brief Title

Persistent AF Catheter Ablation: Re-PVI vs. Re-PVI + Continuous Complex Activity Mapping and Ablation - AF-CAM

Acronym

AF-CAM

Official Title

Persistent AF Catheter Ablation: Re-PVI vs. Re-PVI + Continuous Complex Activity Mapping and Ablation - AF-CAM

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 3, 2021 (Actual)

Primary Completion Date

July 1, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Asklepios proresearch

Collaborators

Asklepios Klinik St. Georg, Evangelisches Krankenhaus Düsseldorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Ablation strategy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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: RePVI only: Re-PVI (followed by cardioversion if AF persists) RePVI + substrate ablation: Re-PVI followed by ablation of areas of complex, continuous activity (followed by cardioversion if AF persists).

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Re-PVI only

Arm Type

Active Comparator

Arm Description

Repeat ablation of pulmonary veins (Re-PVI), followed by electrical cardioversion if AF persists, n=100 pts

Arm Title

Group 2: Re-PVI + substrate ablation

Arm Type

Active Comparator

Arm Description

Repeat ablation of pulmonary veins (Re-PVI) + mapping & ablation of areas of continuous, complex activity, n=100 pts

Intervention Type

Procedure

Intervention Name(s)

Re-PVI only

Other Intervention Name(s)

Repeat-PVI followed by electrocardioversion if AF persists

Intervention Description

Comparison of two treatment strategies of persistent AF catheter ablation: Re-PVI vs. Re-PVI + continuous complex activity mapping and ablation.

Intervention Type

Procedure

Intervention Name(s)

Re-PVI + substrate ablation

Other Intervention Name(s)

Repeat-PVI followed by mapping & ablation of areas of continuous, complex activity

Intervention Description

Comparison of two treatment strategies of persistent AF catheter ablation: Re-PVI vs. Re-PVI + continuous complex activity mapping and ablation.

Primary Outcome Measure Information:

Title

Freedom from atrial arrhythmia

Description

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

Time Frame

through 3 to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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). 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stephan Willems, MD, PhD

Phone

+49-40-181885-3069

s.willems@asklepios.com

First Name & Middle Initial & Last Name or Official Title & Degree

Nele Gessler, MD, PhD

Phone

+49-40-181885-3069

n.gessler@asklepios.com

Facility Information:

Facility Name

Asklepios Klinik St. Georg

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephan Willems, MD, PhD

Phone

+4940-181885-3069

s.willems@asklepios.com

First Name & Middle Initial & Last Name & Degree

Nele Gessler, MD, PhD

Phone

+49-40-181885-3069

n.gessler@asklepios.com

12. IPD Sharing Statement

Learn more about this trial

Persistent AF Catheter Ablation: Re-PVI vs. Re-PVI + Continuous Complex Activity Mapping and Ablation - AF-CAM

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