Health Condition 1: null- Subject is indicated for a CRT device according to local guidelines
Conditions
Interventions
Intervention1: AdaptivCRT®, CardioSync®, and OptiVol®: multi-programmable CRT-D devices
that monitors and regulates a patientâ??s heart rate by providing single or dual chamber rateresponsive
brady
RV-synchronized LV pacing or sequential biventricular pacing
ventricular tachyarrhythmia therapies
and atrial tachyarrhythmia therapies
Control Intervention1: None: None
Sponsors
India Medtronic Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subject is willing to sign and date the study Patient Informed Consent (PIC) Form. ï?· Subject is indicated for a CRT device according to local guidelines. ï?· Subject has, minimally: o Sinus Rhythm at time of enrollment. o Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior to enrollment). Criteria16 for complete LBBB must include: ï?§ Intrinsic QRS duration >=140 ms (men) or >=130 ms (women), ï?§ QS or rS in leads V1 and V2, and ï?§ Mid-QRS notching or slurring in >=2 of leads V1, V2, V5, V6, I, and aVL. o Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or equal to 200ms (within 30 days prior to enrollment). o Left ventricular ejection fraction less than or equal to 35% (documented within 180 days prior to enrollment). o NYHA class II, III or IV (documented within 30 days prior to enrollment) despite optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose of Beta-blockers and a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist.
Exclusion criteria
Exclusion criteria: Subject is less than 18 years of age (or has not reached minimum age per local law). ï?· Subject is not expected to remain available for at least 2 years of follow-up visits. ï?· Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted ï?· Subject is, or previously has been, receiving cardiac resynchronization therapy. ï?· Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 30 days prior to enrollment. ï?· Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study. ï?· Subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded). ï?· Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study. ï?· Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to device implant). ï?· Subject meets any exclusion criteria required by local law.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the composite of all-cause death and any intervention for heart failure decompensation as adjudicated by the EAC.Timepoint: 2 years after enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: None | — |
Countries
India
Contacts
Public ContactVinay Rajan
India Medtronic Pvt. Ltd.
Outcome results
None listed