Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05922917 |
| Other study ID # |
CZ-060620231904 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 20, 2023 |
| Est. completion date |
May 30, 2026 |
Study information
| Verified date |
June 2023 |
| Source |
Ceské Budejovice Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Since a new method called pulsed-field ablation (PFA) has emerged, allowing significantly
simpler, safer, and faster creation of ablative lesions in paroxysmal AF and PsAF (13),
redefining the "optimal" ablation approach started to appear mandatory. Our project (The
PIVCO study) aims to determine a more standardized procedure representing optimal ablation
strategy for patients suffering from PsAF using PFA and multielectrode ablation catheters.
The central hypothesis is that ablation of the posterior LA wall (PWI), together with mitral
and cavotricuspid isthmus ablation added on top of PVI, will be associated with better
effects in terms of rhythm control. Given the speed, safety, and ease of standardization of
ablation using electroporation, a demonstration of the superiority of either approach could
significantly impact the current standard of clinical care.
Description:
Purpose Since a new method called pulsed-field ablation (PFA) has emerged, allowing
significantly simpler, safer, and faster creation of ablative lesions in paroxysmal AF and
PsAF (13), redefining the "optimal" ablation approach started to appear mandatory. Our
project (The PIVCO study) aims to determine a more standardized procedure representing
optimal ablation strategy for patients suffering from PsAF using PFA and multielectrode
ablation catheters. The central hypothesis is that ablation of the posterior LA wall (PWI),
together with mitral and cavotricuspid isthmus ablation added on top of PVI, will be
associated with better effects in terms of rhythm control. Given the speed, safety, and ease
of standardization of ablation using electroporation, a demonstration of the superiority of
either approach could significantly impact the current standard of clinical care.
Primary endpoints
(1) The primary endpoint will be a recurrence of AF (or atrial tachycardia, AT) lasting >30
seconds as assessed using repeated 7-day ECG Holter monitoring in patients without
anti-arrhythmic drugs (AADs) during the entire post-blanking follow-up, i.e., starting three
months after the index procedure. All patients should complete a 12-month follow-up period.
Secondary endpoints
(1) The first recurrence of on-AADs AF/AT lasting >6 minutes during the post-blanking
follow-up period (i.e., disregarding all off-AAD episodes). (2) Number of hospitalizations
and emergency out-patient visits related to AF/AT recurrence, worsening of heart failure, or
other cardiovascular diseases. (3) Number of electrical cardioversions. (4) Proportion of
patients on AADs at the end of follow-up. (5) PFA-related complications. (6) Assessment of
the quality of life using standardized instruments (AFEQT, EQ5D). (7) Feasibility of
achieving a complete block of the mitral isthmus and PWI using PFA (8) Proportion of patients
with delayed conduction into LAA after mitral line (9) Number of patients that underwent
repeated ablations during follow-up.
Interventions
Procedures that will be performed on the day of admission for ablation:
1. 12-lead ECG
2. Randomization to group PVI or PVI+
3. Physical examination
4. Medication taken
5. Medical history
6. Laboratory tests (biochemistry - NTproBNP, K, urea, creatinine, ALT, AST, GMT, CRP; KO -
Hb, leu, PLT)
7. Cardiac CT scan as decided by the attending physician
8. Transthoracic echocardiography (left atrial [LA] dimension in PLAX, LAVi, transverse and
longitudinal LA dimension in A4CH, LA area in A4CH, left ventricular ejection fraction
(LV EF), LV dimension in PLAX, estimation of PASP, quantification of any valvular defect
9. Esophageal echocardiography (TEE) of the heart as decided by the attending physician to
exclude intracardiac thrombosis
10. Quality of life questionnaires (EQ5DY, AFEQT)
Catheter ablation strategy
In all patients, ablation will be performed by electroporation (Farapulse system), as
recommended, with at least two applications per each ablation spot. Based on the
randomization, patients will be treated using two distinct approaches:
Group PVI (Pulmonary vein isolation only)
1. No ablation at the cavotricuspid isthmus (CTI)
2. Transseptal puncture
3. PVI (plus application to the superior anterior aspect of the right superior pulmonary
vein [RSPV])
4. In the absence of AF termination - cardioversion
5. Induction - in case of persistent arrhythmia (regardless of regularity of activation in
the atria) - cardioversion, without further ablation outside PVI
Group PVI+ (Complex ablation procedure)
1. Transseptal puncture
2. PVI (plus application to the superior anterior aspect of the RSPV)
3. Roofline
4. Box isolation of the posterior wall of the left atrium (line on the LA roof between left
superior pulmonary vein [LSPV] and RSPV, the line between left inferior pulmonary vein
[LIPV] and right inferior pulmonary vein [RIPV])
5. Ablation along the coronary sinus (CS) from the endocardium, in the form of limited
energy application in the left postero-septum
6. Posterolateral mitral isthmus line
7. In the absence of termination of AF to SR or when AF is converted to AT, cardioversion
will be performed
8. Verification and eventual completion of the bidirectional mitral line conduction block
9. Ablation at CTI - completion of the bidirectional conduction block
10. Induction (burst atrial pacing from proximal CS at different cycle lengths of 300 ms,
250 ms, and 200 ms, each step for 5-10 seconds; then RAMP pacing 300-200 ms)
11. If AF or AT is induced, cardioversion will be performed
Follow-up The following information will be recorded on the day of discharge: Date of
hospital discharge after ablation, length of in-hospital stays, early complications of
ablation, and medication at the discharge (all antiarrhythmic drugs except beta-blockers will
permanently be discontinued at hospital discharge).
Four 7-day Holter ECG monitoring recordings will be done at 3, 6, 9, and 12 months after
ablation (in case of recurrence of AF after ablation, standard treatment according to the
treating physician's decision, including the possibility of antiarrhythmic medication,
electrical cardioversion or repeated ablation, will be applied).
A telephone visit be done at 1, 3, 6, and 9 months after ablation with an inquiry about
complications of the ablation procedure, perceived recurrence of AF, use of antiarrhythmic
and antithrombotic medication, elective cardioversion, hospitalization, and reasons for it.
An in-office visit will be done 12 months after ablation in the hospital's out-patient
department, including an inquiry about complications of the ablation procedure, perceived and
documented recurrence of AF, use of antiarrhythmic and antithrombotic medication, elective
cardioversion, hospitalization and reasons for it after ablation, physical examination,
medication history, ECG, echocardiography and quality of life questionnaires.
