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The PVAI+ trial


- candidate number16925
- NTR NumberNTR4467
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-mrt-2014
- Secondary IDs48677 ABR
- Public TitleThe PVAI+ trial
- Scientific TitlePVAI alone vs. PVAI plus ablation of CFAE's in a specific area of the left atrium in patients suffering from (longstanding) persistent atrial fibrillation
- ACRONYMPVAI+
- hypothesisThe hypothesis is that adding ablations of complex fractionated atrial electrograms (CFAE) in a restricted area of the left atrium to pulmonary vein antrum isolation (PVAI) in patients suffering from (longstanding) persistent atrial fibrillation, is superior to the standard care PVAI alone.
- Healt Condition(s) or Problem(s) studiedAtrial Fibrillation, Catheter ablation
- Inclusion criteria- Patients age is > 18 years - Patients with persistent or longstanding persistent atrial fibrillation. Persistent AF is defined as sustained episodes of atrial fibrillation lasting >7 days. Longstanding persistent AF is defined as sustained episode lasting >1 year - Patients undergoing a first time ablation procedure for persistent atrial fibrillation - AF must be recorded at least once by ECG, holter, telemetry, loop recorder or internal device. - Patients must give informed consent to participate
- Exclusion criteria- Patients suffering from paroxysmal atrial fibrillation. Paroxysmal AF is defined as episodes of AF that terminates spontaneously within 7 days. - Patients with any exclusion criteria or contra-indications for electrophysiologic study and ablation in the left atrium, such as pregnancy or presence of a left atrial thrombus - Prior PVAI with RF or Cryo ablation - Not capable of giving informed consent
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2014
- planned closingdate1-jun-2016
- Target number of participants90
- Interventions- The standard care group: pulmonary vein antrum isolation alone - The PVAI+ group: pulmonary vein antrum isolation plus limited ablation of CFAE’s in a specific region of the left atrium (under the right inferior pulmonary vein, the inferior left atrial septum, ostium and roof of the coronary sinus)
- Primary outcomeThe primary objective of the study is to evaluate which ablation strategy- PVAI alone or PVAI plus limited ablation of CFAE’s in a specific region of the left atrium- is most effective in treating persistent and longstanding persistent atrial fibrillation measured by success at 12 months after 1 or 2 procedures.
- Secondary outcome-procedural duration -fluoroscopy time -number of repeat procedures -number of patients showing CFAE in the particular region of the left atrium -incidence of periprocedural complications -quality of life measurements before and after ablation
- TimepointsFollow up will take place at 3,6 and 12 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES C. Teunissen
- CONTACT for SCIENTIFIC QUERIES C. Teunissen
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summaryIntroduction
PVAI, especially in those with paroxysmal AF, can prevent the initiation of AF. Over the last years catheter ablation is being applied increasingly in patients with persistent and longstanding persistent AF. In these patients the outcome of PVAI is more disappointing. Different ablation strategies have developed over the years, with special focus on the ablation of complex fractionated atrial electrograms (CFAE) and additional linear ablation lesions. Recently, our focus shifted to fractionated electrograms in the area under the right inferior pulmonary vein, the inferior left atrial septum and the ostium and roof of the coronary sinus. Ablation of these CFAE led to good results (unpublished data).
Purpose
The primary objective of the study is to evaluate which ablation strategy- PVAI alone or PVAI plus limited ablation of CFAE’s in a specific region of the left atrium- is most effective in treating persistent and longstanding persistent atrial fibrillation measured by success at 12 months after 1 or 2 procedures.
Methods
The PVIA+ trial is a single center, randomized single-blind intervention study with a follow up of 12 months. 90 Patients will be randomized in either: o The standard care group: pulmonary vein antrum isolation o The PVAI+ group: pulmonary vein antrum isolation plus limited ablation of fractionated areas in a specific region of the left atrium.
The follow-up protocol is the same as the standard care. Patients will visit the outpatient clinic at 3, 6, and 12 months post-ablation.
- Main changes (audit trail)
- RECORD20-mrt-2014 - 14-apr-2014


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