Impact of Catheter Ablation on ABC Risk Scores

NCT05635864 | Completed

• 1 other identifier: 9112_BO_S_2020
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective, monocentric, non-randomized trial is to investigate the impact of catheter ablation of atrial tachyarrhythmias on the ABC-stroke and ABC-bleeding risk scores. Participants planned for first catheter ablation for symptomatic atrial tachyarrrhythmias (atrial fibrillation, atrial flutter) will be enrolled. Serial blood samples will be collected before and 3, 6 and 12 months after catheter ablation to calculate the ABC scores as well as the traditional bleeding and stroke risks. Following catheter ablation, continuous rhythm monitoring will be achieved using an insertable monitor or an implanted atrial lead of a cardiac implantable electronic device. Additionally, heart rate monitoring via photoplethysmography using a smartwatch and/or smartphone is performed for a period of six months. Data are analyzed for differences in ABC scores before and after ablation in relation to possible AF/AT recurrences. Furthermore, we are going to compare the sensitivity and specificity of different follow-up modalities post ablation. The monitoring via ICM (gold standard) is compared to smartwatch-based monitoring alone, versus smartphone-based monitoring alone or a combination of both for AT/AF recurrences.

Conditions

Atrial Flutter; Stroke; Bleeding; Atrial Remodeling; Recurrences; Atrial Fibrillation

Keywords

Atrial Fibrillation; Atrial Flutter; ABC score; Wearables; Stroke risk; Bleeding risk; Photoplethysmography; Implantable loop recorder

Outcome Measures

Primary Outcomes (6)

• Impact of catheter ablation of atrial tachycardias on the ABC stroke-score assessing the change 3,6 and 12 months after catheter ablation

  Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC stroke-score assessing the change 3 months after catheter ablation

  3 months after catheter ablation

• Impact of catheter ablation of atrial tachycardias on the ABC stroke-score assessing the change 3,6 and 12 months after catheter ablation

  Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC stroke-score assessing the change 6 months after catheter ablation

  6 months after catheter ablation

• Impact of catheter ablation of atrial tachycardias on the ABC stroke-score assessing the change 3,6 and 12 months after catheter ablation

  Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC stroke-score assessing the change 12 months after catheter ablation

  12 months after catheter ablation

• Impact of catheter ablation of atrial tachycardias on the ABC bleeding-score assessing the change 3,6 and 12 months after catheter ablation

  Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC bleeding-score assessing the change 3 months after catheter ablation

  3 months after catheter ablation

• Impact of catheter ablation of atrial tachycardias on the ABC bleeding-score assessing the change 3,6 and 12 months after catheter ablation

  Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC bleeding-score assessing the change 6 months after catheter ablation

  6 months after catheter ablation

• Impact of catheter ablation of atrial tachycardias on the ABC bleeding-score assessing the change 3,6 and 12 months after catheter ablation

  Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC bleeding-score assessing the change 12 months after catheter ablation

  12 months after catheter ablation

Secondary Outcomes (4)

• Number of clinical events post catheter ablation in relation to ABC score-predicted risks

  3,6 and 12 months after catheter ablation

• Number of clinical events post catheter ablation in relation to traditional score-predicted risks

  3,6 and 12 months after catheter ablation

• Impact of the recurrence rate after catheter ablation on the ABC stroke- and bleeding risk scores

  3,6 and 12 months after catheter ablation

• Comparison of insertable cardiac monitor vs. smartwatch vs. smartphone-based follow-up with respect to atrial tachycardias (AT) / atrial fibrillation (AF) recurrences post catheter ablation

  Wearables: within the first 6 months after catheter ablation, implantable loop recorder: 3,6 and 12 months after catheter ablation

Interventions

Catheter ablation PROCEDURE

Catheter ablation of atrial tachyarrhythmia (atrial fibrillation, atrial flutter)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients planned to undergo first catheter ablation for symptomatic atrial tachyarrhythmias (atrial fibrillation, atrial flutter) will be enrolled.

You may qualify if:

• Symptomatic atrial tachyarrhythmias (atrial fibrillation, atrial flutter)
• Planned for 1st right or left atrial ablation
• Informed consent
• at least 18 years

You may not qualify if:

• Previous left or right atrial ablation
• Ineligibility for catheter ablation
• History of TIA / stroke
• \< 18 years
• LA thrombus formation or history of thrombus formation

Sponsors & Collaborators

• Hannover Medical School: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (14)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Stroke; Hemorrhage; Atrial Remodeling; Recurrence

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Disease Attributes

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• David Duncker, Prof. Dr.

  Hannover Medical School, Carl-Neuberg Str. 1, 30625 Hannover

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: December 2, 2022
• Study Start: June 3, 2021
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: March 5, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)