A prospective, randomized, controlled,interventional, single-blinded, multi-center, post-market, global CRT in heart failure (HF) clinical study.
- Conditions
- Health Condition 1: null- Subject is indicated for a CRT device according to local guidelines
- Registration Number
- CTRI/2016/04/006799
- Lead Sponsor
- India Medtronic Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 55
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the composite of all-cause death and any intervention for heart <br/ ><br>failure decompensation as adjudicated by the EAC.Timepoint: 2 years after enrollment
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: None