NL-OMON48055
Withdrawn
Not Applicable
A randomized controlled trial of AV junction ablation and biventricular pacing versus optimal pharmacological therapy in patients with permanent atrial fibrillation - APAF-CRT Long-term Outcome
'Nuccia e Vittore Corbella' Centrum preventie hart-en longziekten te Rapallo (Genua)0 sites30 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- 'Nuccia e Vittore Corbella' Centrum preventie hart-en longziekten te Rapallo (Genua)
- Enrollment
- 30
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a) Permanent AF (\> 6 months) which has been considered unsuitable for AF
- •ablation or which resulted in failed AF ablation;
- •b) Severely symptomatic (AF\-related symptoms), refractory to drug therapy
- •for rate control;
- •c) QRS duration \* 110 ms;
- •d) At least one hospitalization related to AF and/or heart failure in the
- •previous year (see definition in section IV. Statistical Methods and Data
- •Analysis in protocol);
Exclusion Criteria
- •a) Patient is less than 18 years of age;
- •b) NYHA class IV and systolic blood pressure \* 80 mmHg despite optimal
- •c) Myocardial infarction within the previous 3 months;
- •d) Previously implanted cardiac devices (pacemaker/ICD/CRT) with \*5%
- •pacing function. Patients who had devices implanted that had \<5% of paced beats
- •(i.e., back\*up
- •pacing) can be enrolled;
- •e) Severe concomitant non\-cardiac disease;
- •f) Need for surgical intervention. (Cardiac surgery is scheduled)
- •g) Patients with LVEF \>50% are excluded
Outcomes
Primary Outcomes
Not specified
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Unknown
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