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

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ClinicalTrials.gov Identifier: NCT04053361
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Stepan Havranek, General University Hospital, Prague

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Pulmonary Hypertension Procedure: Catheter ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Catheter Ablation of Atrial Fibrillation/Tachycardia in Patients With Pulmonary Hypertension: a Randomised Study
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A: Clinical ablation
  • Cinical arrhythmia is fairly documented AF, pulmonary vein isolation will be performed. If AF persists after this step, electrical cardioversion will be performed.
  • If clinical arrhythmia is fairly documented type 1 AFL, cavo-tricuspid isthmus ablation will be performed.
  • If clinical arrhythmia is AT, it will be induced (if not persistent), identified by means of activation and/or entrainment mapping, and ablated.
  • If clinical arrhythmia is AT that is non-inducible during EP study, no ablation will be done.
  • If other incidental (or induced) AT is observed that can be qualified as non-clinical it will not be targeted unless considered important to ablate at discretion of operator.
  • No induction protocols for other, on top of already ablated, arrhythmias will be attempted.
Procedure: Catheter ablation
Catheter ablation of atrial fibrillation or atrial tachykardie related to atrial fibrillation with use of radiofrequency energy.

Experimental: Group B: Clinical plus substrate-based ablation

- The initial ablation steps will be identical to those in patients from Group A.

Supplemental ablation will consist of:

  • Empirical lesion set within right atrium: superior vena cava isolation, posteroseptal bicaval line, and cavo-tricuspid isthmus ablation (if not already ablated)

AND

  • Homogenization of low-voltage zones (if any) in left / right atrium defined by bipolar voltage <0.5 mV in sinus rhythm or <0.2 mV in AF / AT. The threshold can be adapted in severely diseased atria to delineate reasonably smaller zones (<20% of atrial surface) achievable to ablate.
  • Arrhythmia induction protocol by10-second burst atrial pacing with cycle length of 300 ms decremented by 10 ms up to atrial refractoriness or cycle length of 200 ms.
  • Inducible ATs will be mapped and ablated if feasible. In case of inducible persistent (>5 min) AF, pulmonary vein isolation will be performed if not previously done as per protocol.
Procedure: Catheter ablation
Catheter ablation of atrial fibrillation or atrial tachykardie related to atrial fibrillation with use of radiofrequency energy.




Primary Outcome Measures :
  1. Arrhythmia recurrence [ Time Frame: 3 months ]
    Documented arrhythmia recurrence >30 s without antiarrhythmic drugs in post-blanking period after the index ablation


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053361


Contacts
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Contact: Stepan Havranek, M.D. +420723085848 stepan.havranek@vfn.cz

Locations
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Czechia
FN Olomouc Recruiting
Olomouc, Czechia, 77900
Contact: Tomas Skala         
IKEM Recruiting
Prague, Czechia, 10000
Contact: Dan Wichterle    +420224963418    wichterle@hotmail.com   
General University Hospital in Prague Recruiting
Prague, Czechia, 12808
Contact: Stepan Havranek    +420723085848    stepan.havranek@centrum.cz   
Sponsors and Collaborators
General University Hospital, Prague

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Responsible Party: Stepan Havranek, Consultant, General University Hospital, Prague
ClinicalTrials.gov Identifier: NCT04053361     History of Changes
Other Study ID Numbers: GH-18-02-00027-0-202
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stepan Havranek, General University Hospital, Prague:
Atrial Fibrillation
Pulmonary Hypertension
Catheter Ablation
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Atrial Fibrillation
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases