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

Primary Purpose

Atrial Fibrillation, Pulmonary Hypertension

Status
Active
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Catheter ablation
Sponsored by
General University Hospital, Prague
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Pulmonary Hypertension, Catheter Ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • FN Olomouc
  • IKEM
  • General University Hospital in Prague

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A: Clinical ablation

Group B: Clinical plus substrate-based ablation

Arm Description

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.

- 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

On-drugs arrhythmia recurrence
Documented on-drugs arrhythmia recurrence
Symptoms of arrhythmia
Symptoms of arrhythmia by questionare
Change in Quality of life
EQ5D
Mortality
Mortality of any cause
Procedure-related complication rate
Complications related to catheter ablation
Reablation
Number of repeat catheter ablations if symptoms are ongoing

Full Information

First Posted
June 28, 2019
Last Updated
March 20, 2022
Sponsor
General University Hospital, Prague
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1. Study Identification

Unique Protocol Identification Number
NCT04053361
Brief Title
Catheter Ablation of Atrial Fibrillation in Patients With Pulmonary Hypertension Hypertension: a Randomised Study
Official Title
Catheter Ablation of Atrial Fibrillation/Tachycardia in Patients With Pulmonary Hypertension: a Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General University Hospital, Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Pulmonary Hypertension
Keywords
Atrial Fibrillation, Pulmonary Hypertension, Catheter Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Clinical ablation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B: Clinical plus substrate-based ablation
Arm Type
Experimental
Arm Description
- 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.
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation
Intervention Description
Catheter ablation of atrial fibrillation or atrial tachykardie related to atrial fibrillation with use of radiofrequency energy.
Primary Outcome Measure Information:
Title
Arrhythmia recurrence
Description
Documented arrhythmia recurrence >30 s without antiarrhythmic drugs in post-blanking period after the index ablation
Time Frame
3 months
Secondary Outcome Measure Information:
Title
On-drugs arrhythmia recurrence
Description
Documented on-drugs arrhythmia recurrence
Time Frame
3 months
Title
Symptoms of arrhythmia
Description
Symptoms of arrhythmia by questionare
Time Frame
3 months
Title
Change in Quality of life
Description
EQ5D
Time Frame
6 months
Title
Mortality
Description
Mortality of any cause
Time Frame
3 months
Title
Procedure-related complication rate
Description
Complications related to catheter ablation
Time Frame
1 day (Once)
Title
Reablation
Description
Number of repeat catheter ablations if symptoms are ongoing
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
FN Olomouc
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
IKEM
City
Prague
ZIP/Postal Code
10000
Country
Czechia
Facility Name
General University Hospital in Prague
City
Prague
ZIP/Postal Code
12808
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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