CompletedPhase 4

Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF

Germany44 participantsStarted 2005-06

Plain-language summary

The primary objective of this study is to compare the Apnea- Hypopnea Index in HF patients with concomitant CSA, after 12 weeks of CRT alone to CRT in combination with one night of overdrive pacing. Secondary objectives are to evaluate the effects of a single night of overdrive pacing applied after 12 weeks of CRT vs. CRT alone on breathing events, sleeping events, and neurohormonal markers. An additional secondary objective of the study is to compare the efficacy of CRT in HF patients with concomitant CSA to HF patients without concomitant CSA.

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with documented clinical history of symptomatic but stable congestive heart failure, NYHA III or NYHA IV, of at least six weeks duration. * Patient has an indication for a CRT device, or patients with previous pacemaker indication, except Sick Sinus Syndrome, and currently in need for an upgrade to a CRT device * Patient is scheduled for the implantation of a CRT device * Patient is over 18 years of age * Patient provides Informed Consent Exclusion Criteria: * Inability to complete overnight sleep study as specified by the protocol * Myocardial infarction or coronary revascularization procedure within 2 calendar months prior to enrollment * Planned or strong likelihood of cardiac surgery within 4 months following enrollment * A spirometric confirmation of obstructive lung disease * Evidence of obstructive sleep apnea at baseline polysomnography * Body mass index \>30 kg/m² * Pregnant women

What they're measuring

AHI

Timeframe: 12 weeks

Trial details

NCT IDNCT00551499

SponsorMedtronic Cardiac Rhythm and Heart Failure

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-12