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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04053361
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	General University Hospital, Prague
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Czechia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Atrial Fibrillation, Pulmonary Hypertension

Arms & Interventions

Arms

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.

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.

Interventions

Procedure: - Catheter ablation

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

Contact a Trial Team

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International Sites

FN Olomouc, Olomouc, Czechia

Status

Address

FN Olomouc

Olomouc, , 77900

IKEM, Prague, Czechia

Status

Address

IKEM

Prague, , 10000

General University Hospital in Prague, Prague, Czechia

Status

Address

General University Hospital in Prague

Prague, , 12808

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