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Linear catheter ablation by DC-shock

Linear catheter ablation by DC-shock - ACDC-linear

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36286
Enrollment
30
Registered
2011-04-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Atrial fibrillation

Interventions

The following extra actions are required for linear DC-ablations: 1. Instead of a non-steerable sheath through the interatrial septum we will use a steerable sheath. The steerable sheath is registere

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Persistent atrial fibrillation

Exclusion criteria

Exclusion criteria: Patients who have undergone a previous catheter ablation procedure for atrial fibrillation.

Design outcomes

Primary

MeasureTime frame
Adequate position of the linear DC-ablatie caheter. This is defined be visually good wallcontact by intracardiac ultrasound (ICE) and electrical signals from the electrodes on the linear ablation catheter Acute effect. This is defined as a successful ablation line with a complete and bidirectional electrical block. Adverse events. 1. Pericardial effusion 2. Cardiac tamponade 3. Thrombo-embolic complications 4. Illness or trauma due to catheter ablation 5. Temporary or permanent loss of bodily function 6. Any event that leads to early abortion of the procedure 7. Any event that leads to prolonged hospitalization 8. Any event that leads to a surgical intervention 9. Death Clinical one-year follow-up. 1. Documented atrial fibrillation or atrial tachycardia of >30 seconds duration, confirmed by a 12-channel ECG or Holter-ECG 2. Occurance of abovementioned adverse events during the outpatient time period.

Secondary

MeasureTime frame
We will register the duration of the total ablation procedure and the duration of the individual phases of the procedure: 1. The time necessary to position the linear catheter on any of the 2 target areas and the time of the ablations in both areas. 2. The necessity of using the steerable sheath for the correct positioning of the linear catheter will also be investigated in this pilot study.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)