An interventional study of Pulmonary vein isolation exclusively with radiofrequency and Pulmonary vein isolation exclusively with pulsed field ablation in Atrial Fibrillation, sponsored by Hospital General Universitario de Alicante. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-08.
Sponsored by Hospital General Universitario de Alicante · Not applicable, Interventional, and Treatment
Pulmonary vein (PV) isolation is considered the therapeutic strategy of choice to maintain sinus rhythm (SR) in symptomatic patients with atrial fibrillation (AF). The most commonly used energy modality is radiofrequency (RF). However, this type of energy presents notable challenges, such as its lack of selectivity for myocardial tissue, which increases the risk of serious complications such as atrioesophageal fistula, PV stenosis, and vagus nerve injuries. In this context, PV isolation using pulsed field ablation (PFA) emerges as a promising alternative due to its greater myocardial selectivity. However, this selectivity presents additional challenges. Preliminary studies indicate that PFA may not damage the autonomic nervous system (ANS) involved in the initiation and maintenance of AF in certain patients, although stronger evidence is needed to support this claim.
The investigators propose to carry out a single-center clinical trial, although with the possibility in the future of including other centers. Patients will be randomized to three research groups: PV isolation with RF, PV isolation with PFA, and PV isolation combining PFA and RF (using RF on the anterior wall and PFA on the posterior wall). This assignment will be open to the operator who performs the procedure, but blind for the researcher responsible for monitoring and for the data analyst. The objective is to compare the impact of different energy sources during PV isolation on the ability to produce a permanent alteration in the ANS. The hypothesis is that combined PF isolation will be capable of producing a permanent alteration of autonomic function parameters superior to ablation using exclusive PFA.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's planned enrollment of 156 is close to the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Hospital General Universitario de Alicante is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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- Patients with a diagnosis of paroxysmal atrial fibrillation, referred to our center for pulmonary vein isolation, who are willing and able to sign the informed consent.
Exclusion Criteria:
The ablation of the anterior and posterior wall will be performed with radiofrequency.
Procedure: Pulmonary vein isolation exclusively with radiofrequency
The ablation of the anterior and posterior wall will be performed with pulsed field ablation.
Procedure: Pulmonary vein isolation exclusively with pulsed field ablation
The ablation of the anterior wall will be performed with radiofrequency, and the posterior wall with pulsed field ablation.
Procedure: Combined pulmonary vein isolation
The QDOT (Biosense Webster, Inc.) or TactiFlex (Abbott S.E.) catheters will be used. The ablation will be controlled by temperature, with a limit of 42ºC and a power target of 30-40W. A high-power strategy (90 W/4 seconds) can be used on the posterior wall when the QDOT catheter is used.
The Sphere-9 catheter will be used (with biphasic and unipolar wave), with a duration per application of 5 seconds and a separation between lesions of 5-6mm. The target temperature increase will be at least 1.5ºC above the patient's basal temperature to mark the ablation as effective.
The Sphere-9 catheter will be used for both radiofrequency and pulsed field ablation. When using radiofrequency, the ablation will be temperature controlled, with a target temperature of 73ºC. The duration per application will be 5 seconds. Catheter irrigation during ablation will be 30ml/min, with a maximum current intensity of 3700mA, and a maximum current density of 13.6mA/mm2. The separation between lesions will be 7-8mm. Regarding pulsed field ablation, the characteristics will be those indicated in "Pulmonary vein isolation exclusively with pulsed field ablation" group.
Efficacy primary outcome: Alteration of autonomic function parameters
Determine if combined pulmonary vein isolation (anterior wall ablation with radiofrequency and posterior wall ablation with pulsed field ablation) will be capable of producing a permanent alteration of autonomic function parameters (average heart rate) greater than exclusive pulsed field ablation.
Time frame: Two years
Efficacy secondary outcome: Alteration of autonomic function parameters
Determine if combined pulmonary vein isolation (anterior wall ablation with radiofrequency and posterior wall ablation with pulsed field ablation) will be capable of producing a permanent alteration of autonomic function parameters (attenuation of heart rate variability) greater than exclusive pulsed field ablation.
Time frame: Two years
Efficacy secondary outcome: Alteration of autonomic function parameters
Determine if combined pulmonary vein isolation (anterior wall ablation with radiofrequency and posterior wall ablation with pulsed field ablation) is at least as effective as exclusive radiofrequency pulmonary vein isolation in its ability to produce a permanent alteration of autonomic function parameters (average heart rate).
Time frame: Two years
Efficacy secondary outcome: Alteration of autonomic function parameters
Determine if combined pulmonary vein isolation (anterior wall ablation with radiofrequency and posterior wall ablation with pulsed field ablation) is at least as effective as exclusive radiofrequency pulmonary vein isolation in its ability to produce a permanent alteration of autonomic function parameters (attenuation of heart rate variability).
Time frame: Two years
Efficacy secondary outcome: Procedure duration.
Determine if combined pulmonary vein isolation or exclusive pulmonary vein isolation with pulsed field ablation will shorten procedure times compared to exclusive radiofrequency pulmonary vein isolation.
Time frame: Two years
Start is estimated for Jun 2024; primary completion for Jun 2026, 24 months later.
Of 789 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 24 months is below that.
Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Hospital General Universitario de Alicante