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Use of a visualizable steerable sheath in ablation of persistent atrial fibrillation with the QDOT MICRO™ catheter (VISTA-Q-Study)

Use of a visualizable steerable sheath in ablation of persistent atrial fibrillation with the QDOT MICRO™ catheter (VISTA-Q-Study) - VISTA-Q-Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00031493
Enrollment
120
Registered
2023-04-14
Start date
2023-07-21
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Persistent atrial fibrillation

Interventions

Group 1: Pulmonary vein isolation with the Q-DOT Micro™ catheter and the Vizigo™ steerable sheath. Group 2: Pulmonary vein isolation with the Q-DOT Micro™ catheter and a non-steerable SL0 sheath.

Sponsors

Universitätsmedizin Mainz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Ablation of persistent atrial fibrillation < 6 months duration Initial procedure Presence of informed consent

Exclusion criteria

Exclusion criteria: Obesity with body mass index >35kg/m2 (due to expected higher complication rates). - Chronic renal insufficiency with s-creatinine >1.5mg/dl, GFR 6 month.

Design outcomes

Primary

MeasureTime frame
Catheter stability measured by the following surrogate parameters: Contact pressure Impedance drop

Secondary

MeasureTime frame
First-pass isolation or first-pass block Procedure duration Temperature development

Countries

Germany

Contacts

Public ContactRaphael Spittler

Universitätsmedizin

raphael.spittler@unimedizin-mainz.de06131177218

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026