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Near zero-fluoroscopy ablation of atrial fibrillation/left atrial flutter/left atrial tachycardia - safety and effectivity (pilot study)

Near zero-fluoroscopy ablation of atrial fibrillation/left atrial flutter/left atrial tachycardia - safety and effectivity (pilot study)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025560
Enrollment
112
Registered
2021-06-16
Start date
2021-07-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I48.9

Interventions

Group 1: The planned ablation procedure of atrial fibrillation, left atrial atrial flutter or left atrial tachycardia at the University Heart Center Freiburg Bad Krozingen (Campus Bad Krozingen) was p

Sponsors

UNIVERSITÄTSKLINIKUM FREIBURGCampus Bad Krozingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: (a) patients scheduled for catheter ablation treatment of atrial fibrillation, left atrial atrial flutter, or left atrial atrial tachycardia (b) males and females at least 18 years of age.

Exclusion criteria

Exclusion criteria: a) Age <18 years b) Contraindication to catheter ablation treatment or magnetic resonance imaging of the heart.

Design outcomes

Primary

MeasureTime frame
a.Feasibility of transseptal puncture by pure X-ray-free 3D mapping control. b.Occurrence of specific potential study-associated complications (vascular injury, pericardial effusion, pulmonary vein stenosis). c.Total X-ray exposure time (in minutes and seconds) and X-ray dose (measured as dose area product) during the procedure.

Secondary

MeasureTime frame
a. X-ray radiation duration and dose (as shown above) recorded for the procedural individual steps (3D mapping, transseptal puncture, and ablation). b. Procedure duration c. Ablation number, time d. Recording of overall complication rate (including non-study-associated complications, intra- and post-procedural) e. Recurrence at follow-up (3 and 6 months).

Countries

Germany

Contacts

Public ContactHeiko Lehrmann

UNIVERSITÄTSKLINIKUM FREIBURGCampus Bad Krozingen

heiko.lehrmann@universitaets-herzzentrum.de+49 7633 402-4343

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026