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OpenTrials
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NCT Number: NCT04053361

Catheter Ablation of Atrial Fibrillation in Patients With Pulmonary Hypertension Hypertension: a Randomised Study

Atrial fibrillation (AF) and atrial tachycardia (AT), including type I atrial flutter, are frequently observed in patients with pulmonary hypertension (PH). Catheter ablation of AF / AT has been established as an effective treatment option in selected patients. However, little is known about the efficacy and safety of this approach in patients with PH. It has also been shown that considerable proportion of patients with PH after acutely successful catheter ablation suffer from the recurrence of clinical or newly manifested arrhythmia. We propose a prospective study to compare two ablation strategies in a randomized fashion: radiofrequency catheter ablation targeting only the clinical arrhythmia versus more extensive substrate-based catheter ablation. This project will investigate the clinical outcome of patients with pulmonary hypertension and symptomatic atrial fibrillation / tachycardia who will be randomly allocated to selective versus complex radiofrequency catheter ablation of arrhythmogenic substrate.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Hypertension Hypertension, Pulmonary Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FN Olomouc, Olomouc, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pre-capillary PH (PAMP ≥25 mmHg; PAWP ≤15 mmHg) or combined post- a pre-capillary PH (PAMP ≥25 mmHg; PAWP >15 mmHg; DPG ≥7 mmHg and/or PVR >3 W.u.) of any etiology.

Exclusion criteria

  • Complex congenital heart defects (corrected or uncorrected)
  • Isolated post-capillary PH (PAMP ≥25 mmHg; PAWP >15 mmHg; DPG <7 mmHg and/or PVR ≤ 3W.u.)
  • Previous catheter ablation for AF / AT / AFL
  • Previous or scheduled cardiac surgery-
  • NYHA Class IV, cardiogenic shock
  • Life expectancy <1 year
  • Non-compliance

Treatment and study plan

Catheter ablation

Procedure

Catheter ablation of atrial fibrillation or atrial tachykardie related to atrial fibrillation with use of radiofrequency energy.

Primary outcomes

  1. Arrhythmia recurrence

    Time frame: 3 months

    Documented arrhythmia recurrence >30 s without antiarrhythmic drugs in post-blanking period after the index ablation

Secondary outcomes

  1. On-drugs arrhythmia recurrence

    Time frame: 3 months

    Documented on-drugs arrhythmia recurrence

  2. Symptoms of arrhythmia

    Time frame: 3 months

    Symptoms of arrhythmia by questionare

  3. Change in Quality of life

    Time frame: 6 months

    EQ5D

  4. Mortality

    Time frame: 3 months

    Mortality of any cause

  5. Procedure-related complication rate

    Time frame: 1 day (Once)

    Complications related to catheter ablation

  6. Reablation

    Time frame: 3 months

    Number of repeat catheter ablations if symptoms are ongoing

Sponsors and collaborators

Lead sponsor

General University Hospital, Prague

Other

Registry information

Official study title

Catheter Ablation of Atrial Fibrillation/Tachycardia in Patients With Pulmonary Hypertension: a Randomised Study

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2019
Registry last updated
Feb 26, 2024

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

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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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