STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-009739
NCT ID: NCT04428944
Sponsor Protocol Number: MHICC-2020-004
About this study
The purpoose of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF: 1. PV antral isolation alone (PVAI) 2. PV antral isolation plus ablation of drivers (PVAI+drivers) 3. PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
1. Patients 18 years of age or older
2. Patients undergoing first-time ablation procedure for AF
3. Patients with persistent AF defined as a sustained episode more than 3 months but less
than three years
4. Patients with symptomatic AF - symptomatic patients are those who have been aware of
their AF at any time within the last 5 years prior to enrolment. Symptoms may include,
but are not restricted to, palpitations, shortness of breath, chest pain, fatigue,
left ventricular dysfunction, or other symptoms or any combination of the above
5. Patients whose AF has been refractory to at least one antiarrhythmic drug
6. At least one episode of AF must have been documented by ECG, holter, loop recorder,
telemetry, trans-telephonic monitor or implanted device within the last 2 years from
enrolment
7. Patients must be able and willing to provide written informed consent to participate
in the study
Exclusion Criteria:
1. Patients with paroxysmal AF (no episodes lasting > 7 days)
2. Patients with early persistent AF, sustained episode ≤ 3 months
3. Patients with very long lasting persistent AF (episodes lasting > 3 years)
4. Patients with CHA2DS2-VASc score of 0.
5. Patients for whom cardioversion or sinus rhythm will never be attempted/pursued
6. Patients with AF felt to be secondary to an obvious reversible cause
7. Patients with contraindication to oral anticoagulation or systemic anticoagulation
with heparin
8. Patients with left atrial diameter > 60 mm in the parasternal long axis view
9. Patients who are pregnant
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 10/19/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available