Cryoballoon pulmonary-vein isolation
ProcedureElectrical isolation of the pulmonary-veins using cryoenergy
NCT Number: NCT04906668
As patients age, symptom control and treatment of atrial fibrillation become equally difficult, often leading to increased hospitalization. ABLATE versus PACE is a prospective, randomized clinical trial comparing pacemaker implantation with AV node ablation with pulmonary vein isolation in terms of rehospitalization and quality of life in patients with persistent AF aged 75 years and older.
This study is active but is not currently recruiting participants.
Notify Me75 year–99 year
All sexes
Interventional
Not applicable
Universitätsklinikum Innsbruck, Innsbruck, Austria
Atrial fibrillation is the most common cardiac arrhythmia and is a major public and represents a major public health problem with increasing healthcare costs and increased mortality risk.
In case of recurrent symptomatic atrial fibrillation current guidelines recommend pulmonary-vein isolation (PVI) as invasive treatment option. However, 5-year arrhythmia-free survival estimate is 29% after single catheter ablation. Although the long-term success rates in maintaining sinus rhythm are higher than with drug-based rhythm control, they are still moderate, especially in older patients with comorbidities. Therefore, repeated interventions are often necessary.
An effective method for frequency control is atrioventricular (AV) node ablation after implantation of a pacemaker ("ablate-and-pace"). In this case, the ventricular rate is only set by the pacemaker and can be programmed according to the patient's needs.
There are some theoretical disadvantages of this treatment option (pacemaker dependency, reduction of cardiac outpout due to lack of atrial contraction) which is why this method nowadays is almost exclusively used in older (and physically less active) patients.
The ABLATE versus PACE trial is a prospective randomized clinical trial comparing at 196 these two treatment options in terms of rehospitalizations due to cardiovascular causes and quality of life in elderly patients (≥ 75 years) with normal ejection fraction (≥ 50%).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Electrical isolation of the pulmonary-veins using cryoenergy
Pacemaker implantation and ablation of atrioventricular-node
Time frame: 36 months
except for protocol-indicated AVN ablation
Time frame: 36 months
Time frame: 36 months
Time frame: 36 months
Time frame: 36 months
(major bleeding by Bleeding Academic Research Consortium Definition (BARC ≥ 2) criteria, major groin site complications prolonging inpatient stay, pacemaker pocket bleeding prolonging inpatient stay, pericardial effusion, cerebrovascular or systemic embolism, phrenic nerve palsy, lead dislodgment, lead perforation, infection including pacemaker pocket infection, lead infection / pacemaker related endocarditis)
Time frame: 36 months
Time frame: 36 months
Scale 20-140 with higher score indicating worse quality-of-life.
Time frame: 36 months
Time frame: 36 months
Time frame: 36 months
Time frame: 36 months
St. Josefs-Hospital Wiesbaden GmbH
Other
Pulmonary-vein Isolation or Ablation of Atrioventricular-node and Pacemaker Implantation for Elderly Patients With Persistent Atrial Fibrillation (ABLATE Versus PACE)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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