Status:
TERMINATED
Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Heart Failure (HF)
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
EffecT is a prospective, randomized multicenter study to assess whether management of atrial fibrillation (AF) as well as the early optimization of cardiac resynchronization therapy (CRT) via Home Mon...
Detailed Description
EffecT is a prospective, randomized multicenter study to assess whether management of atrial fibrillation as well as the early optimization of cardiac resynchronization therapy via Home Monitoring dec...
Eligibility Criteria
Inclusion
- Indication for CRT with ICD-backup
- Paroxysmal or persistent AF
- Optimized HF-related medication
Exclusion
- Permanent AF
- Contraindication for anticoagulation
- Stroke within the last 6 weeks
- Acute coronary syndrome within the last 2 months
- Cardiac surgery within the last 2 months
- Acute myocarditis
- Severe chronic obstructive pulmonary disease (COPD)
- Planned cardiac surgery or interventional measures within the coming 3 months
- Dialysis dependency
- Life expectancy \< 12 months
- Insufficient GSM (Global System for Mobile Communication)/GPRS (General Packet Radio Service)-network coverage
- Previously implanted unipolar right atrial lead
- Previously implanted right atrial lead with tip-ring distance \> 11 mm
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT00811382
Start Date
May 1 2008
End Date
September 1 2015
Last Update
August 29 2024
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
A.Z. Middelheim
Antwerp, Belgium
2
AZ St. Jan
Bruges, Belgium
3
Nemocnice Ceske Budejovice
České Budějovice, Czechia
4
FN Olomouc
Olomouc, Czechia