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OpenTrials
Completed

NCT Number: NCT00789139

Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM

Post Marketing study, Interventional, Prospective, non randomised

Describe how the MD is using the information of the ICM in addition of standard FU(clinical exam and holter 24h)post AF ablation(1 year FU).

Completed

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saint Joseph Hospital

Marseille, 13008, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • AF thermoablation indication
  • Informed Consent signed,
  • Age between 18 & 75

Exclusion criteria

  • Participation to other clinical trial
  • Non compliant patient
  • Pregnant women
  • Left Atrial thrombus
  • Endocarditis, infection

Treatment and study plan

ICM Implantation

Device

Sub cutaneous implantation of the ICM

Primary outcomes

  1. Clinical exam and ECG record

    Time frame: one month, 3 months, 6 months , 12 months

Sponsors and collaborators

Lead sponsor

Dr Ange FERRACCI

Other

Registry information

Acronym: RAPID XT

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Nov 11, 2008
Registry last updated
Jun 19, 2015

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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