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OpenTrials
Completed

NCT Number: NCT02816268

Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

The investigators prospectively investigate the differences between contact-force guided pulmonary vein isolation (PVI) and conventional pulmonary vein isolation in patients with paroxysmal atrial fibrillation (PAF) with respect to adenosine guided unmasking of dormant conduction, procedural and clinical outcome.

Completed

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Key information

Conditions

Improving Outcome After Pulmonary Vein Isolation

Study type

Interventional

Phase

Not applicable

Primary location

Deutsches Herzzentrum München

Munich, 80636, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients (>=18 und < 80 years) with symptomatic paroxysmal AF
  • At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III).
  • Oral anticoagulation with phenprocoumone, warfarine or DOAKs for at least 4 weeks prior to ablation with weekly documented INR > 2..
  • Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone.

Exclusion criteria

  • Left atrial thrombus
  • Contraindications for oral anticoagulation or adenosin

Treatment and study plan

Pulmonary vein isolation

Other

Primary outcomes

  1. Number of reconnected pulmonary vein after ablation and a waíting period of 20min

    Time frame: 20min after procedure

Secondary outcomes

  1. Time to first documented recurrence of atrial fibrillation

    Time frame: 12 month

  2. Complications due to ablation

    Time frame: 30 days

  3. Number of reconnected pulmonary veins

    Time frame: 12 month

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Acronym: FULL CONTACT

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jun 28, 2016
Registry last updated
Jun 28, 2016

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.