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OpenTrials
Completed

NCT Number: NCT01724437

Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation

to assess the near-term (12 months) efficacy of pulmonary vein isolation.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Catheter Ablation Strategies Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Hamburg

Hamburg, 20246, Germany

About this study

The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein isolation using a standard approach compared to application of an additional acute procedural endpoint of unexcitability along the ablation line.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • written informed consent
  • age > 18 years
  • paroxysmal atrial fibrillation

Exclusion criteria

  • structural heart disease
  • intracardiac thrombus
  • reversible causes of atrial fibrillation
  • inability to take warfarin

Treatment and study plan

catheter based pulmonary vein isolation

Device

catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice

Primary outcomes

  1. time to AF and AT recurrence

    Time frame: 12 months

    recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring

Secondary outcomes

  1. procedure duration

    Time frame: completed (15 months)

    time needed to complete the procedure

  2. procedure safety

    Time frame: up to three days after the procedure

    complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Nov 9, 2012
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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